HealthyNCT04577768
The Effect of Transcranial Direct Current Stimulation on Motor Performance in Healthy Adults
A study testing HD-tDCS 2 mA and HD-tDCS 1.5 mA in people with Healthy, run by Ariel University at 1 site in Israel.
Trial summary
to investigate the effect of stimulation intensity on 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 2 mA and HD-tDCS 1.5 mA
- 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
- 11 Jul 2019to 10 Feb 2020
- 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 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 Transcranial Direct Current Stimulation Intensity on Motor Performance in Healthy Adults
to investigate the effect of stimulation intensity on motor performance in healthy adults.
Read the detailed description
60 healthy subjects were randomly allocated to one of three groups: (a) 20-min of High-Definition transcranial direct current stimulation (HD-tDCS) with an intensity of 2 mA (HD-tDCS 2 mA); (2) 20-min of HD-tDCS with an intensity of 1.5 mA (HD-tDCS 1.5 mA); and (3) 20-min of sham HD-tDCS (HD-tDCS sham). The stimulation was administered noninvasively using an M x N 9-channel high definition transcranial electrical current stimulator from Soterix Medical (New York, NY). The anodal stimulation targeted the right Brodmann area 4 (primary motor cortex) based on HD-Targets brain modelling software (Soterix Medical, New York, NY).
Tests: The non-dominant left arm was tested. The subjects performed a sequential point-to-point movement task on the graphics tablet. Initially, the participants were required to perform 3 sequences without errors to familiarize themselves with the setup, the task and the sequence. Then, they performed the pre-test which consisted 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 performed 2 blocks of 6 sequences (identical to the pre-test). After finishing the tDCS stimulation, the participants performed a post-test, which was also identical to the pre-test. The participants returned after 24 hours to perform a retention test, which was equivalent to the pre- and post-tests. Two outcome measures were used: movement time (s) and the reaction time (s) of the reaching movements.
- Conditions
- Healthy
- Being tested
- HD-tDCS 2 mA, HD-tDCS 1.5 mA, HD-tDCS sham
- 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 2 mADevice
anodal high definition transcranial direct current stimulation of the right primary motor cortex with an intensity of 2 mA
HD-tDCS 1.5 mADevice
anodal high definition transcranial direct current stimulation of the right primary motor cortex with an intensity of 1.5 mA
HD-tDCS shamDevice
sham stimulation of the right primary motor cortex
| Study group | Role | What they receive |
|---|---|---|
| HD-tDCS 2 mA | Experimental | Single session of 20-min HD-tDCS to the right primary motor cortex with an intensity of 2 mA. The session lasted approximately one hour. The participants returned after 24 hours to perform a retention test. Receives: Device: HD-tDCS 2 mA |
| HD-tDCS 1.5 mA | Experimental | Single session of 20-min HD-tDCS to the right primary motor cortex with an intensity of 1.5 mA. The session lasted approximately one hour. The participants returned after 24 hours to perform a retention test. Receives: Device: HD-tDCS 1.5 mA |
| Control | Sham comparator | Single session of 20-min of sham HD-tDCS. The session lasted approximately one hour. The participants returned after 24 hours to perform a retention test. Receives: Device: HD-tDCS sham |
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 was greater than 5% of the peak tangential velocity). Improved motor performance was 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 was greater than 5% of the peak tangential velocity). Improved motor performance was indicated by a shorter movement time.
Measured: Baseline (immediately before stimulation), immediately post stimulation
Change in movement time (s) from baseline to retention test
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 was greater than 5% of the peak tangential velocity). Improved motor performance was indicated by a shorter movement time.
Measured: Baseline (immediately before stimulation), 24 hours following the 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 was greater than 5% of the peak tangential velocity). Improved motor performance was indicated by a shorter movement time.
Measured: Two minutes after starting the stimulation, immediately post stimulation
Change in movement time (s) from intervention to retention test
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 was greater than 5% of the peak tangential velocity). Improved motor performance was indicated by a shorter movement time.
Measured: Two minutes after starting the stimulation, 24 hours following the stimulation
Change in movement time (s) from posttest to retention test
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 was greater than 5% of the peak tangential velocity). Improved motor performance was indicated by a shorter movement time.
Measured: immediately post stimulation, 24 hours following the 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 was 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 was indicated by a shorter reaction time.
Measured: Baseline (immediately before stimulation), immediately post stimulation
Change in reaction time (s) from baseline to retention test
Time between when the target appeared in green (changed color from white to green), and movement onset. Improved motor performance was indicated by a shorter reaction time.
Measured: Baseline (immediately before stimulation), 24 hours following the 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 was indicated by a shorter reaction time.
Measured: Two minutes after starting the stimulation, immediately post stimulation
Change in reaction time (s) from intervention to retention test
Time between when the target appeared in green (changed color from white to green), and movement onset. Improved motor performance was indicated by a shorter reaction time.
Measured: Two minutes after starting the stimulation, 24 hours following the stimulation
Change in reaction time (s) from posttest to retention test
Time between when the target appeared in green (changed color from white to green), and movement onset. Improved motor performance was indicated by a shorter reaction time.
Measured: immediately post stimulation, 24 hours following the stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start11 Jul 2019
- Primary completion10 Feb 2020
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 (actual)
Sponsor and investigators
- Lead sponsor
- Ariel University
- Sponsor type
- University, hospital or other
- Collaborators
- Tel Aviv University
- Responsible party
- Sponsor
- Investigators
- Silvi Frenkel-Toledo, Principal investigator, Ariel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04577768
- Sponsor's protocol ID
- AU-HEA-SFT-20190326
- Status last verified
- Sep 2020
- First submitted
- 23 Sep 2020
- Last updated
- 8 Oct 2020
- 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) are available from the corresponding author on reasonable request.
Publications
Lerner O, Friedman J, Frenkel-Toledo S. The effect of high-definition transcranial direct current stimulation intensity on motor performance in healthy adults: a randomized controlled trial. J Neuroeng Rehabil. 2021 Jun 26;18(1):103. doi: 10.1186/s12984-021-00899-z.
PubMed 34174914
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Transcranial Direct Current Stimulation Intensity on Motor Performance in Healthy Adults
- ClinicalTrials.gov ID
- NCT04577768
- Acronym / sponsor ID
- AU-HEA-SFT-20190326
- Conditions
- Healthy
- Keywords
- transcranial direct current stimulation, motor performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ariel UniversityUniversity, hospital or other
- Collaborators
- Tel Aviv University
- Study start
- 11 Jul 2019 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 8 Oct 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 stimulation intensity on motor performance in healthy adults.
Detailed description
60 healthy subjects were randomly allocated to one of three groups: (a) 20-min of High-Definition transcranial direct current stimulation (HD-tDCS) with an intensity of 2 mA (HD-tDCS 2 mA); (2) 20-min of HD-tDCS with an intensity of 1.5 mA (HD-tDCS 1.5 mA); and (3) 20-min of sham HD-tDCS (HD-tDCS sham). The stimulation was administered noninvasively using an M x N 9-channel high definition transcranial electrical current stimulator from Soterix Medical (New York, NY). The anodal stimulation targeted the right Brodmann area 4 (primary motor cortex) based on HD-Targets brain modelling software (Soterix Medical, New York, NY).
Tests: The non-dominant left arm was tested. The subjects performed a sequential point-to-point movement task on the graphics tablet. Initially, the participants were required to perform 3 sequences without errors to familiarize themselves with the setup, the task and the sequence. Then, they performed the pre-test which consisted 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 performed 2 blocks of 6 sequences (identical to the pre-test). After finishing the tDCS stimulation, the participants performed a post-test, which was also identical to the pre-test. The participants returned after 24 hours to perform a retention test, which was equivalent to the pre- and post-tests. Two outcome measures were used: movement time (s) and the reaction time (s) of the reaching movements.
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 2 mA | Experimental | Device: HD-tDCS 2 mASingle session of 20-min HD-tDCS to the right primary motor cortex with an intensity of 2 mA. The session lasted approximately one hour. The participants returned after 24 hours to perform a retention test. |
| HD-tDCS 1.5 mA | Experimental | Device: HD-tDCS 1.5 mASingle session of 20-min HD-tDCS to the right primary motor cortex with an intensity of 1.5 mA. The session lasted approximately one hour. The participants returned after 24 hours to perform a retention test. |
| Control | Sham comparator | Device: HD-tDCS shamSingle session of 20-min of sham HD-tDCS. The session lasted approximately one hour. The participants returned after 24 hours to perform a retention test. |
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 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 2 mAanodal high definition transcranial direct current stimulation of the right primary motor cortex with an intensity of 2 mA | Device | HD-tDCS 2 mA |
| HD-tDCS 1.5 mAanodal high definition transcranial direct current stimulation of the right primary motor cortex with an intensity of 1.5 mA | Device | HD-tDCS 1.5 mA |
| HD-tDCS shamsham stimulation of the right primary motor cortex | Device | 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 was greater than 5% of the peak tangential velocity). Improved motor performance was 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 was greater than 5% of the peak tangential velocity). Improved motor performance was indicated by a shorter movement time.
Change in movement time (s) from baseline to retention test
Time frame: Baseline (immediately before stimulation), 24 hours following 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 was greater than 5% of the peak tangential velocity). Improved motor performance was 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 was greater than 5% of the peak tangential velocity). Improved motor performance was indicated by a shorter movement time.
Change in movement time (s) from intervention to retention test
Time frame: Two minutes after starting the stimulation, 24 hours following 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 was greater than 5% of the peak tangential velocity). Improved motor performance was indicated by a shorter movement time.
Change in movement time (s) from posttest to retention test
Time frame: immediately post stimulation, 24 hours following 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 was greater than 5% of the peak tangential velocity). Improved motor performance was 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 was 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 was indicated by a shorter reaction time.
Change in reaction time (s) from baseline to retention test
Time frame: Baseline (immediately before stimulation), 24 hours following the stimulation
Time between when the target appeared in green (changed color from white to green), and movement onset. Improved motor performance was 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 was indicated by a shorter reaction time.
Change in reaction time (s) from intervention to retention test
Time frame: Two minutes after starting the stimulation, 24 hours following the stimulation
Time between when the target appeared in green (changed color from white to green), and movement onset. Improved motor performance was indicated by a shorter reaction time.
Change in reaction time (s) from posttest to retention test
Time frame: immediately post stimulation, 24 hours following the stimulation
Time between when the target appeared in green (changed color from white to green), and movement onset. Improved motor performance was indicated by a shorter reaction time.
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 8 Oct 2020.
- Derived from this study: PubMed 34174914Lerner O, Friedman J, Frenkel-Toledo S. The effect of high-definition transcranial direct current stimulation intensity on motor performance in healthy adults: a randomized controlled trial. J Neuroeng Rehabil. 2021 Jun 26;18(1):103. doi: 10.1186/s12984-021-00899-z.
- 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) are 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 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 2 mA and HD-tDCS 1.5 mA 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: finished, as of the sponsor's last update on 8 Oct 2020. 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?
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?
Change in movement time (s) from baseline to intervention (time frame: Baseline (immediately before stimulation), two minutes after starting the stimulation). The study lists 12 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 NCT04577768, which also lists 1 linked publication.
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 8 Oct 2020.