Effect of tDCS on Upper Extremity After Strokes

Study Overview
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Brief Summary
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The investigators hypothesize that transcranial direct current stimulation (tDCS) can improve upper limb motor recovery in the sub-acute phase of stroke patients. This is a randomized, controlled, double blind, cross-over, multicentre, clinical trial.

Detailed Description
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The investigators hypothesize that transcranial direct current stimulation (tDCS) can improve upper limb motor recovery in the sub-acute phase of stroke patients. This is a randomized, controlled, double blind, cross-over, multicentre, clinical trial. Informed consent was obtained from all participants and procedures were conducted according to the Declaration of Helsinki. The protocol was approved by the Chonbuk National Uni. Hospital IRB, KOREA. Seventy-two stroke patients in the sub-acute phase will be recruited in three centers of neurorehabilitation in republic of Korea. Patients will be randomly divided to four groups; group1 is anodal stimulation on the lesioned primary motor cortex, group 2 is cathodal stimulation on the non-lesioned primary motor cortex, group 3 is dual stimulation such as anodal stimulation on the lesioned side and cathod stimulation on the non-lesioned side, and group 4 is shame stimulation group. The stimulation will be conducted 2mA for 20 minute a day, 5 days per weeks, totally 2 weeks. Fugl-Meyer upper motor score will be measured as a primary outcome.

Official Title
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Effects of Transcranial Direct Current Stimulation on Hemiplegic Upper Extremity Function After Strokes

Conditions
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Stroke

Intervention / Treatment
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* Device: DC-STIMULATOR PLUS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 20-85 Unilateral Stroke patients Inclusion must be in the sub-acute phase defined as within 48hr-4 weeks after stroke Patients who have evoked motor potentials on the first dorsal interossei muscles on hemiplegic hand The patient has subscribed the informed consent Exclusion Criteria: Insert a metal object on the head Convulsive disorders History of brain diseases other than stroke

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 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

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group 1<br>anodal stimulation on the lesioned primary motor cortex DC-STIMULATOR PLUS | Device: DC-STIMULATOR PLUS<br>* 2mA for 20minutes a day, 5 days per weeks, totally 2 weeks<br>* Other names: tDCS;|
| Experimental: treatment group 2<br>cathodal stimulation on the non-lesioned primary motor cortex DC-STIMULATOR PLUS | Device: DC-STIMULATOR PLUS<br>* 2mA for 20minutes a day, 5 days per weeks, totally 2 weeks<br>* Other names: tDCS;|
| Experimental: treatment group 3<br>dual stimulation such as anodal stimulation on the lesioned side and cathodal stimulation on the non-lesioned side DC-STIMULATOR PLUS | Device: DC-STIMULATOR PLUS<br>* 2mA for 20minutes a day, 5 days per weeks, totally 2 weeks<br>* Other names: tDCS;|
| Sham Comparator: sham group<br>sham group | Device: DC-STIMULATOR PLUS<br>* 2mA for 20minutes a day, 5 days per weeks, totally 2 weeks<br>* Other names: tDCS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Upper Motor Score change |  | before treatment, 48 hours after treatment, 4 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Manual Muscle Test (MMT) change |  | before treatment, 48 hours after treatment, 4 weeks after treatment | 
| Range of Motion (ROM) change |  | before treatment, 48 hours after treatment, 4 weeks after treatment | 
| Korean version Modified Bathel Index (KMBI) change |  | before treatment, 48 hours after treatment, 4 weeks after treatment |