Improvement Effect of Transcranial Direct Current Stimulation (tDCS) Applied During Exercise Training in Stroke Patients With Upper Limb and Hand Motor Function

Study Overview
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Brief Summary
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The purpose of this study was to improve the effect of Transcranial Direct Current Stimulation (tDCS) applied during exercise training in stroke patients with upper limb and hand motor function.

Official Title
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Improvement Effect of Transcranial Direct Current Stimulation (tDCS) Applied During Exercise Training in Stroke Patients With Upper Limb and Hand Motor Function

Conditions
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Stroke

Intervention / Treatment
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* Device: tDCS stimulation with hand task
* Device: sham tDCS stimulation with hand task


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 19 to 80 years Less than 58 FMA Upper scores Patients whose lesions do not include stimulation regions Patients with stroke with more than 3 months of onset Exclusion Criteria: Difficult to communicate due to severe language impairment. Accompanied by an existing serious neurogenic disease Existing significant psychiatric disorders such as major schizophrenia, bipolar disorder If there are difficulties in conducting the research Any patients who are judged by the investigator to be difficult to participate in this study Patients with contraindicated MRI scans

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: Hand Tasks + M1(1mA) & aIPS(1mA) tDCS<br>20 minutes of Hand Taks + applying 30 minutes of M1(1mA) & aIPS(1mA) tDCS and fNIRS | Device: tDCS stimulation with hand task<br>* 30 minutes of intervention including tDCS stimulation with hand task and fNIRS measurements for 10 days in 4 weeks<br>|
| Active Comparator: Hand Tasks + Sham tDCS<br>20 minutes of Hand Tasks + 30 minutes of sham tDCS and fNIRS | Device: sham tDCS stimulation with hand task<br>* 30 minutes of intervention including sham tDCS stimulation with hand task and fNIRS measurements for 10 days in 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fugl-Meyer Assessment | The score is a stroke-specific, performance-based impairment index. The degree of impairment of upper and lower limbs is measured. | Session 0 (initial visit);; Session 10 (at approximatel 4 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 9-hole pegboard test | The test is a standardized, quantitative assessment used to measure finger dexterity of a patient. | Baseline(initial visit); Session 10 (at approximatel 4 weeks) | 
| Change in Grip & Tip pinch strength | The test is to measure the maximum isometric strength of hand, forearm, and finger muscles. | Baseline(initial visit); Session 10 (at approximatel 4 weeks) | 
| Change in Sequential finger tapping reaction time and accruacy | Response time and accuracy are measured during finger tapping task. | Baseline(initial visit); Session 10 (at approximatel 4 weeks) | 
| Change in 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(initial visit); Session 10 (at approximatel 4 weeks) | 
| Change in Box and 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(initial visit); Session 10 (at approximatel 4 weeks) | 
| 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. | [Time Frame: session 0 (initial visit); session 10 (at approximately 4 weeks)] | 
| Changes in Brain activation of resting-state functional MRI | Measure of Neuroplasticity | [Time Frame: session 0 (initial visit); session 10 (at approximately 4 weeks)] |