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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04577768
Other study ID # AU-HEA-SFT-20190326
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 11, 2019
Est. completion date February 10, 2020

Study information

Verified date September 2020
Source Ariel University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

to investigate the effect of stimulation intensity on motor performance in healthy adults.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date February 10, 2020
Est. primary completion date February 10, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
HD-tDCS 2 mA
anodal high definition transcranial direct current stimulation of the right primary motor cortex with an intensity of 2 mA
HD-tDCS 1.5 mA
anodal high definition transcranial direct current stimulation of the right primary motor cortex with an intensity of 1.5 mA
HD-tDCS sham
sham stimulation of the right primary motor cortex

Locations

Country Name City State
Israel Ariel University Ariel

Sponsors (2)

Lead Sponsor Collaborator
Ariel University Tel Aviv University

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline (immediately before stimulation), two minutes after starting the stimulation
Primary 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. Baseline (immediately before stimulation), immediately post stimulation
Primary 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. Baseline (immediately before stimulation), 24 hours following the stimulation
Primary 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. Two minutes after starting the stimulation, immediately post stimulation
Primary 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. Two minutes after starting the stimulation, 24 hours following the stimulation
Primary 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. immediately post stimulation, 24 hours following the stimulation
Primary 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. Baseline (immediately before stimulation), two minutes after starting the stimulation
Primary 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. Baseline (immediately before stimulation), immediately post stimulation
Primary 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. Baseline (immediately before stimulation), 24 hours following the stimulation
Primary 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. Two minutes after starting the stimulation, immediately post stimulation
Primary 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. Two minutes after starting the stimulation, 24 hours following the stimulation
Primary 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. immediately post stimulation, 24 hours following the stimulation
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