- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04577768
The Effect of Transcranial Direct Current Stimulation on Motor Performance in Healthy Adults
The Effect of Transcranial Direct Current Stimulation Intensity on Motor Performance in Healthy Adults
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ariel, Israel
- Ariel University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- aged between 20 and 35
- right-hand dominant
- healthy according to self report
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: HD-tDCS 2 mA
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.
|
anodal high definition transcranial direct current stimulation of the right primary motor cortex with an intensity of 2 mA
|
|
Experimental: HD-tDCS 1.5 mA
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.
|
anodal high definition transcranial direct current stimulation of the right primary motor cortex with an intensity of 1.5 mA
|
|
Sham Comparator: Control
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.
|
sham stimulation of the right primary motor cortex
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline (immediately before stimulation), two minutes after starting the stimulation
|
|
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.
|
Baseline (immediately before stimulation), immediately post stimulation
|
|
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.
|
Baseline (immediately before stimulation), 24 hours following the stimulation
|
|
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.
|
Two minutes after starting the stimulation, immediately post stimulation
|
|
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.
|
Two minutes after starting the stimulation, 24 hours following the stimulation
|
|
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.
|
immediately post stimulation, 24 hours following the stimulation
|
|
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.
|
Baseline (immediately before stimulation), two minutes after starting the stimulation
|
|
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.
|
Baseline (immediately before stimulation), immediately post stimulation
|
|
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.
|
Baseline (immediately before stimulation), 24 hours following the stimulation
|
|
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.
|
Two minutes after starting the stimulation, immediately post stimulation
|
|
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.
|
Two minutes after starting the stimulation, 24 hours following the stimulation
|
|
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.
|
immediately post stimulation, 24 hours following the stimulation
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Silvi Frenkel-Toledo, Ariel University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AU-HEA-SFT-20190326
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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