Mild Cognitive ImpairmentNCT05408689

Effects of Transcutaneous Electrical Nerve Stimulation (TENS) to Improve the Cognitive Functions in Older Adults

A study testing T1 TENS and Concha TENS in people with Mild Cognitive Impairment, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 55 to 85 years
Conditions the study is for: Mild Cognitive Impairment
What is being tested?: T1 TENS and Concha TENS
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 90 participants
Where: 1 siteHong Kong
Study dates: 23 May 2022to 23 Mar 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Should fulfil the diagnosis criteria of MCI (Albert et al., 2011):
Concern regarding a change in cognition
Impairment in one or more cognitive domains
Preservation of independence in functional abilities
no signs of dementia were to be present and confirmed by the medical staff and medical records.

Who cannot join

If their medical records reported a history of either psychiatric disorder, alcoholism, cerebral trauma, cerebrovascular disease, hydrocephalus, neoplasm, epilepsy, disturbances of consciousness, insulin-dependent diabetes mellitus or focal brain disorders;
Having active implants, such as cochlear implants, pacemaker;
Having wounds and diseased skin on the electrode position.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

The Hong Kong Polytechnic University
Hong Kong

Other trials in Hong Kong

About this study

Official title: A Randomized Controlled Clinical Trial of Transcutaneous Electrical Nerve Stimulation to Improve the Cognitive Functions in Older Adults

Recent evidence has shown that transcutaneous electrical nerve stimulation (TENS) was effective in improving the cognitive function in healthy adult and people with dementia. However, lacking of evidence investigated the effect of TENS in improving the cognitive function and reversing the occurrence of dementia during the period of mild cognitive impairment (MCI), which is the crucial period to prevent the significant loss of cognition function. Therefore, the main objective of this study is to investigate the optimal TENS treatment protocol in improving the cognitive function in older adults with MCI.

Read the detailed description

This study aims to investigate the effectiveness of 3 intervention protocols (1) In the T1 TENS group, the subject will receive TENS on T1 spine. (2) In the vagus nerve TENS group, the subject will receive TENS on the concha of left outer ear. (3) In the sham stimulation group, the subject will receive sham stimulation on the T1 spine, in improving the cognitive function in older adults with MCI.

Conditions: Mild Cognitive Impairment
Being tested: T1 TENS, Concha TENS, Control
Keywords: Cognitive function, Transcutaneous electrical nerve stimulation
Medical subject headings: Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

T1 TENSDevice
The subjects in Group A will received TENS (Burst mode, 9 pulses per burst, pulse frequency =160Hz, burst frequency=2Hz, intensity was set to trigger visible muscular twitches). Two 2 x 3 cm electrodes was attached on T1 level with 2 cm from the spine. Previous study has shown that it was effective to improve the cognitive function in subjects with Alzheimer's disease.
Concha TENSDevice
The subjects in Group B will received TENS (25Hz, 0.5mA) on the concha of left outer ear. The electrical stimulation was generated by the portable neurostimulator (Nemos®, Cerbomed, Erlangen, Germany) and was delivered by a titanium electrodes positioning on top of a silicon earplug. Previous study has shown that it was effective to improve the Accelerate extinction memory formation and retention in healthy young adults.
ControlDevice
The subjects in Group C will receive 30 min sham electrical stimulation on T1 by a placebo-TENS device. The Placebo-TENS was applied by an apparently identical TENS unit. The unit's power indicator light was illuminated, but the unit's electrical circuit had been manually disconnected inside. In order to shape the common mindset, all subjects (except those in the Control group) were informed that they might or might not feel an electrical current, as different stimulation parameters were being applied.

Study groups in NCT05408689
Study group	Role	What they receive
T1 TENS	Experimental	In this study, participants will be treated 30 min per day, 3 days per week, for 10 consecutive weeks Receives: Device: T1 TENS
Concha TENS	Experimental	In this study, participants will be treated 30 min per day, 3 days per week, for 10 consecutive weeks Receives: Device: Concha TENS
Control	Placebo comparator	In this study, participants will be treated 30 min per day, 3 days per week, for 10 consecutive weeks Receives: Device: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

Montreal cognitive assessment (MoCA)
The overall cognitive function is measured by the Cantonese version of MoCA. The MoCA is a widely used 10-minute cognitive screening test for detection of MCI. The MoCA test includes 8 parts with a maximum score of 30. A higher score indicated a better cognitive function. The Cantonese version of MoCA has shown good to excellent inter-rater (ICC=0.987, p<0.001) reliability in Chinese older adults.
Measured: Baseline (0 week)
Montreal cognitive assessment (MoCA)
The overall cognitive function is measured by the Cantonese version of MoCA. The MoCA is a widely used 10-minute cognitive screening test for detection of MCI. The MoCA test includes 8 parts with a maximum score of 30. A higher score indicated a better cognitive function. The Cantonese version of MoCA has shown good to excellent inter-rater (ICC=0.987, p<0.001) reliability in Chinese older adults.
Measured: Mid-intervention (5 week)
Montreal cognitive assessment (MoCA)
The overall cognitive function is measured by the Cantonese version of MoCA. The MoCA is a widely used 10-minute cognitive screening test for detection of MCI. The MoCA test includes 8 parts with a maximum score of 30. A higher score indicated a better cognitive function. The Cantonese version of MoCA has shown good to excellent inter-rater (ICC=0.987, p<0.001) reliability in Chinese older adults.
Measured: Post-intervention (10 week)
Montreal cognitive assessment (MoCA)
The overall cognitive function is measured by the Cantonese version of MoCA. The MoCA is a widely used 10-minute cognitive screening test for detection of MCI. The MoCA test includes 8 parts with a maximum score of 30. A higher score indicated a better cognitive function. The Cantonese version of MoCA has shown good to excellent inter-rater (ICC=0.987, p<0.001) reliability in Chinese older adults.
Measured: 1 month follow-up (14 week)
Digit Span Test
The verbal short-term memory and working memory is measured by the digit span test. The subject was required to listen to a series of random numbers carefully and then repeated them in forward (forward digit span test) and backward (backward digit span test) order. Continue in the same manner by increasing the series of numbers. The difficulty will be increased when the number in a sequence increased. The forward digit span task requires verbal working memory and attention, while the backwards digit span task additionally tests cognitive control and executive function. The more correct trials performed indicated better short-term memory and work memory.
Measured: Baseline (0 week)
Digit Span Test
The verbal short-term memory and working memory is measured by the digit span test . The subject was required to listen to a series of random numbers carefully and then repeated them in forward (forward digit span test) and backward (backward digit span test) order. Continue in the same manner by increasing the series of numbers. The difficulty will be increased when the number in a sequence increased. The forward digit span task requires verbal working memory and attention, while the backwards digit span task additionally tests cognitive control and executive function.The more correct trials performed indicated better short-term memory and work memory.
Measured: Mid-intervention (5 week)
Digit Span Test
The verbal short-term memory and working memory is measured by the digit span test. The subject was required to listen to a series of random numbers carefully and then repeated them in forward (forward digit span test) and backward (backward digit span test) order. Continue in the same manner by increasing the series of numbers. The difficulty will be increased when the number in a sequence increased. The forward digit span task requires verbal working memory and attention, while the backwards digit span task additionally tests cognitive control and executive function.The more correct trials performed indicated better short-term memory and work memory.
Measured: Post-intervention (10 week)
Digit Span Test
The verbal short-term memory and working memory is measured by the digit span test . The subject was required to listen to a series of random numbers carefully and then repeated them in forward (forward digit span test) and backward (backward digit span test) order. Continue in the same manner by increasing the series of numbers. The difficulty will be increased when the number in a sequence increased. The forward digit span task requires verbal working memory and attention, while the backwards digit span task additionally tests cognitive control and executive function.The more correct trials performed indicated better short-term memory and work memory.
Measured: 1 month follow-up (14 week)
Visual Memory Span Test
The visual memory is measured by the visual memory span test. The subject was required to observe a given order to tap a number of block as shown by the examiners and then repeat them in forward and backward order. The difficulty will be increased when the number of blocks in a sequence increased. The more correct trials performed indicated better visual memory.
Measured: Baseline (0 week)
Visual Memory Span Test
The visual memory is measured by the visual memory span test. The subject was required to observe a given order to tap a number of block as shown by the examiners and then repeat them in forward and backward order. The difficulty will be increased when the number of blocks in a sequence increased. The more correct trials performed indicated better visual memory.
Measured: Mid-intervention (5 week)
Visual Memory Span Test
The visual memory is measured by the visual memory span test. The subject was required to observe a given order to tap a number of block as shown by the examiners and then repeat them in forward and backward order. The difficulty will be increased when the number of blocks in a sequence increased. The more correct trials performed indicated better visual memory.
Measured: Post-intervention (10 week)
Visual Memory Span Test
The visual memory is measured by the visual memory span test. The subject was required to observe a given order to tap a number of block as shown by the examiners and then repeat them in forward and backward order. The difficulty will be increased when the number of blocks in a sequence increased. The more correct trials performed indicated better visual memory.
Measured: 1 month follow-up (14 week)
Stroop Color and Word Test
The ability to inhibit cognitive interference is measured by the Stroop Color and Word Test. The Stroop Test consists of 3 subtasks. The first subtask shows color dots (green, blue, yellow, red) in random order. The second subtask shows the words (green, blue, red, yellow) in random order. The third task showed color words (green, blue, red, yellow) printed in a different ink color (i.e., the word blue printed in yellow ink). Participants are required to name the color of the ink as quickly as possible within 45 s in each task. The completion time and number of error is recorded in each task. The interference ratio of will be calculated as the completion time of the third task/the completion time of the first task. A higher interference score indicated poorer interference control.
Measured: Baseline (0 week)
Stroop Color and Word Test
The ability to inhibit cognitive interference is measured by the Stroop Color and Word Test. The Stroop Test consists of 3 subtasks. The first subtask shows color dots (green, blue, yellow, red) in random order. The second subtask shows the words (green, blue, red, yellow) in random order. The third task showed color words (green, blue, red, yellow) printed in a different ink color (i.e., the word blue printed in yellow ink). Participants are required to name the color of the ink as quickly as possible within 45 s in each task. The completion time and number of error is recorded in each task. The interference ratio of will be calculated as the completion time of the third task/the completion time of the first task. A higher interference score indicated poorer interference control.
Measured: Mid-intervention (5 week)
Stroop Color and Word Test
The ability to inhibit cognitive interference is measured by the Stroop Color and Word Test. The Stroop Test consists of 3 subtasks. The first subtask shows color dots (green, blue, yellow, red) in random order. The second subtask shows the words (green, blue, red, yellow) in random order. The third task showed color words (green, blue, red, yellow) printed in a different ink color (i.e., the word blue printed in yellow ink). Participants are required to name the color of the ink as quickly as possible within 45 s in each task. The completion time and number of error is recorded in each task. The interference ratio of will be calculated as the completion time of the third task/the completion time of the first task. A higher interference score indicated poorer interference control.
Measured: Post-intervention (10 week)
Stroop Color and Word Test
The ability to inhibit cognitive interference is measured by the Stroop Color and Word Test. The Stroop Test consists of 3 subtasks. The first subtask shows color dots (green, blue, yellow, red) in random order. The second subtask shows the words (green, blue, red, yellow) in random order. The third task showed color words (green, blue, red, yellow) printed in a different ink color (i.e., the word blue printed in yellow ink). Participants are required to name the color of the ink as quickly as possible within 45 s in each task. The completion time and number of error is recorded in each task. The interference ratio of will be calculated as the completion time of the third task/the completion time of the first task. A higher interference score indicated poorer interference control.
Measured: 1 month follow-up (14 week)
Face Recognition Test
The visual, nonverbal long-term memory is measured by the face recognition test from the Rivermead Behavioral Memory Test (RMBT). Fifteen faces are shown successively to the subject. After an occupied interval of 5 minutes, the subjects are required to select the original 15 faces from a set of 30. The recognition score is the number of correct answers minus the number of incorrect answers. The recognition score is ranged from -15 to 15. A higher score indicated a better visual, nonverbal long term memory.
Measured: Baseline (0 week)
Face Recognition Test
The visual, nonverbal long-term memory is measured by the face recognition test from the Rivermead Behavioral Memory Test (RMBT). Fifteen faces are shown successively to the subject. After an occupied interval of 5 minutes, the subjects are required to select the original 15 faces from a set of 30. The recognition score is the number of correct answers minus the number of incorrect answers. The recognition score is ranged from -15 to 15. A higher score indicated a better visual, nonverbal long term memory.
Measured: Mid-intervention (5 week)
Face Recognition Test
The visual, nonverbal long-term memory is measured by the face recognition test from the Rivermead Behavioral Memory Test (RMBT). Fifteen faces are shown successively to the subject. After an occupied interval of 5 minutes, the subjects are required to select the original 15 faces from a set of 30. The recognition score is the number of correct answers minus the number of incorrect answers. The recognition score is ranged from -15 to 15. A higher score indicated a better visual, nonverbal long term memory.
Measured: Post-intervention (10 week)
Face Recognition Test
The visual, nonverbal long-term memory is measured by the face recognition test from the Rivermead Behavioral Memory Test (RMBT). Fifteen faces are shown successively to the subject. After an occupied interval of 5 minutes, the subjects are required to select the original 15 faces from a set of 30. The recognition score is the number of correct answers minus the number of incorrect answers. The recognition score is ranged from -15 to 15. A higher score indicated a better visual, nonverbal long term memory.
Measured: 1 month follow-up (14 week)
Picture Recognition Test
The visual, verbal long-term memory is measured by the picture recognition test from the RBMT. Line drawings of 15 common objects are presented one at a time. After an occupied interval of 5 minutes, the subjects are asked to select the original 15 pictures from a set of 30. The recognition score is calculated in the same way as in the Face Recognition test. The recognition score is ranged from -15 to 15. A higher score indicated a better visual, verbal long term memory.
Measured: Baseline (0 week)
Picture Recognition Test
The visual, verbal long-term memory is measured by the picture recognition test from the RBMT. Line drawings of 15 common objects are presented one at a time. After an occupied interval of 5 minutes, the subjects are asked to select the original 15 pictures from a set of 30. The recognition score is calculated in the same way as in the Face Recognition test. The recognition score is ranged from -15 to 15. A higher score indicated a better visual, verbal long term memory.
Measured: Mid-intervention (5 week)
Picture Recognition Test
The visual, verbal long-term memory is measured by the picture recognition test from the RBMT. Line drawings of 15 common objects are presented one at a time. After an occupied interval of 5 minutes, the subjects are asked to select the original 15 pictures from a set of 30. The recognition score is calculated in the same way as in the Face Recognition test. The recognition score is ranged from -15 to 15. A higher score indicated a better visual, verbal long term memory.
Measured: Post-intervention (10 week)
Picture Recognition Test
The visual, verbal long-term memory is measured by the picture recognition test from the RBMT. Line drawings of 15 common objects are presented one at a time. After an occupied interval of 5 minutes, the subjects are asked to select the original 15 pictures from a set of 30. The recognition score is calculated in the same way as in the Face Recognition test. The recognition score is ranged from -15 to 15. A higher score indicated a better visual, verbal long term memory.
Measured: 1 month follow-up (14 week)
Berg Balance Scale (BBS)
The functional balance ability is measured by BBS. The BBS is an ordinal scale with 14 items, each item ranged from 0-4 with a total score ranged from 0-56. The higher score indicates a better balance function. Previous study has shown that BBS has good to excellent test-retest reliability (ICC=0.77-0.886) in older adults.
Measured: Baseline (0 week)
Berg Balance Scale (BBS)
The functional balance ability is measured by BBS. The BBS is an ordinal scale with 14 items, each item ranged from 0-4 with a total score ranged from 0-56. The higher score indicates a better balance function. Previous study has shown that BBS has good to excellent test-retest reliability (ICC=0.77-0.886) in older adults.
Measured: Mid-intervention (5 week)
Berg Balance Scale (BBS)
The functional balance ability is measured by BBS. The BBS is an ordinal scale with 14 items, each item ranged from 0-4 with a total score ranged from 0-56. The higher score indicates a better balance function. Previous study has shown that BBS has good to excellent test-retest reliability (ICC=0.77-0.886) in older adults.
Measured: Post-intervention (10 week)
Berg Balance Scale (BBS)
The functional balance ability is measured by BBS. The BBS is an ordinal scale with 14 items, each item ranged from 0-4 with a total score ranged from 0-56. The higher score indicates a better balance function. Previous study has shown that BBS has good to excellent test-retest reliability (ICC=0.77-0.886) in older adults.
Measured: 1 month follow-up (14 week)
10 Meter Walking Test (10MWT)
The walking speed over a short distance is measured by the 10MWT. The subject will be asked to walk 10 meter in a normal comfortable speed and maximum speed condition, respectively. The completion time will be records by stopwatch. Each condition will be repeated for 2 times. The completion time will be averaged. The shorter the completion time, the better performance is. 10MWT has shown excellent test-retest reliability (ICC=0.98) in assessing healthy older adults.
Measured: Baseline (0 week)
10 Meter Walking Test (10MWT)
The walking speed over a short distance is measured by the 10MWT. The subject will be asked to walk 10 meter in a normal comfortable speed and maximum speed condition, respectively. The completion time will be records by stopwatch. Each condition will be repeated for 2 times. The completion time will be averaged. The shorter the completion time, the better performance is. 10MWT has shown excellent test-retest reliability (ICC=0.98) in assessing healthy older adults.
Measured: Mid-intervention (5 week)
10 Meter Walking Test (10MWT)
The walking speed over a short distance is measured by the 10MWT. The subject will be asked to walk 10 meter in a normal comfortable speed and maximum speed condition, respectively. The completion time will be records by stopwatch. Each condition will be repeated for 2 times. The completion time will be averaged. The shorter the completion time, the better performance is. 10MWT has shown excellent test-retest reliability (ICC=0.98) in assessing healthy older adults.
Measured: Post-intervention (10 week)
10 Meter Walking Test (10MWT)
The walking speed over a short distance is measured by the 10MWT. The subject will be asked to walk 10 meter in a normal comfortable speed and maximum speed condition, respectively. The completion time will be records by stopwatch. Each condition will be repeated for 2 times. The completion time will be averaged. The shorter the completion time, the better performance is. 10MWT has shown excellent test-retest reliability (ICC=0.98) in assessing healthy older adults.
Measured: 1 month follow-up (14 week)
6 Minutes Walking Test (6MWT)
The aerobic capacity and walking endurance is measured by the 6MWT. The participants will be asked to walk as far as possible for 6 minutes in the 20 meters' corridor. The walking distance in 6 minutes will be records. The longer distance the subject walk, the better endurance is. The 6MWT has shown excellent test-retest reliability (ICC=0.95) in assessing healthy older adults.
Measured: Baseline (0 week)
6 Minutes Walking Test (6MWT)
The aerobic capacity and walking endurance is measured by the 6MWT. The participants will be asked to walk as far as possible for 6 minutes in the 20 meters' corridor. The walking distance in 6 minutes will be records. The longer distance the subject walk, the better endurance is. The 6MWT has shown excellent test-retest reliability (ICC=0.95) in assessing healthy older adults.
Measured: Mid-intervention (5 week)
6 Minutes Walking Test (6MWT)
The aerobic capacity and walking endurance is measured by the 6MWT. The participants will be asked to walk as far as possible for 6 minutes in the 20 meters' corridor. The walking distance in 6 minutes will be records. The longer distance the subject walk, the better endurance is. The 6MWT has shown excellent test-retest reliability (ICC=0.95) in assessing healthy older adults.
Measured: Post-intervention (10 week)
6 Minutes Walking Test (6MWT)
The aerobic capacity and walking endurance is measured by the 6MWT. The participants will be asked to walk as far as possible for 6 minutes in the 20 meters' corridor. The walking distance in 6 minutes will be records. The longer distance the subject walk, the better endurance is. The 6MWT has shown excellent test-retest reliability (ICC=0.95) in assessing healthy older adults.
Measured: 1 month follow-up (14 week)
Time Up and Go Test (TUG)
The functional ability is measured by TUG. The subject will be asked to stand up from the chair, walk 3 meters, turn 180°, go back to the chair and then sit down. The completion time will be recorded. The subjects need to repeat the test for 2 times. The completion time of the 2 trials will be averaged.
Measured: Baseline (0 week)
Time Up and Go Test (TUG)
The functional ability is measured by TUG. The subject will be asked to stand up from the chair, walk 3 meters, turn 180°, go back to the chair and then sit down. The completion time will be recorded. The subjects need to repeat the test for 2 times. The completion time of the 2 trials will be averaged.
Measured: Mid-intervention (5 week)
Time Up and Go Test (TUG)
The functional ability is measured by TUG. The subject will be asked to stand up from the chair, walk 3 meters, turn 180°, go back to the chair and then sit down. The completion time will be recorded. The subjects need to repeat the test for 2 times. The completion time of the 2 trials will be averaged.
Measured: Post-intervention (10 week)
Time Up and Go Test (TUG)
The functional ability is measured by TUG. The subject will be asked to stand up from the chair, walk 3 meters, turn 180°, go back to the chair and then sit down. The completion time will be recorded. The subjects need to repeat the test for 2 times. The completion time of the 2 trials will be averaged.
Measured: 1 month follow-up (14 week)
Community Integration Measure
The level of community integration is assessed by Chinese version of Community Integration Measure (CIM). It is a self-report questionnaire that is easily administrated to assess the community integration level. The instrument consists of 10 items, each rated from 1 to 5, giving a total score ranging from 10 to 50. A higher score indicates greater community integration. Liu et al. (Liu et al., 2014) reports that the Chinese version of the CIM showed good test-retest reliability (ICC=0.84) in people with stroke. A pilot study with 123 people with chronic stroke conducted as part of this research showed that CIM scores were significantly correlated with peak wrist flexion torque (r=0.203, p<0.05), Wolf Motoro Function Test (WMFT) scores (r=0.194, p<0.05) and Barthel Index scores (r=0.194, p<0.05).
Measured: Baseline (0 week)
Community Integration Measure
The level of community integration is assessed by Chinese version of Community Integration Measure (CIM). It is a self-report questionnaire that is easily administrated to assess the community integration level. The instrument consists of 10 items, each rated from 1 to 5, giving a total score ranging from 10 to 50. A higher score indicates greater community integration. Liu et al. reports that the Chinese version of the CIM showed good test-retest reliability (ICC=0.84) in people with stroke. A pilot study with 123 people with chronic stroke conducted as part of this research showed that CIM scores were significantly correlated with peak wrist flexion torque (r=0.203, p<0.05), WMFT scores (r=0.194, p<0.05) and Barthel Index scores (r=0.194, p<0.05).
Measured: Mid-intervention (5 week)
Community Integration Measure
The level of community integration is assessed by Chinese version of Community Integration Measure (CIM). It is a self-report questionnaire that is easily administrated to assess the community integration level. The instrument consists of 10 items, each rated from 1 to 5, giving a total score ranging from 10 to 50. A higher score indicates greater community integration. Liu et al. reports that the Chinese version of the CIM showed good test-retest reliability (ICC=0.84) in people with stroke. A pilot study with 123 people with chronic stroke conducted as part of this research showed that CIM scores were significantly correlated with peak wrist flexion torque (r=0.203, p<0.05), WMFT scores (r=0.194, p<0.05) and Barthel Index scores (r=0.194, p<0.05).
Measured: Post-intervention (10 week)
Community Integration Measure
The level of community integration is assessed by Chinese version of Community Integration Measure (CIM). It is a self-report questionnaire that is easily administrated to assess the community integration level. The instrument consists of 10 items, each rated from 1 to 5, giving a total score ranging from 10 to 50. A higher score indicates greater community integration. Liu et al. reports that the Chinese version of the CIM showed good test-retest reliability (ICC=0.84) in people with stroke. A pilot study with 123 people with chronic stroke conducted as part of this research showed that CIM scores were significantly correlated with peak wrist flexion torque (r=0.203, p<0.05), WMFT scores (r=0.194, p<0.05) and Barthel Index scores (r=0.194, p<0.05).
Measured: 1 month follow-up (14 week)
Limit of Stability (LOS)-Reaction Time
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Reaction time (RT) is used to assess the time participants take to give a movement response after cues are provided. The RT (second) in the 8 direction will be measured. The longer RT indicated poorer balance performance.
Measured: Baseline (0 week)
Limit of Stability (LOS)-Reaction Time
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Reaction time (RT) is used to assess the time participants take to give a movement response after cues are provided. The RT (second) in the 8 direction will be measured. The longer RT indicated poorer balance performance.
Measured: Mid-intervention (5 week)
Limit of Stability (LOS)-Reaction Time
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Reaction time (RT) is used to assess the time participants take to give a movement response after cues are provided. The RT (second) in the 8 direction will be measured. The longer RT indicated poorer balance performance.
Measured: Post-intervention (10 week)
Limit of Stability (LOS)-Reaction Time
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Reaction time (RT) is used to assess the time participants take to give a movement response after cues are provided. The RT (second) in the 8 direction will be measured. The longer RT indicated poorer balance performance.
Measured: 1 month follow-up (14 week)
Limit of Stability (LOS)-Movement Velocity
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Movement velocity (MV) is used to assess the average center of gravity (COG) displacement speed. The MV (degree/second) in the 8 direction will be measured. The smaller MV indicated poorer balance performance.
Measured: Baseline (0 week)
Limit of Stability (LOS)-Movement Velocity
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Movement velocity (MV) is used to assess the average center of gravity (COG) displacement speed. The MV (degree/second) in the 8 direction will be measured. The smaller MV indicated poorer balance performance.
Measured: Mid-intervention (5 week)
Limit of Stability (LOS)-Movement Velocity
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Movement velocity (MV) is used to assess the average center of gravity (COG) displacement speed. The MV (degree/second) in the 8 direction will be measured. The smaller MV indicated poorer balance performance.
Measured: Post-intervention (10 week)
Limit of Stability (LOS)-Movement Velocity
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Movement velocity (MV) is used to assess the average center of gravity (COG) displacement speed. The MV (degree/second) in the 8 direction will be measured. The smaller MV indicated poorer balance performance.
Measured: 1 month follow-up (14 week)
Limit of Stability (LOS)-Endpoint Excursion
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Endpoint excursion (EE) is used to assess how far the patient leans towards the target on his or her first attempt. The EE (%) in the 8 direction will be measured. The smaller EE indicated poorer balance performance.
Measured: Baseline (0 week)
Limit of Stability (LOS)-Endpoint Excursion
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Endpoint excursion (EE) is used to assess how far the patient leans towards the target on his or her first attempt. The EE (%) in the 8 direction will be measured. The smaller EE indicated poorer balance performance.
Measured: Mid-intervention (5 week)
Limit of Stability (LOS)-Endpoint Excursion
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Endpoint excursion (EE) is used to assess how far the patient leans towards the target on his or her first attempt. The EE (%) in the 8 direction will be measured. The smaller EE indicated poorer balance performance.
Measured: Post-intervention (10 week)
Limit of Stability (LOS)-Endpoint Excursion
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Endpoint excursion (EE) is used to assess how far the patient leans towards the target on his or her first attempt. The EE (%) in the 8 direction will be measured. The smaller EE indicated poorer balance performance.
Measured: 1 month follow-up (14 week)
Limit of Stability (LOS)-Maximum Excursion
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Maximum excursion (ME) is used to assess the maximum amount the patient leaned during the trial. The ME (%) in the 8 direction will be measured. The smaller ME indicated poorer balance performance.
Measured: Baseline (0 week)
Limit of Stability (LOS)-Maximum Excursion
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Maximum excursion (ME) is used to assess the maximum amount the patient leaned during the trial. The ME (%) in the 8 direction will be measured. The smaller ME indicated poorer balance performance.
Measured: Mid-intervention (5 week)
Limit of Stability (LOS)-Maximum Excursion
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Maximum excursion (ME) is used to assess the maximum amount the patient leaned during the trial. The ME (%) in the 8 direction will be measured. The smaller ME indicated poorer balance performance.
Measured: Post-intervention (10 week)
Limit of Stability (LOS)-Maximum Excursion
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Maximum excursion (ME) is used to assess the maximum amount the patient leaned during the trial. The ME (%) in the 8 direction will be measured. The smaller ME indicated poorer balance performance.
Measured: 1 month follow-up (14 week)
Limit of Stability (LOS)-Directional Control
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Directional control (DC) is used to assess how much of the patient's movement was in the target direction. The DC (%) in the 8 direction will be measured. The smaller DC indicated poorer balance performance.
Measured: Baseline (0 week)
Limit of Stability (LOS)-Directional Control
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Directional control (DC) is used to assess how much of the patient's movement was in the target direction. The DC (%) in the 8 direction will be measured. The smaller DC indicated poorer balance performance.
Measured: Mid-intervention (5 week)
Limit of Stability (LOS)-Directional Control
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Directional control (DC) is used to assess how much of the patient's movement was in the target direction. The DC (%) in the 8 direction will be measured. The smaller DC indicated poorer balance performance.
Measured: Post-intervention (10 week)
Limit of Stability (LOS)-Directional Control
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Directional control (DC) is used to assess how much of the patient's movement was in the target direction. The DC (%) in the 8 direction will be measured. The smaller DC indicated poorer balance performance.
Measured: 1 month follow-up (14 week)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 May 202223 Mar 2023

First posted7 Jun 2022
Study start23 May 2022
Primary completion23 Mar 2023
Study completion23 Mar 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (30)Papers the sponsor has linked to this study.
Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05408689
Sponsor's protocol ID: 2022_TVNS
Status last verified: Sep 2023
First submitted: 29 May 2022
Last updated: 22 Sep 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Albert MS, DeKosky ST, Dickson D, Dubois B, Feldman HH, Fox NC, Gamst A, Holtzman DM, Jagust WJ, Petersen RC, Snyder PJ, Carrillo MC, Thies B, Phelps CH. The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):270-9. doi: 10.1016/j.jalz.2011.03.008. Epub 2011 Apr 21.
PubMed 21514249
Alzheimer's Association. 2015 Alzheimer's disease facts and figures. Alzheimers Dement. 2015 Mar;11(3):332-84. doi: 10.1016/j.jalz.2015.02.003.
PubMed 25984581
Beste C, Steenbergen L, Sellaro R, Grigoriadou S, Zhang R, Chmielewski W, Stock AK, Colzato L. Effects of Concomitant Stimulation of the GABAergic and Norepinephrine System on Inhibitory Control - A Study Using Transcutaneous Vagus Nerve Stimulation. Brain Stimul. 2016 Nov-Dec;9(6):811-818. doi: 10.1016/j.brs.2016.07.004. Epub 2016 Jul 19.
PubMed 27522167
Burger AM, Verkuil B, Van Diest I, Van der Does W, Thayer JF, Brosschot JF. The effects of transcutaneous vagus nerve stimulation on conditioned fear extinction in humans. Neurobiol Learn Mem. 2016 Jul;132:49-56. doi: 10.1016/j.nlm.2016.05.007. Epub 2016 May 21.
PubMed 27222436
Elwood RW. The Wechsler Memory Scale-Revised: psychometric characteristics and clinical application. Neuropsychol Rev. 1991 Jun;2(2):179-201. doi: 10.1007/BF01109053.
PubMed 1844708
Gates NJ, Rutjes AW, Di Nisio M, Karim S, Chong LY, March E, Martinez G, Vernooij RW. Computerised cognitive training for 12 or more weeks for maintaining cognitive function in cognitively healthy people in late life. Cochrane Database Syst Rev. 2020 Feb 27;2(2):CD012277. doi: 10.1002/14651858.CD012277.pub3.
PubMed 32104914
Hein E, Nowak M, Kiess O, Biermann T, Bayerlein K, Kornhuber J, Kraus T. Auricular transcutaneous electrical nerve stimulation in depressed patients: a randomized controlled pilot study. J Neural Transm (Vienna). 2013 May;120(5):821-7. doi: 10.1007/s00702-012-0908-6. Epub 2012 Nov 2.
PubMed 23117749
Hiengkaew V, Jitaree K, Chaiyawat P. Minimal detectable changes of the Berg Balance Scale, Fugl-Meyer Assessment Scale, Timed "Up & Go" Test, gait speeds, and 2-minute walk test in individuals with chronic stroke with different degrees of ankle plantarflexor tone. Arch Phys Med Rehabil. 2012 Jul;93(7):1201-8. doi: 10.1016/j.apmr.2012.01.014. Epub 2012 Apr 12.
PubMed 22502805
Holbein-Jenny MA, Billek-Sawhney B, Beckman E, Smith T. Balance in personal care home residents: a comparison of the Berg Balance Scale, the Multi-Directional Reach Test, and the Activities-Specific Balance Confidence Scale. J Geriatr Phys Ther. 2005;28(2):48-53.
PubMed 16236228
Jansen WJ, Ossenkoppele R, Knol DL, Tijms BM, Scheltens P, Verhey FR, Visser PJ; Amyloid Biomarker Study Group; Aalten P, Aarsland D, Alcolea D, Alexander M, Almdahl IS, Arnold SE, Baldeiras I, Barthel H, van Berckel BN, Bibeau K, Blennow K, Brooks DJ, van Buchem MA, Camus V, Cavedo E, Chen K, Chetelat G, Cohen AD, Drzezga A, Engelborghs S, Fagan AM, Fladby T, Fleisher AS, van der Flier WM, Ford L, Forster S, Fortea J, Foskett N, Frederiksen KS, Freund-Levi Y, Frisoni GB, Froelich L, Gabryelewicz T, Gill KD, Gkatzima O, Gomez-Tortosa E, Gordon MF, Grimmer T, Hampel H, Hausner L, Hellwig S, Herukka SK, Hildebrandt H, Ishihara L, Ivanoiu A, Jagust WJ, Johannsen P, Kandimalla R, Kapaki E, Klimkowicz-Mrowiec A, Klunk WE, Kohler S, Koglin N, Kornhuber J, Kramberger MG, Van Laere K, Landau SM, Lee DY, de Leon M, Lisetti V, Lleo A, Madsen K, Maier W, Marcusson J, Mattsson N, de Mendonca A, Meulenbroek O, Meyer PT, Mintun MA, Mok V, Molinuevo JL, Mollergard HM, Morris JC, Mroczko B, Van der Mussele S, Na DL, Newberg A, Nordberg A, Nordlund A, Novak GP, Paraskevas GP, Parnetti L, Perera G, Peters O, Popp J, Prabhakar S, Rabinovici GD, Ramakers IH, Rami L, Resende de Oliveira C, Rinne JO, Rodrigue KM, Rodriguez-Rodriguez E, Roe CM, Rot U, Rowe CC, Ruther E, Sabri O, Sanchez-Juan P, Santana I, Sarazin M, Schroder J, Schutte C, Seo SW, Soetewey F, Soininen H, Spiru L, Struyfs H, Teunissen CE, Tsolaki M, Vandenberghe R, Verbeek MM, Villemagne VL, Vos SJ, van Waalwijk van Doorn LJ, Waldemar G, Wallin A, Wallin AK, Wiltfang J, Wolk DA, Zboch M, Zetterberg H. Prevalence of cerebral amyloid pathology in persons without dementia: a meta-analysis. JAMA. 2015 May 19;313(19):1924-38. doi: 10.1001/jama.2015.4668.
PubMed 25988462
Jonsdottir S, Bouma A, Sergeant JA, Scherder EJ. Effects of transcutaneous electrical nerve stimulation (TENS) on cognition, behavior, and the rest-activity rhythm in children with attention deficit hyperactivity disorder, combined type. Neurorehabil Neural Repair. 2004 Dec;18(4):212-21. doi: 10.1177/1545968304270759.
PubMed 15537992
Langa KM, Levine DA. The diagnosis and management of mild cognitive impairment: a clinical review. JAMA. 2014 Dec 17;312(23):2551-61. doi: 10.1001/jama.2014.13806.
PubMed 25514304
Liu TW, Ng SS, Ng GY. Translation and initial validation of the Chinese (Cantonese) version of community integration measure for use in patients with chronic stroke. Biomed Res Int. 2014;2014:623836. doi: 10.1155/2014/623836. Epub 2014 Jun 4.
PubMed 24995317
Luijpen MW, Swaab DF, Sergeant JA, van Dijk KR, Scherder EJ. Effects of transcutaneous electrical nerve stimulation (TENS) on memory in elderly with mild cognitive impairment. Behav Brain Res. 2005 Mar 30;158(2):349-57. doi: 10.1016/j.bbr.2004.09.017.
PubMed 15698902
Prince, M. J., Wimo, A., Guerchet, M. M., Ali, G. C., Wu, Y. T., & Prina, M. (2015). World Alzheimer Report 2015-The Global Impact of Dementia: An analysis of prevalence, incidence, cost and trends.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
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Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Clinical Trial of Transcutaneous Electrical Nerve Stimulation to Improve the Cognitive Functions in Older Adults
ClinicalTrials.gov ID: NCT05408689
Acronym / sponsor ID: 2022_TVNS
Conditions: Mild Cognitive Impairment
Keywords: Cognitive function, Transcutaneous electrical nerve stimulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: The Hong Kong Polytechnic UniversityUniversity, hospital or other
Study start: 23 May 2022 (actual)
Primary completion: 23 Mar 2023 (actual)
Study completion: 23 Mar 2023 (actual)
First posted: 7 Jun 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
T1 TENS	Experimental	Device: T1 TENSIn this study, participants will be treated 30 min per day, 3 days per week, for 10 consecutive weeks
Concha TENS	Experimental	Device: Concha TENSIn this study, participants will be treated 30 min per day, 3 days per week, for 10 consecutive weeks
Control	Placebo comparator	Device: ControlIn this study, participants will be treated 30 min per day, 3 days per week, for 10 consecutive weeks

Who may qualify

Ages: 55 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Concern regarding a change in cognition
Impairment in one or more cognitive domains
Preservation of independence in functional abilities
no signs of dementia were to be present and confirmed by the medical staff and medical records.

Key exclusion criteria (3 listed)

If their medical records reported a history of either psychiatric disorder, alcoholism, cerebral trauma, cerebrovascular disease, hydrocephalus, neoplasm, epilepsy, disturbances of consciousness, insulin-dependent diabetes mellitus or focal brain disorders;
Having active implants, such as cochlear implants, pacemaker;
Having wounds and diseased skin on the electrode position.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
T1 TENSThe subjects in Group A will received TENS (Burst mode, 9 pulses per burst, pulse frequency =160Hz, burst frequency=2Hz, intensity was set to trigger visible muscular twitches). Two 2 x 3 cm electrodes was attached on T1 level with 2 cm from the spine. Previous study has shown that it was effective to improve the cognitive function in subjects with Alzheimer's disease.	Device	T1 TENS
Concha TENSThe subjects in Group B will received TENS (25Hz, 0.5mA) on the concha of left outer ear. The electrical stimulation was generated by the portable neurostimulator (Nemos®, Cerbomed, Erlangen, Germany) and was delivered by a titanium electrodes positioning on top of a silicon earplug. Previous study has shown that it was effective to improve the Accelerate extinction memory formation and retention in healthy young adults.	Device	Concha TENS
ControlThe subjects in Group C will receive 30 min sham electrical stimulation on T1 by a placebo-TENS device. The Placebo-TENS was applied by an apparently identical TENS unit. The unit's power indicator light was illuminated, but the unit's electrical circuit had been manually disconnected inside. In order to shape the common mindset, all subjects (except those in the Control group) were informed that they might or might not feel an electrical current, as different stimulation parameters were being applied.	Device	Control

Primary outcome

Montreal cognitive assessment (MoCA)
Time frame: Baseline (0 week)
The overall cognitive function is measured by the Cantonese version of MoCA. The MoCA is a widely used 10-minute cognitive screening test for detection of MCI. The MoCA test includes 8 parts with a maximum score of 30. A higher score indicated a better cognitive function. The Cantonese version of MoCA has shown good to excellent inter-rater (ICC=0.987, p<0.001) reliability in Chinese older adults.
Montreal cognitive assessment (MoCA)
Time frame: Mid-intervention (5 week)
The overall cognitive function is measured by the Cantonese version of MoCA. The MoCA is a widely used 10-minute cognitive screening test for detection of MCI. The MoCA test includes 8 parts with a maximum score of 30. A higher score indicated a better cognitive function. The Cantonese version of MoCA has shown good to excellent inter-rater (ICC=0.987, p<0.001) reliability in Chinese older adults.
Montreal cognitive assessment (MoCA)
Time frame: Post-intervention (10 week)
The overall cognitive function is measured by the Cantonese version of MoCA. The MoCA is a widely used 10-minute cognitive screening test for detection of MCI. The MoCA test includes 8 parts with a maximum score of 30. A higher score indicated a better cognitive function. The Cantonese version of MoCA has shown good to excellent inter-rater (ICC=0.987, p<0.001) reliability in Chinese older adults.
Montreal cognitive assessment (MoCA)
Time frame: 1 month follow-up (14 week)
The overall cognitive function is measured by the Cantonese version of MoCA. The MoCA is a widely used 10-minute cognitive screening test for detection of MCI. The MoCA test includes 8 parts with a maximum score of 30. A higher score indicated a better cognitive function. The Cantonese version of MoCA has shown good to excellent inter-rater (ICC=0.987, p<0.001) reliability in Chinese older adults.
Digit Span Test
Time frame: Baseline (0 week)
The verbal short-term memory and working memory is measured by the digit span test. The subject was required to listen to a series of random numbers carefully and then repeated them in forward (forward digit span test) and backward (backward digit span test) order. Continue in the same manner by increasing the series of numbers. The difficulty will be increased when the number in a sequence increased. The forward digit span task requires verbal working memory and attention, while the backwards digit span task additionally tests cognitive control and executive function. The more correct trials performed indicated better short-term memory and work memory.
Digit Span Test
Time frame: Mid-intervention (5 week)
The verbal short-term memory and working memory is measured by the digit span test . The subject was required to listen to a series of random numbers carefully and then repeated them in forward (forward digit span test) and backward (backward digit span test) order. Continue in the same manner by increasing the series of numbers. The difficulty will be increased when the number in a sequence increased. The forward digit span task requires verbal working memory and attention, while the backwards digit span task additionally tests cognitive control and executive function.The more correct trials performed indicated better short-term memory and work memory.
Digit Span Test
Time frame: Post-intervention (10 week)
The verbal short-term memory and working memory is measured by the digit span test. The subject was required to listen to a series of random numbers carefully and then repeated them in forward (forward digit span test) and backward (backward digit span test) order. Continue in the same manner by increasing the series of numbers. The difficulty will be increased when the number in a sequence increased. The forward digit span task requires verbal working memory and attention, while the backwards digit span task additionally tests cognitive control and executive function.The more correct trials performed indicated better short-term memory and work memory.
Digit Span Test
Time frame: 1 month follow-up (14 week)
The verbal short-term memory and working memory is measured by the digit span test . The subject was required to listen to a series of random numbers carefully and then repeated them in forward (forward digit span test) and backward (backward digit span test) order. Continue in the same manner by increasing the series of numbers. The difficulty will be increased when the number in a sequence increased. The forward digit span task requires verbal working memory and attention, while the backwards digit span task additionally tests cognitive control and executive function.The more correct trials performed indicated better short-term memory and work memory.
Visual Memory Span Test
Time frame: Baseline (0 week)
The visual memory is measured by the visual memory span test. The subject was required to observe a given order to tap a number of block as shown by the examiners and then repeat them in forward and backward order. The difficulty will be increased when the number of blocks in a sequence increased. The more correct trials performed indicated better visual memory.
Visual Memory Span Test
Time frame: Mid-intervention (5 week)
The visual memory is measured by the visual memory span test. The subject was required to observe a given order to tap a number of block as shown by the examiners and then repeat them in forward and backward order. The difficulty will be increased when the number of blocks in a sequence increased. The more correct trials performed indicated better visual memory.
Visual Memory Span Test
Time frame: Post-intervention (10 week)
The visual memory is measured by the visual memory span test. The subject was required to observe a given order to tap a number of block as shown by the examiners and then repeat them in forward and backward order. The difficulty will be increased when the number of blocks in a sequence increased. The more correct trials performed indicated better visual memory.
Visual Memory Span Test
Time frame: 1 month follow-up (14 week)
The visual memory is measured by the visual memory span test. The subject was required to observe a given order to tap a number of block as shown by the examiners and then repeat them in forward and backward order. The difficulty will be increased when the number of blocks in a sequence increased. The more correct trials performed indicated better visual memory.
Stroop Color and Word Test
Time frame: Baseline (0 week)
The ability to inhibit cognitive interference is measured by the Stroop Color and Word Test. The Stroop Test consists of 3 subtasks. The first subtask shows color dots (green, blue, yellow, red) in random order. The second subtask shows the words (green, blue, red, yellow) in random order. The third task showed color words (green, blue, red, yellow) printed in a different ink color (i.e., the word blue printed in yellow ink). Participants are required to name the color of the ink as quickly as possible within 45 s in each task. The completion time and number of error is recorded in each task. The interference ratio of will be calculated as the completion time of the third task/the completion time of the first task. A higher interference score indicated poorer interference control.
Stroop Color and Word Test
Time frame: Mid-intervention (5 week)
The ability to inhibit cognitive interference is measured by the Stroop Color and Word Test. The Stroop Test consists of 3 subtasks. The first subtask shows color dots (green, blue, yellow, red) in random order. The second subtask shows the words (green, blue, red, yellow) in random order. The third task showed color words (green, blue, red, yellow) printed in a different ink color (i.e., the word blue printed in yellow ink). Participants are required to name the color of the ink as quickly as possible within 45 s in each task. The completion time and number of error is recorded in each task. The interference ratio of will be calculated as the completion time of the third task/the completion time of the first task. A higher interference score indicated poorer interference control.
Stroop Color and Word Test
Time frame: Post-intervention (10 week)
The ability to inhibit cognitive interference is measured by the Stroop Color and Word Test. The Stroop Test consists of 3 subtasks. The first subtask shows color dots (green, blue, yellow, red) in random order. The second subtask shows the words (green, blue, red, yellow) in random order. The third task showed color words (green, blue, red, yellow) printed in a different ink color (i.e., the word blue printed in yellow ink). Participants are required to name the color of the ink as quickly as possible within 45 s in each task. The completion time and number of error is recorded in each task. The interference ratio of will be calculated as the completion time of the third task/the completion time of the first task. A higher interference score indicated poorer interference control.
Stroop Color and Word Test
Time frame: 1 month follow-up (14 week)
The ability to inhibit cognitive interference is measured by the Stroop Color and Word Test. The Stroop Test consists of 3 subtasks. The first subtask shows color dots (green, blue, yellow, red) in random order. The second subtask shows the words (green, blue, red, yellow) in random order. The third task showed color words (green, blue, red, yellow) printed in a different ink color (i.e., the word blue printed in yellow ink). Participants are required to name the color of the ink as quickly as possible within 45 s in each task. The completion time and number of error is recorded in each task. The interference ratio of will be calculated as the completion time of the third task/the completion time of the first task. A higher interference score indicated poorer interference control.
Face Recognition Test
Time frame: Baseline (0 week)
The visual, nonverbal long-term memory is measured by the face recognition test from the Rivermead Behavioral Memory Test (RMBT). Fifteen faces are shown successively to the subject. After an occupied interval of 5 minutes, the subjects are required to select the original 15 faces from a set of 30. The recognition score is the number of correct answers minus the number of incorrect answers. The recognition score is ranged from -15 to 15. A higher score indicated a better visual, nonverbal long term memory.
Face Recognition Test
Time frame: Mid-intervention (5 week)
The visual, nonverbal long-term memory is measured by the face recognition test from the Rivermead Behavioral Memory Test (RMBT). Fifteen faces are shown successively to the subject. After an occupied interval of 5 minutes, the subjects are required to select the original 15 faces from a set of 30. The recognition score is the number of correct answers minus the number of incorrect answers. The recognition score is ranged from -15 to 15. A higher score indicated a better visual, nonverbal long term memory.
Face Recognition Test
Time frame: Post-intervention (10 week)
The visual, nonverbal long-term memory is measured by the face recognition test from the Rivermead Behavioral Memory Test (RMBT). Fifteen faces are shown successively to the subject. After an occupied interval of 5 minutes, the subjects are required to select the original 15 faces from a set of 30. The recognition score is the number of correct answers minus the number of incorrect answers. The recognition score is ranged from -15 to 15. A higher score indicated a better visual, nonverbal long term memory.
Face Recognition Test
Time frame: 1 month follow-up (14 week)
The visual, nonverbal long-term memory is measured by the face recognition test from the Rivermead Behavioral Memory Test (RMBT). Fifteen faces are shown successively to the subject. After an occupied interval of 5 minutes, the subjects are required to select the original 15 faces from a set of 30. The recognition score is the number of correct answers minus the number of incorrect answers. The recognition score is ranged from -15 to 15. A higher score indicated a better visual, nonverbal long term memory.
Picture Recognition Test
Time frame: Baseline (0 week)
The visual, verbal long-term memory is measured by the picture recognition test from the RBMT. Line drawings of 15 common objects are presented one at a time. After an occupied interval of 5 minutes, the subjects are asked to select the original 15 pictures from a set of 30. The recognition score is calculated in the same way as in the Face Recognition test. The recognition score is ranged from -15 to 15. A higher score indicated a better visual, verbal long term memory.
Picture Recognition Test
Time frame: Mid-intervention (5 week)
The visual, verbal long-term memory is measured by the picture recognition test from the RBMT. Line drawings of 15 common objects are presented one at a time. After an occupied interval of 5 minutes, the subjects are asked to select the original 15 pictures from a set of 30. The recognition score is calculated in the same way as in the Face Recognition test. The recognition score is ranged from -15 to 15. A higher score indicated a better visual, verbal long term memory.
Picture Recognition Test
Time frame: Post-intervention (10 week)
The visual, verbal long-term memory is measured by the picture recognition test from the RBMT. Line drawings of 15 common objects are presented one at a time. After an occupied interval of 5 minutes, the subjects are asked to select the original 15 pictures from a set of 30. The recognition score is calculated in the same way as in the Face Recognition test. The recognition score is ranged from -15 to 15. A higher score indicated a better visual, verbal long term memory.
Picture Recognition Test
Time frame: 1 month follow-up (14 week)
The visual, verbal long-term memory is measured by the picture recognition test from the RBMT. Line drawings of 15 common objects are presented one at a time. After an occupied interval of 5 minutes, the subjects are asked to select the original 15 pictures from a set of 30. The recognition score is calculated in the same way as in the Face Recognition test. The recognition score is ranged from -15 to 15. A higher score indicated a better visual, verbal long term memory.
Berg Balance Scale (BBS)
Time frame: Baseline (0 week)
The functional balance ability is measured by BBS. The BBS is an ordinal scale with 14 items, each item ranged from 0-4 with a total score ranged from 0-56. The higher score indicates a better balance function. Previous study has shown that BBS has good to excellent test-retest reliability (ICC=0.77-0.886) in older adults.
Berg Balance Scale (BBS)
Time frame: Mid-intervention (5 week)
The functional balance ability is measured by BBS. The BBS is an ordinal scale with 14 items, each item ranged from 0-4 with a total score ranged from 0-56. The higher score indicates a better balance function. Previous study has shown that BBS has good to excellent test-retest reliability (ICC=0.77-0.886) in older adults.
Berg Balance Scale (BBS)
Time frame: Post-intervention (10 week)
The functional balance ability is measured by BBS. The BBS is an ordinal scale with 14 items, each item ranged from 0-4 with a total score ranged from 0-56. The higher score indicates a better balance function. Previous study has shown that BBS has good to excellent test-retest reliability (ICC=0.77-0.886) in older adults.
Berg Balance Scale (BBS)
Time frame: 1 month follow-up (14 week)
The functional balance ability is measured by BBS. The BBS is an ordinal scale with 14 items, each item ranged from 0-4 with a total score ranged from 0-56. The higher score indicates a better balance function. Previous study has shown that BBS has good to excellent test-retest reliability (ICC=0.77-0.886) in older adults.
10 Meter Walking Test (10MWT)
Time frame: Baseline (0 week)
The walking speed over a short distance is measured by the 10MWT. The subject will be asked to walk 10 meter in a normal comfortable speed and maximum speed condition, respectively. The completion time will be records by stopwatch. Each condition will be repeated for 2 times. The completion time will be averaged. The shorter the completion time, the better performance is. 10MWT has shown excellent test-retest reliability (ICC=0.98) in assessing healthy older adults.
10 Meter Walking Test (10MWT)
Time frame: Mid-intervention (5 week)
The walking speed over a short distance is measured by the 10MWT. The subject will be asked to walk 10 meter in a normal comfortable speed and maximum speed condition, respectively. The completion time will be records by stopwatch. Each condition will be repeated for 2 times. The completion time will be averaged. The shorter the completion time, the better performance is. 10MWT has shown excellent test-retest reliability (ICC=0.98) in assessing healthy older adults.
10 Meter Walking Test (10MWT)
Time frame: Post-intervention (10 week)
The walking speed over a short distance is measured by the 10MWT. The subject will be asked to walk 10 meter in a normal comfortable speed and maximum speed condition, respectively. The completion time will be records by stopwatch. Each condition will be repeated for 2 times. The completion time will be averaged. The shorter the completion time, the better performance is. 10MWT has shown excellent test-retest reliability (ICC=0.98) in assessing healthy older adults.
10 Meter Walking Test (10MWT)
Time frame: 1 month follow-up (14 week)
The walking speed over a short distance is measured by the 10MWT. The subject will be asked to walk 10 meter in a normal comfortable speed and maximum speed condition, respectively. The completion time will be records by stopwatch. Each condition will be repeated for 2 times. The completion time will be averaged. The shorter the completion time, the better performance is. 10MWT has shown excellent test-retest reliability (ICC=0.98) in assessing healthy older adults.
6 Minutes Walking Test (6MWT)
Time frame: Baseline (0 week)
The aerobic capacity and walking endurance is measured by the 6MWT. The participants will be asked to walk as far as possible for 6 minutes in the 20 meters' corridor. The walking distance in 6 minutes will be records. The longer distance the subject walk, the better endurance is. The 6MWT has shown excellent test-retest reliability (ICC=0.95) in assessing healthy older adults.
6 Minutes Walking Test (6MWT)
Time frame: Mid-intervention (5 week)
The aerobic capacity and walking endurance is measured by the 6MWT. The participants will be asked to walk as far as possible for 6 minutes in the 20 meters' corridor. The walking distance in 6 minutes will be records. The longer distance the subject walk, the better endurance is. The 6MWT has shown excellent test-retest reliability (ICC=0.95) in assessing healthy older adults.
6 Minutes Walking Test (6MWT)
Time frame: Post-intervention (10 week)
The aerobic capacity and walking endurance is measured by the 6MWT. The participants will be asked to walk as far as possible for 6 minutes in the 20 meters' corridor. The walking distance in 6 minutes will be records. The longer distance the subject walk, the better endurance is. The 6MWT has shown excellent test-retest reliability (ICC=0.95) in assessing healthy older adults.
6 Minutes Walking Test (6MWT)
Time frame: 1 month follow-up (14 week)
The aerobic capacity and walking endurance is measured by the 6MWT. The participants will be asked to walk as far as possible for 6 minutes in the 20 meters' corridor. The walking distance in 6 minutes will be records. The longer distance the subject walk, the better endurance is. The 6MWT has shown excellent test-retest reliability (ICC=0.95) in assessing healthy older adults.
Time Up and Go Test (TUG)
Time frame: Baseline (0 week)
The functional ability is measured by TUG. The subject will be asked to stand up from the chair, walk 3 meters, turn 180°, go back to the chair and then sit down. The completion time will be recorded. The subjects need to repeat the test for 2 times. The completion time of the 2 trials will be averaged.
Time Up and Go Test (TUG)
Time frame: Mid-intervention (5 week)
The functional ability is measured by TUG. The subject will be asked to stand up from the chair, walk 3 meters, turn 180°, go back to the chair and then sit down. The completion time will be recorded. The subjects need to repeat the test for 2 times. The completion time of the 2 trials will be averaged.
Time Up and Go Test (TUG)
Time frame: Post-intervention (10 week)
The functional ability is measured by TUG. The subject will be asked to stand up from the chair, walk 3 meters, turn 180°, go back to the chair and then sit down. The completion time will be recorded. The subjects need to repeat the test for 2 times. The completion time of the 2 trials will be averaged.
Time Up and Go Test (TUG)
Time frame: 1 month follow-up (14 week)
The functional ability is measured by TUG. The subject will be asked to stand up from the chair, walk 3 meters, turn 180°, go back to the chair and then sit down. The completion time will be recorded. The subjects need to repeat the test for 2 times. The completion time of the 2 trials will be averaged.
Community Integration Measure
Time frame: Baseline (0 week)
The level of community integration is assessed by Chinese version of Community Integration Measure (CIM). It is a self-report questionnaire that is easily administrated to assess the community integration level. The instrument consists of 10 items, each rated from 1 to 5, giving a total score ranging from 10 to 50. A higher score indicates greater community integration. Liu et al. (Liu et al., 2014) reports that the Chinese version of the CIM showed good test-retest reliability (ICC=0.84) in people with stroke. A pilot study with 123 people with chronic stroke conducted as part of this research showed that CIM scores were significantly correlated with peak wrist flexion torque (r=0.203, p<0.05), Wolf Motoro Function Test (WMFT) scores (r=0.194, p<0.05) and Barthel Index scores (r=0.194, p<0.05).
Community Integration Measure
Time frame: Mid-intervention (5 week)
The level of community integration is assessed by Chinese version of Community Integration Measure (CIM). It is a self-report questionnaire that is easily administrated to assess the community integration level. The instrument consists of 10 items, each rated from 1 to 5, giving a total score ranging from 10 to 50. A higher score indicates greater community integration. Liu et al. reports that the Chinese version of the CIM showed good test-retest reliability (ICC=0.84) in people with stroke. A pilot study with 123 people with chronic stroke conducted as part of this research showed that CIM scores were significantly correlated with peak wrist flexion torque (r=0.203, p<0.05), WMFT scores (r=0.194, p<0.05) and Barthel Index scores (r=0.194, p<0.05).
Community Integration Measure
Time frame: Post-intervention (10 week)
The level of community integration is assessed by Chinese version of Community Integration Measure (CIM). It is a self-report questionnaire that is easily administrated to assess the community integration level. The instrument consists of 10 items, each rated from 1 to 5, giving a total score ranging from 10 to 50. A higher score indicates greater community integration. Liu et al. reports that the Chinese version of the CIM showed good test-retest reliability (ICC=0.84) in people with stroke. A pilot study with 123 people with chronic stroke conducted as part of this research showed that CIM scores were significantly correlated with peak wrist flexion torque (r=0.203, p<0.05), WMFT scores (r=0.194, p<0.05) and Barthel Index scores (r=0.194, p<0.05).
Community Integration Measure
Time frame: 1 month follow-up (14 week)
The level of community integration is assessed by Chinese version of Community Integration Measure (CIM). It is a self-report questionnaire that is easily administrated to assess the community integration level. The instrument consists of 10 items, each rated from 1 to 5, giving a total score ranging from 10 to 50. A higher score indicates greater community integration. Liu et al. reports that the Chinese version of the CIM showed good test-retest reliability (ICC=0.84) in people with stroke. A pilot study with 123 people with chronic stroke conducted as part of this research showed that CIM scores were significantly correlated with peak wrist flexion torque (r=0.203, p<0.05), WMFT scores (r=0.194, p<0.05) and Barthel Index scores (r=0.194, p<0.05).
Limit of Stability (LOS)-Reaction Time
Time frame: Baseline (0 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Reaction time (RT) is used to assess the time participants take to give a movement response after cues are provided. The RT (second) in the 8 direction will be measured. The longer RT indicated poorer balance performance.
Limit of Stability (LOS)-Reaction Time
Time frame: Mid-intervention (5 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Reaction time (RT) is used to assess the time participants take to give a movement response after cues are provided. The RT (second) in the 8 direction will be measured. The longer RT indicated poorer balance performance.
Limit of Stability (LOS)-Reaction Time
Time frame: Post-intervention (10 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Reaction time (RT) is used to assess the time participants take to give a movement response after cues are provided. The RT (second) in the 8 direction will be measured. The longer RT indicated poorer balance performance.
Limit of Stability (LOS)-Reaction Time
Time frame: 1 month follow-up (14 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Reaction time (RT) is used to assess the time participants take to give a movement response after cues are provided. The RT (second) in the 8 direction will be measured. The longer RT indicated poorer balance performance.
Limit of Stability (LOS)-Movement Velocity
Time frame: Baseline (0 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Movement velocity (MV) is used to assess the average center of gravity (COG) displacement speed. The MV (degree/second) in the 8 direction will be measured. The smaller MV indicated poorer balance performance.
Limit of Stability (LOS)-Movement Velocity
Time frame: Mid-intervention (5 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Movement velocity (MV) is used to assess the average center of gravity (COG) displacement speed. The MV (degree/second) in the 8 direction will be measured. The smaller MV indicated poorer balance performance.
Limit of Stability (LOS)-Movement Velocity
Time frame: Post-intervention (10 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Movement velocity (MV) is used to assess the average center of gravity (COG) displacement speed. The MV (degree/second) in the 8 direction will be measured. The smaller MV indicated poorer balance performance.
Limit of Stability (LOS)-Movement Velocity
Time frame: 1 month follow-up (14 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Movement velocity (MV) is used to assess the average center of gravity (COG) displacement speed. The MV (degree/second) in the 8 direction will be measured. The smaller MV indicated poorer balance performance.
Limit of Stability (LOS)-Endpoint Excursion
Time frame: Baseline (0 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Endpoint excursion (EE) is used to assess how far the patient leans towards the target on his or her first attempt. The EE (%) in the 8 direction will be measured. The smaller EE indicated poorer balance performance.
Limit of Stability (LOS)-Endpoint Excursion
Time frame: Mid-intervention (5 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Endpoint excursion (EE) is used to assess how far the patient leans towards the target on his or her first attempt. The EE (%) in the 8 direction will be measured. The smaller EE indicated poorer balance performance.
Limit of Stability (LOS)-Endpoint Excursion
Time frame: Post-intervention (10 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Endpoint excursion (EE) is used to assess how far the patient leans towards the target on his or her first attempt. The EE (%) in the 8 direction will be measured. The smaller EE indicated poorer balance performance.
Limit of Stability (LOS)-Endpoint Excursion
Time frame: 1 month follow-up (14 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Endpoint excursion (EE) is used to assess how far the patient leans towards the target on his or her first attempt. The EE (%) in the 8 direction will be measured. The smaller EE indicated poorer balance performance.
Limit of Stability (LOS)-Maximum Excursion
Time frame: Baseline (0 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Maximum excursion (ME) is used to assess the maximum amount the patient leaned during the trial. The ME (%) in the 8 direction will be measured. The smaller ME indicated poorer balance performance.
Limit of Stability (LOS)-Maximum Excursion
Time frame: Mid-intervention (5 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Maximum excursion (ME) is used to assess the maximum amount the patient leaned during the trial. The ME (%) in the 8 direction will be measured. The smaller ME indicated poorer balance performance.
Limit of Stability (LOS)-Maximum Excursion
Time frame: Post-intervention (10 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Maximum excursion (ME) is used to assess the maximum amount the patient leaned during the trial. The ME (%) in the 8 direction will be measured. The smaller ME indicated poorer balance performance.
Limit of Stability (LOS)-Maximum Excursion
Time frame: 1 month follow-up (14 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Maximum excursion (ME) is used to assess the maximum amount the patient leaned during the trial. The ME (%) in the 8 direction will be measured. The smaller ME indicated poorer balance performance.
Limit of Stability (LOS)-Directional Control
Time frame: Baseline (0 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Directional control (DC) is used to assess how much of the patient's movement was in the target direction. The DC (%) in the 8 direction will be measured. The smaller DC indicated poorer balance performance.
Limit of Stability (LOS)-Directional Control
Time frame: Mid-intervention (5 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Directional control (DC) is used to assess how much of the patient's movement was in the target direction. The DC (%) in the 8 direction will be measured. The smaller DC indicated poorer balance performance.
Limit of Stability (LOS)-Directional Control
Time frame: Post-intervention (10 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Directional control (DC) is used to assess how much of the patient's movement was in the target direction. The DC (%) in the 8 direction will be measured. The smaller DC indicated poorer balance performance.
Limit of Stability (LOS)-Directional Control
Time frame: 1 month follow-up (14 week)
The LOS is measured by the balance plate system (Bertec, Columbus, OH). During the limits of stability task, subjects were instructed to shift their weight by moving their pelvis and torso without flexing their hips or knees, keeping their heels in contact with the force plates and their arms/hands at their sides. The subjects will be instructed to shifted his or her center of mass to forward (0°), right-forward (45°), right (90°), right-backward (135°), backward (180°), left backward (225°), left (270°) and left-forward (315°), based on a visual projection of the center of mass in the current and target locations. The duration of each weight shifting trial was 10 seconds. Directional control (DC) is used to assess how much of the patient's movement was in the target direction. The DC (%) in the 8 direction will be measured. The smaller DC indicated poorer balance performance.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
Background: PubMed 21514249Albert MS, DeKosky ST, Dickson D, Dubois B, Feldman HH, Fox NC, Gamst A, Holtzman DM, Jagust WJ, Petersen RC, Snyder PJ, Carrillo MC, Thies B, Phelps CH. The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):270-9. doi: 10.1016/j.jalz.2011.03.008. Epub 2011 Apr 21.
Background: PubMed 25984581Alzheimer's Association. 2015 Alzheimer's disease facts and figures. Alzheimers Dement. 2015 Mar;11(3):332-84. doi: 10.1016/j.jalz.2015.02.003.
Background: PubMed 27522167Beste C, Steenbergen L, Sellaro R, Grigoriadou S, Zhang R, Chmielewski W, Stock AK, Colzato L. Effects of Concomitant Stimulation of the GABAergic and Norepinephrine System on Inhibitory Control - A Study Using Transcutaneous Vagus Nerve Stimulation. Brain Stimul. 2016 Nov-Dec;9(6):811-818. doi: 10.1016/j.brs.2016.07.004. Epub 2016 Jul 19.
Background: PubMed 27222436Burger AM, Verkuil B, Van Diest I, Van der Does W, Thayer JF, Brosschot JF. The effects of transcutaneous vagus nerve stimulation on conditioned fear extinction in humans. Neurobiol Learn Mem. 2016 Jul;132:49-56. doi: 10.1016/j.nlm.2016.05.007. Epub 2016 May 21.
Background: PubMed 1844708Elwood RW. The Wechsler Memory Scale-Revised: psychometric characteristics and clinical application. Neuropsychol Rev. 1991 Jun;2(2):179-201. doi: 10.1007/BF01109053.
Background: PubMed 32104914Gates NJ, Rutjes AW, Di Nisio M, Karim S, Chong LY, March E, Martinez G, Vernooij RW. Computerised cognitive training for 12 or more weeks for maintaining cognitive function in cognitively healthy people in late life. Cochrane Database Syst Rev. 2020 Feb 27;2(2):CD012277. doi: 10.1002/14651858.CD012277.pub3.
Background: PubMed 23117749Hein E, Nowak M, Kiess O, Biermann T, Bayerlein K, Kornhuber J, Kraus T. Auricular transcutaneous electrical nerve stimulation in depressed patients: a randomized controlled pilot study. J Neural Transm (Vienna). 2013 May;120(5):821-7. doi: 10.1007/s00702-012-0908-6. Epub 2012 Nov 2.
Background: PubMed 22502805Hiengkaew V, Jitaree K, Chaiyawat P. Minimal detectable changes of the Berg Balance Scale, Fugl-Meyer Assessment Scale, Timed "Up & Go" Test, gait speeds, and 2-minute walk test in individuals with chronic stroke with different degrees of ankle plantarflexor tone. Arch Phys Med Rehabil. 2012 Jul;93(7):1201-8. doi: 10.1016/j.apmr.2012.01.014. Epub 2012 Apr 12.
Background: PubMed 16236228Holbein-Jenny MA, Billek-Sawhney B, Beckman E, Smith T. Balance in personal care home residents: a comparison of the Berg Balance Scale, the Multi-Directional Reach Test, and the Activities-Specific Balance Confidence Scale. J Geriatr Phys Ther. 2005;28(2):48-53.
Background: PubMed 25988462Jansen WJ, Ossenkoppele R, Knol DL, Tijms BM, Scheltens P, Verhey FR, Visser PJ; Amyloid Biomarker Study Group; Aalten P, Aarsland D, Alcolea D, Alexander M, Almdahl IS, Arnold SE, Baldeiras I, Barthel H, van Berckel BN, Bibeau K, Blennow K, Brooks DJ, van Buchem MA, Camus V, Cavedo E, Chen K, Chetelat G, Cohen AD, Drzezga A, Engelborghs S, Fagan AM, Fladby T, Fleisher AS, van der Flier WM, Ford L, Forster S, Fortea J, Foskett N, Frederiksen KS, Freund-Levi Y, Frisoni GB, Froelich L, Gabryelewicz T, Gill KD, Gkatzima O, Gomez-Tortosa E, Gordon MF, Grimmer T, Hampel H, Hausner L, Hellwig S, Herukka SK, Hildebrandt H, Ishihara L, Ivanoiu A, Jagust WJ, Johannsen P, Kandimalla R, Kapaki E, Klimkowicz-Mrowiec A, Klunk WE, Kohler S, Koglin N, Kornhuber J, Kramberger MG, Van Laere K, Landau SM, Lee DY, de Leon M, Lisetti V, Lleo A, Madsen K, Maier W, Marcusson J, Mattsson N, de Mendonca A, Meulenbroek O, Meyer PT, Mintun MA, Mok V, Molinuevo JL, Mollergard HM, Morris JC, Mroczko B, Van der Mussele S, Na DL, Newberg A, Nordberg A, Nordlund A, Novak GP, Paraskevas GP, Parnetti L, Perera G, Peters O, Popp J, Prabhakar S, Rabinovici GD, Ramakers IH, Rami L, Resende de Oliveira C, Rinne JO, Rodrigue KM, Rodriguez-Rodriguez E, Roe CM, Rot U, Rowe CC, Ruther E, Sabri O, Sanchez-Juan P, Santana I, Sarazin M, Schroder J, Schutte C, Seo SW, Soetewey F, Soininen H, Spiru L, Struyfs H, Teunissen CE, Tsolaki M, Vandenberghe R, Verbeek MM, Villemagne VL, Vos SJ, van Waalwijk van Doorn LJ, Waldemar G, Wallin A, Wallin AK, Wiltfang J, Wolk DA, Zboch M, Zetterberg H. Prevalence of cerebral amyloid pathology in persons without dementia: a meta-analysis. JAMA. 2015 May 19;313(19):1924-38. doi: 10.1001/jama.2015.4668.
Background: PubMed 15537992Jonsdottir S, Bouma A, Sergeant JA, Scherder EJ. Effects of transcutaneous electrical nerve stimulation (TENS) on cognition, behavior, and the rest-activity rhythm in children with attention deficit hyperactivity disorder, combined type. Neurorehabil Neural Repair. 2004 Dec;18(4):212-21. doi: 10.1177/1545968304270759.
Background: PubMed 25514304Langa KM, Levine DA. The diagnosis and management of mild cognitive impairment: a clinical review. JAMA. 2014 Dec 17;312(23):2551-61. doi: 10.1001/jama.2014.13806.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shamay Ng, PhD principal investigator

The Hong Kong Polytechnic University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing T1 TENS and Concha TENS in people with Mild Cognitive Impairment, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Montreal cognitive assessment (MoCA) (time frame: Baseline (0 week)). The study lists 64 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05408689, which also lists 30 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.