A Study on Brain Activity During Transcranial Direct Current Stimulation in Stroke Patients

Study Overview
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Brief Summary
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The purpose of this study is to identify the characteristics of neural plasticity seen in stroke patients by measuring the changes in brain activity during stimulation using functional near-infrared spectroscopy (fNIRS) when applying transcranial direct current stimulation (tDCS) for the purpose of enhancing finger function.

Official Title
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A Study on Brain Activity During Transcranial Direct Current Stimulation for Improving Finger-Hand Function in Stroke Patients

Conditions
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Stroke

Intervention / Treatment
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* Device: Transcranial direct current simulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral stroke patients Chronic patients over 6 months after onset Subcortical stroke 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 with metal implants 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tDCS stimulation group<br>Patients receive four sessions of tDCS stimulation over C3 (patient with left-sided lesion) or C4 (patient with right-sided lesion) based on 10-20 system. | Device: Transcranial direct current simulation<br>* Four sessions of stimulation over C3 (patient with left-sided lesion) or C4 (patient with right-sided lesion) based on 10-20 system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in cortical activity using fNIRS signals during brain stimulation | Cortical activities before and after brain stimulation sessions are compared. | Baseline and about 10 days (immediately after brain stimulation sessions) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 and about 10 days (immediately after brain stimulation sessions) | 
| 9-hole pegboard test | The test is a standardized, quantitative assessment used to measure finger dexterity of a patient. | Baseline and about 10 days (immediately after brain stimulation sessions) | 
| Grip & Tip pinch strength test | The test is to measure the maximum isometric strength of hand, forearm, and finger muscles. | Baseline and about 10 days (immediately after 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 and about 10 days (immediately after 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 and about 10 days (immediately after brain stimulation sessions) | 
| Finger tapping test | Response time is measured during finger tapping task. | Baseline and about 10 days (immediately after brain stimulation sessions) |