The Effect of tDCS on Motor Learning and Neural Network in Stroke Patients

Study Overview
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Brief Summary
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This study is to investigate the effect of transcranial direct current stimulation (tDCS) simulation on motor learning to stroke patients compared to sham stimulation

Official Title
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Investigation of Compensational Mechanism and Effect of Transcranial Direct Stimulation on Motor Learning Through Neural Network Analysis in Stroke Patients

Conditions
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Stroke

Intervention / Treatment
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* Device: Transcranial Direct Current Stimulation
* Behavioral: Motor learning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral stroke including basal ganglia lesion patients Chronic patients over 6 months after onset Patients with the movement of fingers Exclusion Criteria: History of psychiatric disease Significant other neurological diseases except for stroke Difficult to perform this experiment Patients who are deemed difficult to participate in this research by the investigator Patients with metal implants and medical devices History of epilepsy Pregnancy Skin defect at the site of electrode attachment

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real stimulation before motor learning training<br>Patients receive five sessions of tDCS stimulation over C3 (patient with left-sided lesion) or C4 (patient with right-sided lesion) based on 10-20 system immediately before sequential finger tapping task. | Device: Transcranial Direct Current Stimulation<br>* Transcranial direct current stimulation is a form of noninvasive neuromodulation that uses constant and low direct current delivered via electrodes on the scalp.<br>Behavioral: Motor learning<br>* Sequential finger tapping task training is applied to stroke patients.<br>|
| Active Comparator: Sham stimulation before motor learning training<br>Patients receive five sessions of sham stimulation over C3 (patient with left-sided lesion) or C4 (patient with right-sided lesion) based on 10-20 system immediately before sequential finger tapping task. | Behavioral: Motor learning<br>* Sequential finger tapping task training is applied to stroke patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment | The score is a stroke-specific, performance-based impairment index. The degree of impairment of upper and lower limbs is measured. | Baseline, immediately after five brain stimulation sessions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in cortical activity using fNIRS signals during brain stimulation | Cortical activities before, during and after brain stimulation sessions are compared. | Baseline, during, immediately after five brain stimulation sessions | 
| Changes in motor evoked potential | Resting motor threshold (rMT) and amplitude of motor evoked potential in first dorsal interosseous muscle are measured. These outcomes are measured by transcranial magnetic stimulation over the motor hotspot. The rMT is defined as the minimum stimulus intensity that produced a minimal motor evoked response at rest. The amplitude means peak to peak of the muscle response. | Baseline, immediately after five brain stimulation sessions | 
| 9-hole pegboard test | The test is a standardized, quantitative assessment used to measure finger dexterity of a patient. | Baseline, immediately after five brain stimulation sessions | 
| Grip & Tip pinch strength test | The test is to measure the maximum isometric strength of hand, forearm, and finger muscles. | Baseline, immediately after five brain stimulation sessions | 
| Box & Block test | The test is used to measure the gross manual dexterity of a patient, or of a person using an upper limb prosthetic device. | Baseline, immediately after five brain stimulation sessions | 
| Sequential Finger tapping test | Response time is measured during sequential finger tapping task. | Baseline, immediately after five brain stimulation sessions | 
| Jebsen-Taylor hand function test | This test is a standardized and objective measure of fine and gross motor hand function using simulated activities of daily living (ADL). | Baseline, immediately after five brain stimulation sessions |