Healthy AgingNCT04349137
Cause-effect Relationships Between Brain Networks and Bimanual Coordination in Older Adults
A study testing HD-tACS in people with Healthy Aging and Healthy, run by Hasselt University at 1 site in Belgium.
Trial summary
In this study, high-definition dual-site transcranial alternating current stimulation (i.e., non-invasive brain stimulation) will be applied to boost the fronto-parietal network during a bimanual coordination task in healthy young and older adults. Read more about this study
- Who is it for?
- Ages 65 to 77 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging, Healthy
- What is being tested?
- HD-tACS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Nov 2019to 30 Sep 2021
- 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 65 to 77 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Right-handedness
- Normal cognitive functions (>25 on Montreal Cognitive Assessment Questionnaire)
- Normal vision
- Healthy
Who cannot join
- Transcranial Electric Stimulation (TES) is contra-indicated (TES screening questionnaire)
- Neurologic or psychiatric disorders
- Physical disorder(s) that might interfere with the execution of the bimanual motor task
- Alcohol and/or drug addiction
- Active smokers
- Current use of specific drugs that interfere with the central nervous system
- Skin allergies to cosmetics and lotions
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Hasselt University
Hasselt, 3500
Stefanie verstraelen, drs., +32 11 26 93 61, stefanie.verstraelen@uhasselt.be
Kim van Dun, dr., kim.vandun@uhasselt.be
About this study
In this study, high-definition dual-site transcranial alternating current stimulation (i.e., non-invasive brain stimulation) will be applied to boost the fronto-parietal network during a bimanual coordination task in healthy young and older adults. Previous studies indicated that this network is important in initial motor learning, possibly through its role in spatial working memory. Therefore, stimulation will be applied during both a pure spatial working memory test, and during a bimanual coordination task.
It is also shown that healthy older adults do not engage spatial working memory brain regions during motor learning, which is related to worse motor learning. Therefore, the investigators will investigate whether this type of stimulation can improve bimanual motor learning in healthy older adults.
Read the detailed description
A single-blind, pseudo-randomised, sham-controlled within-subject design will be used. The study consists of three experimental sessions. In each session, one out of three stimulation conditions was applied: (1) in-phase stimulation; (2) anti-phase stimulation; (3) sham stimulation. The order of the three stimulation conditions over sessions will be pseudo-randomised across participants. Within each session, stimulation is applied during the performance of two tasks: a 2-back task for assessing pure spatial working memory (sWM), and a complex bimanual tracking task (BTT) for assessing bimanual skill acquisition. To minimise learning and carry-over effects over sessions, a wash-out period of 6 weeks in between sessions is used and three different variants of the BTT task (one for each session). The order of these variants was also pseudo-randomised across participants.
For assessing sWM, participants perform an adapted version of the 2-back visuospatial match-to-sample test used in Alekseichuk et al., 2016. Participants are seated on a chair, with their right hand resting on a response box. A computer screen is placed in front of the participant. On the screen, a blue 3x3 grid is drawn on a black background. Each trial consists of three events: a stimulus, a probe, and a response period. During the stimulus, two or three white dots appear somewhere in the grid for 2150ms. After a time interval of 50ms, this is followed by the appearance of the probe, consisting of one small blue dot, lasting for 300ms. During the response period (2000ms duration), the participant is requested to either press or to not press the response button, indicating whether the location of the probe matches the location of the stimulus in the previous trial or not (i.e., 2-back condition).
For familiarisation purposes, participants are first instructed what the goal of the task is. Next, they practiced a series of ten or twenty trials without stimulation.
For the experiment (i.e., task performance during stimulation), a complete set of trials is organised in five blocks, consisting of 30 trials (i.e. 150 trials per set). The five blocks are separated by 1-minute breaks. The distribution of 2-dot or 3-dot stimulus conditions in the 150-trial set was 50%-50%, presented in random order. Forty % of the trials are matched trials (i.e. 58 trials) and 60% are non-matched trials (i.e. 87 trials).
For this study, we use three fixed sets of trials, i.e. one for each session. The order of these sets over sessions will be pseudo-randomised across participants.
For assessing initial bimanual learning, we use a complex visuomotor bimanual tracking task (BTT). Participants are seated in front of a computer screen with their arms pronated on the table. Each index finger is placed in a controller. The controllers are two rotatable dials with small grooves for finger placement. By bimanually rotating the two dials, the participant can move the position of a red cursor on the display. Left and right dial rotations induced cursor movement along the ordinate and abscissa.
The goal of the BTT is to manipulate the cursors' position in order to follow a moving target dot on a straight inclined line, presented on the display, as accurately as possible. Each BTT trial starts with the appearance of the target line. At the origin of this line, in the center of the display, a red target dot is presented for 2 seconds (i.e. preparation period). Then, an auditory GO-signal indicates the start of the movement period: the target dot begins to move at a constant speed along the line towards the peripheral end of the line, which the participant has to follow by rotating the dials simultaneously. The duration of the target dot movement from center to periphery (i.e. movement period) is 5 seconds. Between trials, a time interval of 3 seconds is implemented.
There are four different task conditions that differ in relative inter-hand frequencies (1:3 vs. 3:1) and relative directionality of the rotating dials (iso-directional [ISO] vs. non-iso-directional [NON-ISO]). More specifically, in the 1:3 condition, the right index finger has to rotate the dial three times faster than the left hand, while in the 3:1 condition, this pattern is reversed. For the ISO mode, both index fingers have to rotate the dials either to the right (ISO-R) or left (ISO-L). For the NON-ISO mode, both index fingers have to rotate the dials either inward (NON-ISO-IN) or outward (NON-ISO-OUT).
To get familiar with the task, a practice block of 16 trials without stimulation is implemented. For the experiment (i.e. task performance during stimulation), there are four blocks of 36 trials, where each task condition is repeated nine times in each block. We provide 1-minute breaks between blocks. Fifteen minutes after the end of the fourth block, a retention block of 36 trials without stimulation will be added. The order of the four task conditions within each block will be randomised.
To minimize learning effects over the three sessions, we rotated the reference frame of line orientation each time with 90 degrees.
Stimulation will be delivered by two battery-driven Direct Current (DC) stimulator PLUS devices (neuroConn and Eldith GmbH, Ilmenau, Germany). Each device is connected to a center-surround rubber ring montage, suited for focal stimulation. Each montage consists of a small circular center electrode (diameter of 20 mm) and a surrounding ring electrode (inner diameter of 40 mm and outer diameter of 60 mm). The center electrodes are positioned according to the 10-20 EEG system: in the middle between AF4 and F4, which corresponds to the junction between BA9 and BA46 (i.e. right dorsolateral prefrontal cortex (DLPFC)); and P4, which corresponds to the right posterior parietal cortex (PPC). Impedance is kept below 10kOhm using a conductive paste (Ten20, Weaver and Company, CO, USA).
In-phase stimulation will consist of 6Hz stimulation over the right DLPFC and the right PPC that is synchronized (0deg phase lag between both sites), while anti-phase stimulation will use desynchronized 6Hz stimulation (180deg phase lag between both sites). To ensure a consistent phase lag, stimulation will be applied for 1min, then stopped and restarted after 5s. The sham stimulation will make use of vibrations at 6Hz instead of electrical current to mimic the physical throbbing sensation.
- Conditions
- Healthy Aging, Healthy
- Being tested
- HD-tACS, sham HD-tACS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HD-tACSDevice
non-invasive high-definition dual-site transcranial alternating current stimulation (HD-tACS) low intensive electrical alternating currents (2 mA peak-to-peak) are externally applied to the skull at a frequency of 6Hz to entrain endogenous neural oscillatory activity.
sham HD-tACSDevice
sham non-invasive high-definition dual-site transcranial alternating current stimulation (HD-tACS)
| Study group | Role | What they receive |
|---|---|---|
| In-phase 6Hz tACS | Experimental | Transcranial alternating current stimulation (tACS) will be administered over the right PPC and the right DLPFC in a synchronized (in-phase) manner at a frequency of 6Hz Receives: Device: HD-tACS |
| Anti-phase 6Hz tACS | Active comparator | Transcranial alternating current stimulation (tACS) will be administered over the right PPC and the right DLPFC in a desynchronized (anti-phase, i.e. with a difference of 180deg) manner at a frequency of 6Hz Receives: Device: HD-tACS |
| Sham tACS | Sham comparator | A sham transcranial alternating current stimulation (tACS) will be administered over the right PPC and the right DLPFC at a frequency of 6Hz using physical vibrations instead of electrical current Receives: Device: sham HD-tACS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bimanual Coordination accuracy during the stimulation or sham
This is a motor performance measure on the bimanual tracking task that will be used in this project. The measure combines the average distance of the subject's cursor to the requested target's position, and the Euclidean distance of the subject's cursor position to the target line that has to be followed. This will be measured in the blocks that were executed during the (sham) stimulation.
Measured: day 1
Bimanual Coordination accuracy during the stimulation or sham
This is a motor performance measure on the bimanual tracking task that will be used in this project. The measure combines the average distance of the subject's cursor to the requested target's position, and the Euclidean distance of the subject's cursor position to the target line that has to be followed. This will be measured in the blocks that were executed during the (sham) stimulation.
Measured: day 25
Bimanual Coordination accuracy during the stimulation or sham
This is a motor performance measure on the bimanual tracking task that will be used in this project. The measure combines the average distance of the subject's cursor to the requested target's position, and the Euclidean distance of the subject's cursor position to the target line that has to be followed. This will be measured in the blocks that were executed during the (sham) stimulation.
Measured: day 49
Bimanual Coordination accuracy 15 minutes after stimulation or sham
This is a motor performance measure on the bimanual tracking task that will be used in this project. The measure combines the average distance of the subject's cursor to the requested target's position, and the Euclidean distance of the subject's cursor position to the target line that has to be followed. This will be measured in the retention block that was executed 15min after the (sham) stimulation.
Measured: day 1
Bimanual Coordination accuracy 15 minutes after stimulation or sham
This is a motor performance measure on the bimanual tracking task that will be used in this project. The measure combines the average distance of the subject's cursor to the requested target's position, and the Euclidean distance of the subject's cursor position to the target line that has to be followed. This will be measured in the retention block that was executed 15min after the (sham) stimulation.
Measured: day 25
Bimanual Coordination accuracy 15 minutes after stimulation or sham
This is a motor performance measure on the bimanual tracking task that will be used in this project. The measure combines the average distance of the subject's cursor to the requested target's position, and the Euclidean distance of the subject's cursor position to the target line that has to be followed. This will be measured in the retention block that was executed 15min after the (sham) stimulation.
Measured: day 49
Stability of movement during the stimulation or sham
This is a motor performance measure on the bimanual tracking task that will be used in this project. This measure is calculated by fitting a straight line through the participant's own trajectory and then measuring the average Euclidean distance of the subject's cursor position to the fitted line of the trajectory. This will be measured in the blocks that were executed during the (sham) stimulation.
Measured: day 1
Stability of movement during the stimulation or sham
This is a motor performance measure on the bimanual tracking task that will be used in this project. This measure is calculated by fitting a straight line through the participant's own trajectory and then measuring the average Euclidean distance of the subject's cursor position to the fitted line of the trajectory. This will be measured in the blocks that were executed during the (sham) stimulation.
Measured: day 25
Stability of movement during the stimulation or sham
This is a motor performance measure on the bimanual tracking task that will be used in this project. This measure is calculated by fitting a straight line through the participant's own trajectory and then measuring the average Euclidean distance of the subject's cursor position to the fitted line of the trajectory. This will be measured in the blocks that were executed during the (sham) stimulation.
Measured: day 49
Stability of movement 15 minutes after the stimulation or sham
This is a motor performance measure on the bimanual tracking task that will be used in this project. This measure is calculated by fitting a straight line through the participant's own trajectory and then measuring the average Euclidean distance of the subject's cursor position to the fitted line of the trajectory. This will be measured in the retention block that was executed 15min after the (sham) stimulation.
Measured: day 1
Stability of movement 15 minutes after the stimulation or sham
This is a motor performance measure on the bimanual tracking task that will be used in this project. This measure is calculated by fitting a straight line through the participant's own trajectory and then measuring the average Euclidean distance of the subject's cursor position to the fitted line of the trajectory. This will be measured in the retention block that was executed 15min after the (sham) stimulation.
Measured: day 25
Stability of movement 15 minutes after the stimulation or sham
This is a motor performance measure on the bimanual tracking task that will be used in this project. This measure is calculated by fitting a straight line through the participant's own trajectory and then measuring the average Euclidean distance of the subject's cursor position to the fitted line of the trajectory. This will be measured in the retention block that was executed 15min after the (sham) stimulation.
Measured: day 49
Working Memory during stimulation or sham
Working memory will be assessed using the sensitivity index. This will be measured in the blocks that were executed during the (sham) stimulation.
Measured: Day 1
Working Memory during stimulation or sham
Working memory will be assessed using the sensitivity index. This will be measured in the blocks that were executed during the (sham) stimulation.
Measured: Day 25
Working Memory during stimulation or sham
Working memory will be assessed using the sensitivity index. This will be measured in the blocks that were executed during the (sham) stimulation.
Measured: Day 49
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start1 Nov 2019
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AgingStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, prof. dr. Raf Meesen, Hasselt University
- Investigators
- Bart Van Wijmeersch, prof. dr., Study director, Hasselt UniversityRaf Meesen, prof. dr., Principal investigator, Hasselt UniversityStefanie Verstraelen, drs., Study chair, Hasselt UniversityKim van Dun, dr., Study chair, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349137
- Sponsor's protocol ID
- RWS-SV-001
- Status last verified
- Aug 2021
- First submitted
- 3 Apr 2020
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cause-effect Relationships Between Brain Networks and Bimanual Coordination in Older Adults
- ClinicalTrials.gov ID
- NCT04349137
- Acronym / sponsor ID
- RWS-SV-001
- Conditions
- Healthy Aging, Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 16 Apr 2020 (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.
In this study, high-definition dual-site transcranial alternating current stimulation (i.e., non-invasive brain stimulation) will be applied to boost the fronto-parietal network during a bimanual coordination task in healthy young and older adults. Previous studies indicated that this network is important in initial motor learning, possibly through its role in spatial working memory. Therefore, stimulation will be applied during both a pure spatial working memory test, and during a bimanual coordination task.
It is also shown that healthy older adults do not engage spatial working memory brain regions during motor learning, which is related to worse motor learning. Therefore, the investigators will investigate whether this type of stimulation can improve bimanual motor learning in healthy older adults.
Detailed description
A single-blind, pseudo-randomised, sham-controlled within-subject design will be used. The study consists of three experimental sessions. In each session, one out of three stimulation conditions was applied: (1) in-phase stimulation; (2) anti-phase stimulation; (3) sham stimulation. The order of the three stimulation conditions over sessions will be pseudo-randomised across participants. Within each session, stimulation is applied during the performance of two tasks: a 2-back task for assessing pure spatial working memory (sWM), and a complex bimanual tracking task (BTT) for assessing bimanual skill acquisition. To minimise learning and carry-over effects over sessions, a wash-out period of 6 weeks in between sessions is used and three different variants of the BTT task (one for each session). The order of these variants was also pseudo-randomised across participants.
For assessing sWM, participants perform an adapted version of the 2-back visuospatial match-to-sample test used in Alekseichuk et al., 2016. Participants are seated on a chair, with their right hand resting on a response box. A computer screen is placed in front of the participant. On the screen, a blue 3x3 grid is drawn on a black background. Each trial consists of three events: a stimulus, a probe, and a response period. During the stimulus, two or three white dots appear somewhere in the grid for 2150ms. After a time interval of 50ms, this is followed by the appearance of the probe, consisting of one small blue dot, lasting for 300ms. During the response period (2000ms duration), the participant is requested to either press or to not press the response button, indicating whether the location of the probe matches the location of the stimulus in the previous trial or not (i.e., 2-back condition).
For familiarisation purposes, participants are first instructed what the goal of the task is. Next, they practiced a series of ten or twenty trials without stimulation.
For the experiment (i.e., task performance during stimulation), a complete set of trials is organised in five blocks, consisting of 30 trials (i.e. 150 trials per set). The five blocks are separated by 1-minute breaks. The distribution of 2-dot or 3-dot stimulus conditions in the 150-trial set was 50%-50%, presented in random order. Forty % of the trials are matched trials (i.e. 58 trials) and 60% are non-matched trials (i.e. 87 trials).
For this study, we use three fixed sets of trials, i.e. one for each session. The order of these sets over sessions will be pseudo-randomised across participants.
For assessing initial bimanual learning, we use a complex visuomotor bimanual tracking task (BTT). Participants are seated in front of a computer screen with their arms pronated on the table. Each index finger is placed in a controller. The controllers are two rotatable dials with small grooves for finger placement. By bimanually rotating the two dials, the participant can move the position of a red cursor on the display. Left and right dial rotations induced cursor movement along the ordinate and abscissa.
The goal of the BTT is to manipulate the cursors' position in order to follow a moving target dot on a straight inclined line, presented on the display, as accurately as possible. Each BTT trial starts with the appearance of the target line. At the origin of this line, in the center of the display, a red target dot is presented for 2 seconds (i.e. preparation period). Then, an auditory GO-signal indicates the start of the movement period: the target dot begins to move at a constant speed along the line towards the peripheral end of the line, which the participant has to follow by rotating the dials simultaneously. The duration of the target dot movement from center to periphery (i.e. movement period) is 5 seconds. Between trials, a time interval of 3 seconds is implemented.
There are four different task conditions that differ in relative inter-hand frequencies (1:3 vs. 3:1) and relative directionality of the rotating dials (iso-directional [ISO] vs. non-iso-directional [NON-ISO]). More specifically, in the 1:3 condition, the right index finger has to rotate the dial three times faster than the left hand, while in the 3:1 condition, this pattern is reversed. For the ISO mode, both index fingers have to rotate the dials either to the right (ISO-R) or left (ISO-L). For the NON-ISO mode, both index fingers have to rotate the dials either inward (NON-ISO-IN) or outward (NON-ISO-OUT).
To get familiar with the task, a practice block of 16 trials without stimulation is implemented. For the experiment (i.e. task performance during stimulation), there are four blocks of 36 trials, where each task condition is repeated nine times in each block. We provide 1-minute breaks between blocks. Fifteen minutes after the end of the fourth block, a retention block of 36 trials without stimulation will be added. The order of the four task conditions within each block will be randomised.
To minimize learning effects over the three sessions, we rotated the reference frame of line orientation each time with 90 degrees.
Stimulation will be delivered by two battery-driven Direct Current (DC) stimulator PLUS devices (neuroConn and Eldith GmbH, Ilmenau, Germany). Each device is connected to a center-surround rubber ring montage, suited for focal stimulation. Each montage consists of a small circular center electrode (diameter of 20 mm) and a surrounding ring electrode (inner diameter of 40 mm and outer diameter of 60 mm). The center electrodes are positioned according to the 10-20 EEG system: in the middle between AF4 and F4, which corresponds to the junction between BA9 and BA46 (i.e. right dorsolateral prefrontal cortex (DLPFC)); and P4, which corresponds to the right posterior parietal cortex (PPC). Impedance is kept below 10kOhm using a conductive paste (Ten20, Weaver and Company, CO, USA).
In-phase stimulation will consist of 6Hz stimulation over the right DLPFC and the right PPC that is synchronized (0deg phase lag between both sites), while anti-phase stimulation will use desynchronized 6Hz stimulation (180deg phase lag between both sites). To ensure a consistent phase lag, stimulation will be applied for 1min, then stopped and restarted after 5s. The sham stimulation will make use of vibrations at 6Hz instead of electrical current to mimic the physical throbbing sensation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| In-phase 6Hz tACS | Experimental | Device: HD-tACSTranscranial alternating current stimulation (tACS) will be administered over the right PPC and the right DLPFC in a synchronized (in-phase) manner at a frequency of 6Hz |
| Anti-phase 6Hz tACS | Active comparator | Device: HD-tACSTranscranial alternating current stimulation (tACS) will be administered over the right PPC and the right DLPFC in a desynchronized (anti-phase, i.e. with a difference of 180deg) manner at a frequency of 6Hz |
| Sham tACS | Sham comparator | Device: sham HD-tACSA sham transcranial alternating current stimulation (tACS) will be administered over the right PPC and the right DLPFC at a frequency of 6Hz using physical vibrations instead of electrical current |
Who may qualify
- Ages
- 65 to 77 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Right-handedness
- Normal cognitive functions (>25 on Montreal Cognitive Assessment Questionnaire)
- Normal vision
- Healthy
Key exclusion criteria (8 listed)
- Transcranial Electric Stimulation (TES) is contra-indicated (TES screening questionnaire)
- Neurologic or psychiatric disorders
- Physical disorder(s) that might interfere with the execution of the bimanual motor task
- Alcohol and/or drug addiction
- Active smokers
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 |
|---|---|---|
| HD-tACSnon-invasive high-definition dual-site transcranial alternating current stimulation (HD-tACS) low intensive electrical alternating currents (2 mA peak-to-peak) are externally applied to the skull at a frequency of 6Hz to entrain endogenous neural oscillatory activity. | Device | Anti-phase 6Hz tACS, In-phase 6Hz tACS |
| sham HD-tACSsham non-invasive high-definition dual-site transcranial alternating current stimulation (HD-tACS) | Device | Sham tACS |
Primary outcome
Bimanual Coordination accuracy during the stimulation or sham
Time frame: day 1
This is a motor performance measure on the bimanual tracking task that will be used in this project. The measure combines the average distance of the subject's cursor to the requested target's position, and the Euclidean distance of the subject's cursor position to the target line that has to be followed. This will be measured in the blocks that were executed during the (sham) stimulation.
Bimanual Coordination accuracy during the stimulation or sham
Time frame: day 25
This is a motor performance measure on the bimanual tracking task that will be used in this project. The measure combines the average distance of the subject's cursor to the requested target's position, and the Euclidean distance of the subject's cursor position to the target line that has to be followed. This will be measured in the blocks that were executed during the (sham) stimulation.
Bimanual Coordination accuracy during the stimulation or sham
Time frame: day 49
This is a motor performance measure on the bimanual tracking task that will be used in this project. The measure combines the average distance of the subject's cursor to the requested target's position, and the Euclidean distance of the subject's cursor position to the target line that has to be followed. This will be measured in the blocks that were executed during the (sham) stimulation.
Bimanual Coordination accuracy 15 minutes after stimulation or sham
Time frame: day 1
This is a motor performance measure on the bimanual tracking task that will be used in this project. The measure combines the average distance of the subject's cursor to the requested target's position, and the Euclidean distance of the subject's cursor position to the target line that has to be followed. This will be measured in the retention block that was executed 15min after the (sham) stimulation.
Bimanual Coordination accuracy 15 minutes after stimulation or sham
Time frame: day 25
This is a motor performance measure on the bimanual tracking task that will be used in this project. The measure combines the average distance of the subject's cursor to the requested target's position, and the Euclidean distance of the subject's cursor position to the target line that has to be followed. This will be measured in the retention block that was executed 15min after the (sham) stimulation.
Bimanual Coordination accuracy 15 minutes after stimulation or sham
Time frame: day 49
This is a motor performance measure on the bimanual tracking task that will be used in this project. The measure combines the average distance of the subject's cursor to the requested target's position, and the Euclidean distance of the subject's cursor position to the target line that has to be followed. This will be measured in the retention block that was executed 15min after the (sham) stimulation.
Stability of movement during the stimulation or sham
Time frame: day 1
This is a motor performance measure on the bimanual tracking task that will be used in this project. This measure is calculated by fitting a straight line through the participant's own trajectory and then measuring the average Euclidean distance of the subject's cursor position to the fitted line of the trajectory. This will be measured in the blocks that were executed during the (sham) stimulation.
Stability of movement during the stimulation or sham
Time frame: day 25
This is a motor performance measure on the bimanual tracking task that will be used in this project. This measure is calculated by fitting a straight line through the participant's own trajectory and then measuring the average Euclidean distance of the subject's cursor position to the fitted line of the trajectory. This will be measured in the blocks that were executed during the (sham) stimulation.
Stability of movement during the stimulation or sham
Time frame: day 49
This is a motor performance measure on the bimanual tracking task that will be used in this project. This measure is calculated by fitting a straight line through the participant's own trajectory and then measuring the average Euclidean distance of the subject's cursor position to the fitted line of the trajectory. This will be measured in the blocks that were executed during the (sham) stimulation.
Stability of movement 15 minutes after the stimulation or sham
Time frame: day 1
This is a motor performance measure on the bimanual tracking task that will be used in this project. This measure is calculated by fitting a straight line through the participant's own trajectory and then measuring the average Euclidean distance of the subject's cursor position to the fitted line of the trajectory. This will be measured in the retention block that was executed 15min after the (sham) stimulation.
Stability of movement 15 minutes after the stimulation or sham
Time frame: day 25
This is a motor performance measure on the bimanual tracking task that will be used in this project. This measure is calculated by fitting a straight line through the participant's own trajectory and then measuring the average Euclidean distance of the subject's cursor position to the fitted line of the trajectory. This will be measured in the retention block that was executed 15min after the (sham) stimulation.
Stability of movement 15 minutes after the stimulation or sham
Time frame: day 49
This is a motor performance measure on the bimanual tracking task that will be used in this project. This measure is calculated by fitting a straight line through the participant's own trajectory and then measuring the average Euclidean distance of the subject's cursor position to the fitted line of the trajectory. This will be measured in the retention block that was executed 15min after the (sham) stimulation.
Working Memory during stimulation or sham
Time frame: Day 1
Working memory will be assessed using the sensitivity index. This will be measured in the blocks that were executed during the (sham) stimulation.
Working Memory during stimulation or sham
Time frame: Day 25
Working memory will be assessed using the sensitivity index. This will be measured in the blocks that were executed during the (sham) stimulation.
Working Memory during stimulation or sham
Time frame: Day 49
Working memory will be assessed using the sensitivity index. This will be measured in the blocks that were executed during the (sham) stimulation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Individual participant dataSharing planned: No. IPD will not be shared with other researchers
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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.
Bart Van Wijmeersch, prof. dr. study director
Hasselt University
Raf Meesen, prof. dr. principal investigator
Hasselt University
Stefanie Verstraelen, drs. study chair
Hasselt 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 HD-tACS in people with Healthy Aging and Healthy, run by Hasselt University at 1 site in Belgium.
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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 30 Aug 2021. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raf Meesen, prof. dr. (+32 11 26 21 24, raf.meesen@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bimanual Coordination accuracy during the stimulation or sham (time frame: day 1). The study lists 15 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 30 Aug 2021.