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

Healthy Clinical Trial

Official title:

The Effect of High-definition Transcranial Direct Current Stimulation of the Somatosensory Area on Upper Limb Motor Performance in Healthy Adults

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04618614
• Other study ID #: AU-HEA-SFT-20190326-B
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 10, 2020
• Est. completion date: April 1, 2022

Study information

• Verified date: January 2021
• Source: Ariel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: April 1, 2022
• Est. primary completion date: January 7, 2021
• 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 / 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)

Related Conditions & MeSH terms

• Healthy

Intervention

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
• 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 control
Sham stimulation of the right primary somatosensory 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 will be greater than 5% of the peak tangential velocity). Improved motor performance will be 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 will be greater than 5% of the peak tangential velocity). Improved motor performance will be indicated by a shorter movement time.	Baseline (immediately before stimulation), immediately post 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 will be greater than 5% of the peak tangential velocity). Improved motor performance will be indicated by a shorter movement time.	Two minutes after starting the stimulation, immediately post 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 will be 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 will be indicated by a shorter reaction time.	Baseline (immediately before stimulation), immediately post 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 will be indicated by a shorter reaction time.	Two minutes after starting the stimulation, immediately post stimulation
Primary	Change in straight line deviation (cm) from baseline to intervention	Path deviation from a straight line (zero means no deviation). Improved motor performance will be indicated by a shorter deviation.	Baseline (immediately before stimulation), two minutes after starting the stimulation
Primary	Change in straight line deviation (cm) from baseline to posttest	Path deviation from a straight line (zero means no deviation). Improved motor performance will be indicated by a shorter deviation.	Baseline (immediately before stimulation), immediately post stimulation
Primary	Change in straight line deviation (cm) from intervention to posttest	Path deviation from a straight line (zero means no deviation). Improved motor performance will be indicated by a shorter deviation.	Two minutes after starting the stimulation, immediately post stimulation
Secondary	Change in the correct answers (%) of discriminative task from baseline to posttest	Identification of the orientation of the stimulus. Improved sensation will be indicated by a higher % of correct answers.	Baseline (immediately before stimulation), immediately after the motor posttest
Secondary	Change in end point error (cm) of proprioception task from baseline to posttest	The distance between the target point to the actual arrival location. Improved sensation will be indicated by a smaller distance.	Baseline (immediately before stimulation), immediately after the motor posttest