The Effect of tDCS Based on Functional Brain Imaging for Subacute Stroke Patients

Study Overview
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Brief Summary
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The purpose of this study is to investigate whether brain imaging-based hand function area tDCS stimulation is more effective than conventional stimulation or sham stimulation for improving hand motor function.

Official Title
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The Effect of tDCS Based on Functional Brain Imaging for Subacute Stroke Patients

Conditions
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Stroke

Intervention / Treatment
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* Device: Transcranial Direct Current Stimulation
* Behavioral: Hand motor task


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral stroke patients aged 19 to 80 years Patients with subacute stroke within 4 weeks of onset Patients with moderate or severe upper extremity dysfunction with an upper extremity FMA score of less than 58 in motor function evaluation Exclusion Criteria: Accompanied by an existing serious neurogenic disease Existing significant psychiatric disorders such as major schizophrenia, bipolar disorder, and dementia. If there are difficulties in conducting the research Any patients who are judged by the investigator to be difficult to participate in this study Exclusion criteria for transcranial direct current stimulation: i) Patients with implanted medical devices in the body (e.g. pacemakers) ii) When a metal object is inserted in the skull iii) If there is a wound on the skin of the attachment site iv) history of epilepsy v) Pregnant and lactating women

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fNIRS based hand motor area real stimulation<br>Real stimulation is applied to functional brain image-based hand function area (20 minutes) and then hand motor task (20 minutes). | 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: Hand motor task<br>* Various type of hand motor tasks are applied to stroke patients.<br>|
| Active Comparator: Traditional hand motor area real stimulation<br>Real stimulation is applied to the traditional hand function area (20 minutes) and then hand motor task (20 minutes). | 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: Hand motor task<br>* Various type of hand motor tasks are applied to stroke patients.<br>|
| Sham Comparator: Traditional hand motor area sham stimulation<br>Sham stimulation is applied to the traditional hand function area (20 minutes) and then hand motor task (20 minutes). | Behavioral: Hand motor task<br>* Various type of hand motor tasks are applied to stroke patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of score: 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, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of score: 9-hole pegboard test | The test is a standardized, quantitative assessment used to measure finger dexterity of a patient. | Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session | 
| Changes of score: Grip & Tip pinch strength test | The test is to measure the maximum isometric strength of hand, forearm, and finger muscles. | Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session | 
| Changes in 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, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session | 
| Changes of score: 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, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session | 
| Changes of score: Korean-Montreal Cognitive Assessment | This test is a cognitive function test tool consisting of spatiotemporal/executive function, naming, memory, attention, language function, abstraction, and orientation. | Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session | 
| Changes of score: Korean version of Modified Barthel Index | Measure of physical disability used widely to assess behaviour relating to activities of daily living for stroke patients or patients with other disabling conditions. | Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session | 
| Changes of score: Geriatric Depression Scale-Short Form | The test is a self-report measure of depression in older adults. | Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session | 
| Changes in cortical activity using fNIRS signals | Cortical activities before, during and after brain stimulation sessions are compared. | Baseline, within 48 hours after #1-10 brain stimulation sessions (5 times per week, total 2 week schedule), 1 month after ten brain stimulation session |