Clinical trial NCT04577768: The Effect of Transcranial Direct Current Stimulation on Motor Performance in Healthy Adults
Official title: The Effect of Transcranial Direct Current Stimulation Intensity on Motor Performance in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: transcranial direct current stimulation
motor performance
Lead sponsor: Ariel University
Sponsor class: OTHER
Collaborators: name: Tel Aviv University
First posted: 2020-10-08
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial (RCT)
Primary purpose: OTHER

Brief summary: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in movement time (s) from baseline to intervention
timeFrame: Baseline (immediately before stimulation), two minutes after starting the stimulation
measure: Change in movement time (s) from baseline to posttest
timeFrame: Baseline (immediately before stimulation), immediately post stimulation
measure: Change in movement time (s) from baseline to retention test
timeFrame: Baseline (immediately before stimulation), 24 hours following the stimulation
measure: Change in movement time (s) from intervention to posttest
timeFrame: Two minutes after starting the stimulation, immediately post stimulation
measure: Change in movement time (s) from intervention to retention test
timeFrame: Two minutes after starting the stimulation, 24 hours following the stimulation
measure: Change in movement time (s) from posttest to retention test
timeFrame: immediately post stimulation, 24 hours following the stimulation
measure: Change in reaction time (s) from baseline to intervention
timeFrame: Baseline (immediately before stimulation), two minutes after starting the stimulation
measure: Change in reaction time (s) from baseline to posttest
timeFrame: Baseline (immediately before stimulation), immediately post stimulation
measure: Change in reaction time (s) from baseline to retention test
timeFrame: Baseline (immediately before stimulation), 24 hours following the stimulation
measure: Change in reaction time (s) from intervention to posttest
timeFrame: Two minutes after starting the stimulation, immediately post stimulation
measure: Change in reaction time (s) from intervention to retention test
timeFrame: Two minutes after starting the stimulation, 24 hours following the stimulation
measure: Change in reaction time (s) from posttest to retention test
timeFrame: immediately post stimulation, 24 hours following the stimulation
Secondary outcomes:
Other outcomes:
Locations:
city: Ariel
country: Israel
facility: Ariel University
Study officials:
affiliation: Ariel University
name: Silvi Frenkel-Toledo
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.