The Effect of Transcranial Direct Current Stimulation of the Somatosensory Area on Upper Limb Motor Performance

Sponsor
Ariel University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04618614
Collaborator
Tel Aviv University (Other)
60
1
3
16.7
3.6

Study Details

Study Description

Brief Summary

to investigate the effect of transcranial direct current stimulation of the somatosensory area on upper limb motor performance in healthy adults

Condition or Disease Intervention/Treatment Phase
  • Device: HD-tDCS 1 mA to S1
  • Device: HD-tDCS 1 mA to M1
  • Device: Sham control
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized controlled trial (RCT)randomized controlled trial (RCT)
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
The Effect of High-definition Transcranial Direct Current Stimulation of the Somatosensory Area on Upper Limb Motor Performance in Healthy Adults
Actual Study Start Date :
Nov 10, 2020
Actual Primary Completion Date :
Jan 7, 2021
Anticipated Study Completion Date :
Apr 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: HD-tDCS S1 1 mA

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.

Device: HD-tDCS 1 mA to S1
Anodal high definition transcranial direct current stimulation of the right primary somatosensory cortex with an intensity of 1 mA

Active Comparator: HD-tDCS M1 1 mA

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.

Device: HD-tDCS 1 mA to M1
Anodal high definition transcranial direct current stimulation of the right primary motor cortex with an intensity of 1 mA

Sham Comparator: Sham control

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.

Device: Sham control
Sham stimulation of the right primary somatosensory cortex

Outcome Measures

Primary Outcome Measures

  1. Change in movement time (s) from baseline to intervention [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.

  2. Change in movement time (s) from baseline to posttest [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.

  3. Change in movement time (s) from intervention to posttest [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.

  4. Change in reaction time (s) from baseline to intervention [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.

  5. Change in reaction time (s) from baseline to posttest [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.

  6. Change in reaction time (s) from intervention to posttest [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.

  7. Change in straight line deviation (cm) from baseline to intervention [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.

  8. Change in straight line deviation (cm) from baseline to posttest [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.

  9. Change in straight line deviation (cm) from intervention to posttest [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.

Secondary Outcome Measures

  1. Change in the correct answers (%) of discriminative task from baseline to posttest [Baseline (immediately before stimulation), immediately after the motor posttest]

    Identification of the orientation of the stimulus. Improved sensation will be indicated by a higher % of correct answers.

  2. Change in end point error (cm) of proprioception task from baseline to posttest [Baseline (immediately before stimulation), immediately after the motor posttest]

    The distance between the target point to the actual arrival location. Improved sensation will be indicated by a smaller distance.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • aged between 20 and 35

  • right-hand dominant

  • healthy according to self report

Exclusion Criteria:
  • 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ariel University Ariel Israel

Sponsors and Collaborators

  • Ariel University
  • Tel Aviv University

Investigators

  • Principal Investigator: Silvi Frenkel-Toledo, PhD, Ariel University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ariel University
ClinicalTrials.gov Identifier:
NCT04618614
Other Study ID Numbers:
  • AU-HEA-SFT-20190326-B
First Posted:
Nov 6, 2020
Last Update Posted:
Feb 1, 2022
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ariel University

Study Results

No Results Posted as of Feb 1, 2022