DementiaNCT03614962
Warmth and Transcutaneous Electrical Nerve Stimulation (TENS) in Improving Cognitive Functions in People with Dementia
A study testing Warmth + TENS, TENS and Warmth only in people with Dementia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
Evidence showed that both TENS and passive body heating are potential treatment strategies for improving cognitive functions in people with dementia. It is hypothesized that hat device (Warmth +TENS) over the 4 acupuncture points would induce a greater improvement in cognitive functions and behavioural symptoms when… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Warmth + TENS, TENS and Warmth only
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Mar 2019to 2 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- are currently diagnosed having Alzheimer's disease, vascular dementia or mixed-type mild to major neurocognitive disorder based on the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM -5) by psychogeriatrician with more than 3 years of experience in dementia diagnosis;
- are categorized in the mild or moderate degree of dementia based on the Global Deterioration Scale;
- have a stable drug intake for the past 3 months;
- live with at least 1 caregiver in the community;
- are able to follow simple instructions;
- are able to give informed consent by them or their family members.
Who cannot join
- have unstable medical conditions or severe behavioural disturbances, which do not allow participation in the study as judged by the study psychogeriatrician,
- have any additional medical, cardiovascular , orthopedic or cognitive conditions, such as having uncontrolled hypertension unstable angina and comorbid schizophrenia, that would hinder proper assessment and treatment.
- use a cardiac pacemaker,
- live in old age home, elderly home or care and attention homes,
- receive long term nursing home placements of patients during the treatment phase
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hong Kong
Shamay Ng, Dr, 27664883
About this study
Official title: Efficacy of Warmth and Transcutaneous Electrical Nerve Stimulation (TENS) in Improving Cognitive Functions and Behavioral Symptoms in Older Adults with Dementia: a Randomized, Controlled Clinical Trial
Evidence showed that both TENS and passive body heating are potential treatment strategies for improving cognitive functions in people with dementia. It is hypothesized that hat device (Warmth +TENS) over the 4 acupuncture points would induce a greater improvement in cognitive functions and behavioural symptoms when compared with other hat devices (Warmth + placebo-TENS; TENS only; Warmth alone) and Control (hat device with no warmth and no TENS).
Read the detailed description
Acupuncture, a primary therapeutic method in traditional Chinese medicine, has been used for patients with dementia to improve memory, orientation, calculation, and self-managing ability in patients having dementia and prevent decline of cognitive functions. Results of animal studies have demonstrated that electroacupuncture on the head region is effective in managing the symptoms associated with dementia, including vascular dementia.
A review of 8 studies on effects of TENS on non-pain related cognitive and behavioural functioning in patients with Alzheimer's disease and non-demented patients concluded that TENS could improve memory, affective behaviour and rest-activity rhythm in patients having Alzheimer's disease.
Passive body heating is another novel physical intervention strategy which potentially can relieve the symptoms of dementia. A previous study demonstrated that the attention function of 15 elderly, measured by the reaction time in the Rapid Visual Processing Test, improved after passive body heating via a thermal suit. Moreover, 30 minutes of hot-water immersion improved the sleep quality in 13 people with vascular dementia.
- Conditions
- Dementia
- Being tested
- Warmth + TENS, Warmth + placebo-TENS, TENS, Warmth only, control
- Keywords
- Transcutaneous electrical nerve stimulation, Cognitive, Memory
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Warmth + TENSDevice
A hat device will offer the electrical stimulation (pulse width of 120 milliseconds at about 100 Hz with constant current 0.02mA-0.7 mA, intensity setting at sensory threshold) over 4 acupuncture points over the scalp, including Baihui (GV20), Sishencong (EX-HN1), Fengchi (GB20) and Shenting (GV24). Selection of acupuncture points has been based on the recommendation of traditional Chinese medicine.
A custom-built warmth pad surrounding the TENS electrodes could produce the controlled comfortable warmth sensation, with default setting at 37degrees to 40 degrees Celsius.
Warmth + placebo-TENSDevice
A custom-built warmth pad surrounding the TENS electrodes could produce the controlled comfortable warmth sensation, with default setting at 37degrees to 40 degrees Celsius. The TENS electrodes are presented in the cap but no output will be delivered via these electrodes.
TENSDevice
A hat device will offer the electrical stimulation (pulse width of 120 milliseconds at about 100 Hz with constant current 0.02mA-0.7 mA, intensity setting at sensory threshold) over 4 acupuncture points over the scalp, including Baihui (GV20), Sishencong (EX-HN1), Fengchi (GB20) and Shenting (GV24). Selection of acupuncture points has been based on the recommendation of traditional Chinese medicine.
Warmth onlyDevice
A custom-built warmth pad surrounding the TENS electrodes could produce the controlled comfortable warmth sensation, with default setting at 37degrees to 40 degrees Celsius. No built-in TENS electrodes in the cap.
controlDevice
No warmth pad and TENS electrodes presented in the cap.
| Study group | Role | What they receive |
|---|---|---|
| Warmth + TENS group | Experimental | All participants will be offered a hat device that elicits warmth and TENS. Receives: Device: Warmth + TENS |
| Warmth + placebo-TENS group | Active comparator | All participants will be offered a hat device that elicits warmth and placebo-TENS. Receives: Device: Warmth + placebo-TENS |
| Warmth group | Active comparator | All participants will be offered a hat device that elicits warmth only. Receives: Device: Warmth only |
| TENS group | Active comparator | All participants will be offered a hat device that elicits TENS only. Receives: Device: Warmth + TENS; Device: TENS |
| control group | Sham comparator | All participants will be offered a hat device that without warmth or TENS output. Receives: Device: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - Baseline
The HK-MoCA will be used to assess the level of cognitive impairment. The scores of HK-MoCA ranging from 0 to 30, with a higher score indicates a higher level of cognitive function. This instrument was designed to evaluate 7 domains of cognitive functions which are key determinants of the functional performance of the participants, namely visuospatial/executive functions, naming, verbal memory registration and learning, attention, abstraction, delayed verbal memory.
Measured: Baseline (0 week)
The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - post intervention
The HK-MoCA will be used to assess the level of cognitive impairment. The scores of HK-MoCA ranging from 0 to 30, with a higher score indicates a higher level of cognitive function. This instrument was designed to evaluate 7 domains of cognitive functions which are key determinants of the functional performance of the participants, namely visuospatial/executive functions, naming, verbal memory registration and learning, attention, abstraction, delayed verbal memory.
Measured: 6 weeks
The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - short term followup
The HK-MoCA will be used to assess the level of cognitive impairment. The scores of HK-MoCA ranging from 0 to 30, with a higher score indicates a higher level of cognitive function. This instrument was designed to evaluate 7 domains of cognitive functions which are key determinants of the functional performance of the participants, namely visuospatial/executive functions, naming, verbal memory registration and learning, attention, abstraction, delayed verbal memory.
Measured: 10 weeks
The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - long term followup
The HK-MoCA will be used to assess the level of cognitive impairment. The scores of HK-MoCA ranging from 0 to 30, with a higher score indicates a higher level of cognitive function. This instrument was designed to evaluate 7 domains of cognitive functions which are key determinants of the functional performance of the participants, namely visuospatial/executive functions, naming, verbal memory registration and learning, attention, abstraction, delayed verbal memory.
Measured: 62 weeks
Secondary outcomes (8)
Chinese version of Disability Assessment for Dementia (C-DAD) - baseline
C-DAD will be used to assess the participant's ability to perform a spectrum of functional activities, such as going on an outing and housekeeping. During the assessment, a caregiver is asked to indicate if the participant was able to perform 47 daily activities within the previous weeks with the responses of 'yes', ''no' or 'not applicable'. The result will then be converted into a scale ranging from 0 to 100, with a higher score indicates a higher level of functioning.
Measured: baseline (0 week)
Chinese version of Disability Assessment for Dementia (C-DAD) - post intervention
C-DAD will be used to assess the participant's ability to perform a spectrum of functional activities, such as going on an outing and housekeeping. During the assessment, a caregiver is asked to indicate if the participant was able to perform 47 daily activities within the previous weeks with the responses of 'yes', ''no' or 'not applicable'. The result will then be converted into a scale ranging from 0 to 100, with a higher score indicates a higher level of functioning.
Measured: 6 weeks
Chinese version of Disability Assessment for Dementia (C-DAD) - short term followup
C-DAD will be used to assess the participant's ability to perform a spectrum of functional activities, such as going on an outing and housekeeping. During the assessment, a caregiver is asked to indicate if the participant was able to perform 47 daily activities within the previous weeks with the responses of 'yes', ''no' or 'not applicable'. The result will then be converted into a scale ranging from 0 to 100, with a higher score indicates a higher level of functioning.
Measured: 10 weeks
Chinese version of Disability Assessment for Dementia (C-DAD) - long term followup
C-DAD will be used to assess the participant's ability to perform a spectrum of functional activities, such as going on an outing and housekeeping. During the assessment, a caregiver is asked to indicate if the participant was able to perform 47 daily activities within the previous weeks with the responses of 'yes', ''no' or 'not applicable'. The result will then be converted into a scale ranging from 0 to 100, with a higher score indicates a higher level of functioning.
Measured: 62 weeks
Pittsburg Sleep Quality Index (PSQI) - baseline
PSQI will be used to assess the participant's sleep quality for the past months. PSQI consists of 19 individual items including sleep duration, sleep latency, sleep disturbance etc. The total score will be range from 0-21 and lower scores indicate a better sleep quality.
Measured: baseline (0 weeks)
Pittsburg Sleep Quality Index (PSQI) - post intervention
PSQI will be used to assess the participant's sleep quality for the past months. PSQI consists of 19 individual items including sleep duration, sleep latency, sleep disturbance etc. The total score will be range from 0-21 and lower scores indicate a better sleep quality.
Measured: 6 weeks
Pittsburg Sleep Quality Index (PSQI) - short term followup
PSQI will be used to assess the participant's sleep quality for the past months. PSQI consists of 19 individual items including sleep duration, sleep latency, sleep disturbance etc. The total score will be range from 0-21 and lower scores indicate a better sleep quality.
Measured: 10 weeks
Pittsburg Sleep Quality Index (PSQI) - long term followup
PSQI will be used to assess the participant's sleep quality for the past months. PSQI consists of 19 individual items including sleep duration, sleep latency, sleep disturbance etc. The total score will be range from 0-21 and lower scores indicate a better sleep quality.
Measured: 62 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start1 Mar 2019
- Primary completion2 Dec 2024 (estimated)
- Study completion2 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Prince of Wales Hospital, Shatin, Hong Kong
- Responsible party
- Principal investigator, Shamay Ng, The Hong Kong Polytechnic University
- Investigators
- SSM Ng, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03614962
- Sponsor's protocol ID
- 2018_ITF_MRP
- Status last verified
- Oct 2024
- First submitted
- 15 Jul 2018
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Warmth and Transcutaneous Electrical Nerve Stimulation (TENS) in Improving Cognitive Functions and Behavioral Symptoms in Older Adults with Dementia: a Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03614962
- Acronym / sponsor ID
- 2018_ITF_MRP
- Conditions
- Dementia
- Keywords
- Transcutaneous electrical nerve stimulation, Cognitive, Memory
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Prince of Wales Hospital, Shatin, Hong Kong
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 2 Dec 2024 (estimated)
- Study completion
- 2 Dec 2024 (estimated)
- First posted
- 3 Aug 2018 (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.
Evidence showed that both TENS and passive body heating are potential treatment strategies for improving cognitive functions in people with dementia. It is hypothesized that hat device (Warmth +TENS) over the 4 acupuncture points would induce a greater improvement in cognitive functions and behavioural symptoms when compared with other hat devices (Warmth + placebo-TENS; TENS only; Warmth alone) and Control (hat device with no warmth and no TENS).
Detailed description
Acupuncture, a primary therapeutic method in traditional Chinese medicine, has been used for patients with dementia to improve memory, orientation, calculation, and self-managing ability in patients having dementia and prevent decline of cognitive functions. Results of animal studies have demonstrated that electroacupuncture on the head region is effective in managing the symptoms associated with dementia, including vascular dementia.
A review of 8 studies on effects of TENS on non-pain related cognitive and behavioural functioning in patients with Alzheimer's disease and non-demented patients concluded that TENS could improve memory, affective behaviour and rest-activity rhythm in patients having Alzheimer's disease.
Passive body heating is another novel physical intervention strategy which potentially can relieve the symptoms of dementia. A previous study demonstrated that the attention function of 15 elderly, measured by the reaction time in the Rapid Visual Processing Test, improved after passive body heating via a thermal suit. Moreover, 30 minutes of hot-water immersion improved the sleep quality in 13 people with vascular dementia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Warmth + TENS group | Experimental | Device: Warmth + TENSAll participants will be offered a hat device that elicits warmth and TENS. |
| Warmth + placebo-TENS group | Active comparator | Device: Warmth + placebo-TENSAll participants will be offered a hat device that elicits warmth and placebo-TENS. |
| Warmth group | Active comparator | Device: Warmth onlyAll participants will be offered a hat device that elicits warmth only. |
| TENS group | Active comparator | Device: Warmth + TENS, Device: TENSAll participants will be offered a hat device that elicits TENS only. |
| control group | Sham comparator | Device: controlAll participants will be offered a hat device that without warmth or TENS output. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- are currently diagnosed having Alzheimer's disease, vascular dementia or mixed-type mild to major neurocognitive disorder based on the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM -5) by psychogeriatrician with more than 3 years of experience in dementia diagnosis;
- are categorized in the mild or moderate degree of dementia based on the Global Deterioration Scale;
- have a stable drug intake for the past 3 months;
- live with at least 1 caregiver in the community;
- are able to follow simple instructions;
Key exclusion criteria (5 listed)
- have unstable medical conditions or severe behavioural disturbances, which do not allow participation in the study as judged by the study psychogeriatrician,
- have any additional medical, cardiovascular , orthopedic or cognitive conditions, such as having uncontrolled hypertension unstable angina and comorbid schizophrenia, that would hinder proper assessment and treatment.
- use a cardiac pacemaker,
- live in old age home, elderly home or care and attention homes,
- receive long term nursing home placements of patients during the treatment phase
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 |
|---|---|---|
| Warmth + TENSA hat device will offer the electrical stimulation (pulse width of 120 milliseconds at about 100 Hz with constant current 0.02mA-0.7 mA, intensity setting at sensory threshold) over 4 acupuncture points over the scalp, including Baihui (GV20), Sishencong (EX-HN1), Fengchi (GB20) and Shenting (GV24). Selection of acupuncture points has been based on the recommendation of traditional Chinese medicine. A custom-built warmth pad surrounding the TENS electrodes could produce the controlled comfortable warmth sensation, with default setting at 37degrees to 40 degrees Celsius. | Device | TENS group, Warmth + TENS group |
| Warmth + placebo-TENSA custom-built warmth pad surrounding the TENS electrodes could produce the controlled comfortable warmth sensation, with default setting at 37degrees to 40 degrees Celsius. The TENS electrodes are presented in the cap but no output will be delivered via these electrodes. | Device | Warmth + placebo-TENS group |
| TENSA hat device will offer the electrical stimulation (pulse width of 120 milliseconds at about 100 Hz with constant current 0.02mA-0.7 mA, intensity setting at sensory threshold) over 4 acupuncture points over the scalp, including Baihui (GV20), Sishencong (EX-HN1), Fengchi (GB20) and Shenting (GV24). Selection of acupuncture points has been based on the recommendation of traditional Chinese medicine. | Device | TENS group |
| Warmth onlyA custom-built warmth pad surrounding the TENS electrodes could produce the controlled comfortable warmth sensation, with default setting at 37degrees to 40 degrees Celsius. No built-in TENS electrodes in the cap. | Device | Warmth group |
| controlNo warmth pad and TENS electrodes presented in the cap. | Device | control group |
Primary outcome
The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - Baseline
Time frame: Baseline (0 week)
The HK-MoCA will be used to assess the level of cognitive impairment. The scores of HK-MoCA ranging from 0 to 30, with a higher score indicates a higher level of cognitive function. This instrument was designed to evaluate 7 domains of cognitive functions which are key determinants of the functional performance of the participants, namely visuospatial/executive functions, naming, verbal memory registration and learning, attention, abstraction, delayed verbal memory.
The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - post intervention
Time frame: 6 weeks
The HK-MoCA will be used to assess the level of cognitive impairment. The scores of HK-MoCA ranging from 0 to 30, with a higher score indicates a higher level of cognitive function. This instrument was designed to evaluate 7 domains of cognitive functions which are key determinants of the functional performance of the participants, namely visuospatial/executive functions, naming, verbal memory registration and learning, attention, abstraction, delayed verbal memory.
The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - short term followup
Time frame: 10 weeks
The HK-MoCA will be used to assess the level of cognitive impairment. The scores of HK-MoCA ranging from 0 to 30, with a higher score indicates a higher level of cognitive function. This instrument was designed to evaluate 7 domains of cognitive functions which are key determinants of the functional performance of the participants, namely visuospatial/executive functions, naming, verbal memory registration and learning, attention, abstraction, delayed verbal memory.
The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - long term followup
Time frame: 62 weeks
The HK-MoCA will be used to assess the level of cognitive impairment. The scores of HK-MoCA ranging from 0 to 30, with a higher score indicates a higher level of cognitive function. This instrument was designed to evaluate 7 domains of cognitive functions which are key determinants of the functional performance of the participants, namely visuospatial/executive functions, naming, verbal memory registration and learning, attention, abstraction, delayed verbal memory.
8 secondary outcomes
Chinese version of Disability Assessment for Dementia (C-DAD) - baseline
Time frame: baseline (0 week)
Chinese version of Disability Assessment for Dementia (C-DAD) - post intervention
Time frame: 6 weeks
Chinese version of Disability Assessment for Dementia (C-DAD) - short term followup
Time frame: 10 weeks
Chinese version of Disability Assessment for Dementia (C-DAD) - long term followup
Time frame: 62 weeks
Pittsburg Sleep Quality Index (PSQI) - baseline
Time frame: baseline (0 weeks)
Pittsburg Sleep Quality Index (PSQI) - post intervention
Time frame: 6 weeks
Pittsburg Sleep Quality Index (PSQI) - short term followup
Time frame: 10 weeks
Pittsburg Sleep Quality Index (PSQI) - long term followup
Time frame: 62 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
Related trials for Dementia
Recruiting
Automated Language Analysis in Neurodegenerative Diseases: Application of Artificial Intelligence Models
Alzheimer's Disease (AD), Frontotemporal Dementia (FTD)
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
Active, not recruiting
Primary Care Detection of Cognitive Impairment Leveraging Health & Consumer Technologies in Underserved Communities: The MyCog Trial
Dementia, Cognitive Impairment
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Recruiting
OCT-Angiography and Adaptive Optics in Patients With Memory Impairment
Amnesia, Alzheimer Disease
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.
SSM 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 Warmth + TENS, TENS and Warmth only in people with Dementia, 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 3 Oct 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SSM Ng, PhD (+852 2766-4889, shamay.ng@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) - Baseline (time frame: Baseline (0 week)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2024.