Individualized Brain Stimulation Using Transcranial Direct Current Stimulation Simulation 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-based individualized stimulation compared to conventional stimulation and sham stimulation.

Official Title
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Individualized Brain Stimulation Using Transcranial Direct Current Stimulation Simulation in Stroke Patients

Conditions
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Stroke

Intervention / Treatment
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* Device: Transcranial Direct Current Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral stroke patients Chronic patients over 6 months after onset Patients with motor evoked potential of the first dorsal interosseous muscle 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: Individualized stimulation group<br>Patients receive five sessions of individualized stimulation obtained from brain image-based transcranial direct stimulation simulation. The simulator generates the electrode's location on the scalp. | 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>|
| Active Comparator: Conventional stimulation group<br>Patients receive five sessions of conventional stimulation with electrodes over C3 and C4 based on the 10-20 system. | 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>|
| Sham Comparator: Sham stimulation group<br>Patients receive five sessions of sham stimulation with electrodes over C3 and C4 based on the 10-20 system. | 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>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in motor evoked potential | Resting motor threshold (rMT), amplitude, and latency of motor evoked potential in the 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. The latency is defined as the time point from the onset of the stimulus to the onset of MEP. | Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions) | 
| 9-hole peg test | The test is a standardized, quantitative assessment used to measure finger dexterity of a patient. | Baseline, 1 day (immediately after one brain stimulation session) and about 14 days (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, 1 day (immediately after one brain stimulation session) and about 14 days (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, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions) | 
| 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, 1 day (immediately after one brain stimulation session) and about 14 days (immediately after five brain stimulation sessions) | 
| Sequential motor test | Response time and accuracy are measured during finger tapping task. | Baseline, 1 day (immediately after one brain stimulation session), 5 days (immediately before and after three brain stimulation sessions), and about 14 days (immediately before and after five brain stimulation sessions) |