Most Effective Stimulation Site in Transcranial Direct Current Stimulation for Gait Recovery After Stoke

Study Overview
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Brief Summary
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The aim of this study is to investigate the most effective stimulation site in transcranial direct current stimulation for gait recovery after stroke. All subjects will go through four conditions of transcranial direct current stimulation with for 30 minutes. Four conditions are 1) bihemispheric stimulation - anodal stimulation on both ipsilesional and contralesional leg area of primary motor cortex and supplementary motor area. 2) ipsilesional stimulation - anodal stimulation on ipsilesional leg area of primary motor cortex and supplementary motor area. 3) contralesional stimulation - anodal stimulation on contralesional leg area of primary motor cortex and supplementary motor area. 4) sham stimulation. Subjects will walk on treadmill for 10 minutes during transcranial direct current stimulation. Motor evoked potential and functional evaluations will be done before and after stimulation to measure the changes.

Official Title
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Most Effective Stimulation Site in Transcranial Direct Current Stimulation for Gait Recovery After Stoke

Conditions
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Stroke, Gait Disorders, Neurologic

Intervention / Treatment
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* Device: Ipsilesional stimulation
* Device: Contralesional stimulation
* Other: Walking on treadmill


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic stroke patients with 6 months after onset. Functional ambulation category ≥ 3 Exclusion Criteria: patients who needs assist in surface level walking patients with mini mental status exam score under 9 patients with implantable electronic device metal device inside skull history of epilepsy pregnancy

Ages Eligible for Study
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Minimum Age: 20 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: Bihemispheric stimulation<br>Anodal stimulation on ipsilesional leg motor primary cortex and supplementary motor area Anodal stimulation on contralesional leg motor primary cortex and supplementary motor area Subject walks on treadmill for 10 minute during stimulation. | Device: Ipsilesional stimulation<br>* anodal stimulation on Ipsilesional leg area of primary motor cortex and supplementary motor area for 30 minutes<br>Device: Contralesional stimulation<br>* anodal stimulation on contralesional leg area of primary motor cortex and supplementary motor area for 30 minutes<br>Other: Walking on treadmill<br>* walking on treadmill for 10 minutes<br>|
| Experimental: Ipsilesional stimulation<br>Anodal stimulation on ipsilesional leg motor primary cortex and supplementary motor area Sham on contralesional leg motor primary cortex and supplementary motor area Subject walks on treadmill for 10 minute during stimulation. | Device: Ipsilesional stimulation<br>* anodal stimulation on Ipsilesional leg area of primary motor cortex and supplementary motor area for 30 minutes<br>Other: Walking on treadmill<br>* walking on treadmill for 10 minutes<br>|
| Experimental: Contralesional stimulation<br>Sham stimulation on ipsilesional leg motor primary cortex and supplementary motor area Anodal stimulation on contralesional leg motor primary cortex and supplementary motor area Subject walks on treadmill for 10 minute during stimulation. | Device: Contralesional stimulation<br>* anodal stimulation on contralesional leg area of primary motor cortex and supplementary motor area for 30 minutes<br>Other: Walking on treadmill<br>* walking on treadmill for 10 minutes<br>|
| Active Comparator: Sham<br>Sham stimulation on ipsilesional leg motor primary cortex and supplementary motor area Sham stimulation on contralesional leg motor primary cortex and supplementary motor area Subject walks on treadmill for 10 minute during stimulation. | Other: Walking on treadmill<br>* walking on treadmill for 10 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in motor evoked potential | measure the motor threshold and amplitude of motor evoked potential in tibialis anterior muscle. | before and after intervention (approximately 30 minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in motricity index | measures motor function | before and after intervention (approximately 30 minutes) | 
| Changes in Fugl Meyer Assessment | Fugl Meyer Assessment is a measurement of motor function. | before and after intervention (approximately 30 minutes) | 
| Changes in 10 meter walking test | measures gait speed | before and after intervention (approximately 30 minutes) | 
| Timed up and go test | measures gait capacity and balance | before and after intervention (approximately 30 minutes) | 
| Functional ambulatory category | measure gait ability. 0 is impossible to gait and 6 is normal. | before and after intervention (approximately 30 minutes) | 
| Modified ashworth scale | measures spasticity with scale from 0 to 3. 0 is no increase in muscle tone. 3 is considerable increase in muscle tone, passive movement difficult. | before and after intervention (approximately 30 minutes) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transcranial direct current stimulation