HealthyNCT04618614
The Effect of Transcranial Direct Current Stimulation of the Somatosensory Area on Upper Limb Motor Performance
A study testing HD-tDCS 1 mA to S1 and HD-tDCS 1 mA to M1 in people with Healthy, run by Ariel University at 1 site in Israel.
Trial summary
to investigate the effect of transcranial direct current stimulation of the somatosensory area on upper limb motor performance in healthy adults Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HD-tDCS 1 mA to S1 and HD-tDCS 1 mA to M1
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 10 Nov 2020to 1 Apr 2022
- 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 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged between 20 and 35
- right-hand dominant
- healthy according to self report
Who cannot join
- taking psychiatric medications
- a history of drug / alcohol abuse or dependence
- psychiatric or neurological disorder
- a history of seizures
- metal implants in their head
- musculoskeletal deficits interfering with task performance (proper reaching performance in sitting)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of High-definition Transcranial Direct Current Stimulation of the Somatosensory Area on Upper Limb Motor Performance in Healthy Adults
to investigate the effect of transcranial direct current stimulation of the somatosensory area on upper limb motor performance in healthy adults
Read the detailed description
60 healthy subjects will be randomly allocated to one of three groups: (a) 15- min of High-Definition transcranial direct current stimulation (HD-tDCS) on primary somatosensory cortex (S1) with an intensity of 1 milliampere (mA) (HD-tDCS S1); (b) 15-min of HD-tDCS on primary motor cortex (M1) with an intensity of 1 mA (HD-tDCS M1); and (c) 15-min of sham HD-tDCS (HD-tDCS sham).
The stimulation will be administered noninvasively using an M x N 9-channel high definition transcranial electrical current stimulator from Soterix Medical (New York, NY). In the HD-tDCS S1 group, the anodal stimulation will target the right postcentral gyrus. In the HD-tDCS M1 group, the anodal stimulation will target the right primary motor cortex (brodmann area 4). The location of the electrodes will be placed based on HD-Targets brain modelling software (Soterix Medical, New York, NY).
Tests (motor and sensory tasks): The non-dominant left arm will be tested. Motor task: The subjects will perform a sequential point-to-point movement task on the graphics tablet. Initially, the participants will be required to perform 3 sequences without errors to familiarize themselves with the setup, the task and the sequence. Then, they will perform the pre-test which consists of two blocks of 6 sequences, i.e. 12 sequences, with a 30 s break between blocks. Two min after starting the appropriate stimulation, they will perform 2 blocks of 6 sequences (identical to the pre-test). After finishing the tDCS stimulation, the participants will perform a post-test, which is also identical to the pre-test. Three outcome measures will be used: movement time (s), reaction time (s) and straight line deviation (cm) of the reaching movements. Sensory tasks: discriminative task (two point orientation discrimination) and proprioception task will be included. The sensory tasks will be performed with eyes blindfolded. In the discriminative task the experimenter will deliver a stimuli by a two-pronged instrument at intervals of 2,3,4,5 mm to the distal phalanx of fingers 2 and 5 of the left hand. The stimulus will be oriented either across or down (total of 16 stimuli). Subjects will be asked to Identify the orientation of the stimulation. The outcome measure will be the percentage of correct answers. In the proprioceptive task, the subjects will perform a one direction point-to-point (target) movement task on the graphics tablet. The task will include 20 movements, 10 passive movements and 10 active movements. After every passive movement with eyes blindfolded, the subject will be asked to perform a similar active movement. Initially, the participants will be asked to perform four movements to familiarize themselves with the setup (the first two movements will be passive and active movements with eyes open, and the following two movements will be passive and active movements with eyes blindfolded). The outcome measure will be the end point error (cm) which is the distance between the target and the actual arrival location.
- Conditions
- Healthy
- Being tested
- HD-tDCS 1 mA to S1, HD-tDCS 1 mA to M1, Sham control
- Keywords
- transcranial direct current stimulation, motor performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HD-tDCS 1 mA to S1Device
Anodal high definition transcranial direct current stimulation of the right primary somatosensory cortex with an intensity of 1 mA
HD-tDCS 1 mA to M1Device
Anodal high definition transcranial direct current stimulation of the right primary motor cortex with an intensity of 1 mA
Sham controlDevice
Sham stimulation of the right primary somatosensory cortex
| Study group | Role | What they receive |
|---|---|---|
| HD-tDCS S1 1 mA | Experimental | Single session of 15-min HD-tDCS to the right primary somatosensory cortex with an intensity of 1 mA. The session will last approximately one hour. Receives: Device: HD-tDCS 1 mA to S1 |
| HD-tDCS M1 1 mA | Active comparator | Single session of 15-min HD-tDCS to the right primary motor cortex with an intensity of 1 mA. The session will last approximately one hour. Receives: Device: HD-tDCS 1 mA to M1 |
| Sham control | Sham comparator | Single session of 15-min HD-tDCS to the right primary somatosensory cortex with an intensity of 1 mA. The session will last approximately one hour. Receives: Device: Sham control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in movement time (s) from baseline to intervention
Time from movement onset (first time the tangential velocity was greater than 5% of the peak tangential velocity) until the end of the movement (the last time the tangential velocity will be greater than 5% of the peak tangential velocity). Improved motor performance will be indicated by a shorter movement time.
Measured: Baseline (immediately before stimulation), two minutes after starting the stimulation
Change in movement time (s) from baseline to posttest
Time from movement onset (first time the tangential velocity was greater than 5% of the peak tangential velocity) until the end of the movement (the last time the tangential velocity will be greater than 5% of the peak tangential velocity). Improved motor performance will be indicated by a shorter movement time.
Measured: Baseline (immediately before stimulation), immediately post stimulation
Change in movement time (s) from intervention to posttest
Time from movement onset (first time the tangential velocity was greater than 5% of the peak tangential velocity) until the end of the movement (the last time the tangential velocity will be greater than 5% of the peak tangential velocity). Improved motor performance will be indicated by a shorter movement time.
Measured: Two minutes after starting the stimulation, immediately post stimulation
Change in reaction time (s) from baseline to intervention
Time between when the target appeared in green (changed color from white to green), and movement onset. Improved motor performance will be indicated by a shorter reaction time.
Measured: Baseline (immediately before stimulation), two minutes after starting the stimulation
Change in reaction time (s) from baseline to posttest
Time between when the target appeared in green (changed color from white to green), and movement onset. Improved motor performance will be indicated by a shorter reaction time.
Measured: Baseline (immediately before stimulation), immediately post stimulation
Change in reaction time (s) from intervention to posttest
Time between when the target appeared in green (changed color from white to green), and movement onset. Improved motor performance will be indicated by a shorter reaction time.
Measured: Two minutes after starting the stimulation, immediately post stimulation
Change in straight line deviation (cm) from baseline to intervention
Path deviation from a straight line (zero means no deviation). Improved motor performance will be indicated by a shorter deviation.
Measured: Baseline (immediately before stimulation), two minutes after starting the stimulation
Change in straight line deviation (cm) from baseline to posttest
Path deviation from a straight line (zero means no deviation). Improved motor performance will be indicated by a shorter deviation.
Measured: Baseline (immediately before stimulation), immediately post stimulation
Change in straight line deviation (cm) from intervention to posttest
Path deviation from a straight line (zero means no deviation). Improved motor performance will be indicated by a shorter deviation.
Measured: Two minutes after starting the stimulation, immediately post stimulation
Secondary outcomes (2)
Change in the correct answers (%) of discriminative task from baseline to posttest
Identification of the orientation of the stimulus. Improved sensation will be indicated by a higher % of correct answers.
Measured: Baseline (immediately before stimulation), immediately after the motor posttest
Change in end point error (cm) of proprioception task from baseline to posttest
The distance between the target point to the actual arrival location. Improved sensation will be indicated by a smaller distance.
Measured: Baseline (immediately before stimulation), immediately after the motor posttest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start10 Nov 2020
- Primary completion7 Jan 2021
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial (RCT)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ariel University
- Sponsor type
- University, hospital or other
- Collaborators
- Tel Aviv University
- Responsible party
- Sponsor
- Investigators
- Silvi Frenkel-Toledo, PhD, Principal investigator, Ariel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618614
- Sponsor's protocol ID
- AU-HEA-SFT-20190326-B
- Status last verified
- Jan 2021
- First submitted
- 1 Nov 2020
- Last updated
- 1 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets (Study Protocol, Statistical Analysis Plan, Informed Consent Form, Analytic Code generated during and/or analyzed during the current study) will be available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High-definition Transcranial Direct Current Stimulation of the Somatosensory Area on Upper Limb Motor Performance in Healthy Adults
- ClinicalTrials.gov ID
- NCT04618614
- Acronym / sponsor ID
- AU-HEA-SFT-20190326-B
- Conditions
- Healthy
- Keywords
- transcranial direct current stimulation, motor performance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ariel UniversityUniversity, hospital or other
- Collaborators
- Tel Aviv University
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- 7 Jan 2021 (actual)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 6 Nov 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.
to investigate the effect of transcranial direct current stimulation of the somatosensory area on upper limb motor performance in healthy adults
Detailed description
60 healthy subjects will be randomly allocated to one of three groups: (a) 15- min of High-Definition transcranial direct current stimulation (HD-tDCS) on primary somatosensory cortex (S1) with an intensity of 1 milliampere (mA) (HD-tDCS S1); (b) 15-min of HD-tDCS on primary motor cortex (M1) with an intensity of 1 mA (HD-tDCS M1); and (c) 15-min of sham HD-tDCS (HD-tDCS sham).
The stimulation will be administered noninvasively using an M x N 9-channel high definition transcranial electrical current stimulator from Soterix Medical (New York, NY). In the HD-tDCS S1 group, the anodal stimulation will target the right postcentral gyrus. In the HD-tDCS M1 group, the anodal stimulation will target the right primary motor cortex (brodmann area 4). The location of the electrodes will be placed based on HD-Targets brain modelling software (Soterix Medical, New York, NY).
Tests (motor and sensory tasks): The non-dominant left arm will be tested. Motor task: The subjects will perform a sequential point-to-point movement task on the graphics tablet. Initially, the participants will be required to perform 3 sequences without errors to familiarize themselves with the setup, the task and the sequence. Then, they will perform the pre-test which consists of two blocks of 6 sequences, i.e. 12 sequences, with a 30 s break between blocks. Two min after starting the appropriate stimulation, they will perform 2 blocks of 6 sequences (identical to the pre-test). After finishing the tDCS stimulation, the participants will perform a post-test, which is also identical to the pre-test. Three outcome measures will be used: movement time (s), reaction time (s) and straight line deviation (cm) of the reaching movements. Sensory tasks: discriminative task (two point orientation discrimination) and proprioception task will be included. The sensory tasks will be performed with eyes blindfolded. In the discriminative task the experimenter will deliver a stimuli by a two-pronged instrument at intervals of 2,3,4,5 mm to the distal phalanx of fingers 2 and 5 of the left hand. The stimulus will be oriented either across or down (total of 16 stimuli). Subjects will be asked to Identify the orientation of the stimulation. The outcome measure will be the percentage of correct answers. In the proprioceptive task, the subjects will perform a one direction point-to-point (target) movement task on the graphics tablet. The task will include 20 movements, 10 passive movements and 10 active movements. After every passive movement with eyes blindfolded, the subject will be asked to perform a similar active movement. Initially, the participants will be asked to perform four movements to familiarize themselves with the setup (the first two movements will be passive and active movements with eyes open, and the following two movements will be passive and active movements with eyes blindfolded). The outcome measure will be the end point error (cm) which is the distance between the target and the actual arrival location.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- randomized controlled trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| HD-tDCS S1 1 mA | Experimental | Device: HD-tDCS 1 mA to S1Single session of 15-min HD-tDCS to the right primary somatosensory cortex with an intensity of 1 mA. The session will last approximately one hour. |
| HD-tDCS M1 1 mA | Active comparator | Device: HD-tDCS 1 mA to M1Single session of 15-min HD-tDCS to the right primary motor cortex with an intensity of 1 mA. The session will last approximately one hour. |
| Sham control | Sham comparator | Device: Sham controlSingle session of 15-min HD-tDCS to the right primary somatosensory cortex with an intensity of 1 mA. The session will last approximately one hour. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- aged between 20 and 35
- right-hand dominant
- healthy according to self report
Key exclusion criteria (6 listed)
- taking psychiatric medications
- a history of drug / alcohol abuse or dependence
- psychiatric or neurological disorder
- a history of seizures
- metal implants in their head
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-tDCS 1 mA to S1Anodal high definition transcranial direct current stimulation of the right primary somatosensory cortex with an intensity of 1 mA | Device | HD-tDCS S1 1 mA |
| HD-tDCS 1 mA to M1Anodal high definition transcranial direct current stimulation of the right primary motor cortex with an intensity of 1 mA | Device | HD-tDCS M1 1 mA |
| Sham controlSham stimulation of the right primary somatosensory cortex | Device | Sham control |
Primary outcome
Change in movement time (s) from baseline to intervention
Time frame: Baseline (immediately before stimulation), two minutes after starting the stimulation
Time from movement onset (first time the tangential velocity was greater than 5% of the peak tangential velocity) until the end of the movement (the last time the tangential velocity will be greater than 5% of the peak tangential velocity). Improved motor performance will be indicated by a shorter movement time.
Change in movement time (s) from baseline to posttest
Time frame: Baseline (immediately before stimulation), immediately post stimulation
Time from movement onset (first time the tangential velocity was greater than 5% of the peak tangential velocity) until the end of the movement (the last time the tangential velocity will be greater than 5% of the peak tangential velocity). Improved motor performance will be indicated by a shorter movement time.
Change in movement time (s) from intervention to posttest
Time frame: Two minutes after starting the stimulation, immediately post stimulation
Time from movement onset (first time the tangential velocity was greater than 5% of the peak tangential velocity) until the end of the movement (the last time the tangential velocity will be greater than 5% of the peak tangential velocity). Improved motor performance will be indicated by a shorter movement time.
Change in reaction time (s) from baseline to intervention
Time frame: Baseline (immediately before stimulation), two minutes after starting the stimulation
Time between when the target appeared in green (changed color from white to green), and movement onset. Improved motor performance will be indicated by a shorter reaction time.
Change in reaction time (s) from baseline to posttest
Time frame: Baseline (immediately before stimulation), immediately post stimulation
Time between when the target appeared in green (changed color from white to green), and movement onset. Improved motor performance will be indicated by a shorter reaction time.
Change in reaction time (s) from intervention to posttest
Time frame: Two minutes after starting the stimulation, immediately post stimulation
Time between when the target appeared in green (changed color from white to green), and movement onset. Improved motor performance will be indicated by a shorter reaction time.
Change in straight line deviation (cm) from baseline to intervention
Time frame: Baseline (immediately before stimulation), two minutes after starting the stimulation
Path deviation from a straight line (zero means no deviation). Improved motor performance will be indicated by a shorter deviation.
Change in straight line deviation (cm) from baseline to posttest
Time frame: Baseline (immediately before stimulation), immediately post stimulation
Path deviation from a straight line (zero means no deviation). Improved motor performance will be indicated by a shorter deviation.
Change in straight line deviation (cm) from intervention to posttest
Time frame: Two minutes after starting the stimulation, immediately post stimulation
Path deviation from a straight line (zero means no deviation). Improved motor performance will be indicated by a shorter deviation.
2 secondary outcomes
Change in the correct answers (%) of discriminative task from baseline to posttest
Time frame: Baseline (immediately before stimulation), immediately after the motor posttest
Change in end point error (cm) of proprioception task from baseline to posttest
Time frame: Baseline (immediately before stimulation), immediately after the motor posttest
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Individual participant dataSharing planned: No. The datasets (Study Protocol, Statistical Analysis Plan, Informed Consent Form, Analytic Code generated during and/or analyzed during the current study) will be available from the corresponding author on reasonable request.
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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.
Silvi Frenkel-Toledo, PhD principal investigator
Ariel 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-tDCS 1 mA to S1 and HD-tDCS 1 mA to M1 in people with Healthy, run by Ariel University at 1 site in Israel.
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 3 inclusion and 6 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 1 Feb 2022. 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 Israel. 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?
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?
Change in movement time (s) from baseline to intervention (time frame: Baseline (immediately before stimulation), two minutes after starting the stimulation). The study lists 9 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 1 Feb 2022.