Anodal and Cathodal Transcranial Direct Current Stimulation in Stroke Recovery

Study Overview
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Brief Summary
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The purpose of this study will to compare the long-term effect of anodal versus cathodal transcranial direct current stimulation (tDCS) on motor recovery in subacute stroke patients. Forty patients with subacute ischemic stroke will randomly assigned to one of three groups: Anodal, Cathodal and Sham. Each group will receive tDCS at an intensity of 2mA for 25 minutes daily for 6 consecutive days over the affected (Anodal, Sham) or unaffected (Cathodal) motor cortex. Patients will be assessed with National Institutes of Health Stroke Scale (NIHSS), the Barthel index (BI) and the Medical Research Council (MRC) muscle strength scale at baseline, after end of the 6th tDCS session, and then 1, 2 and 3 months later. Motor cortical excitability will be measured at baseline and after the 6th session in both hemispheres.

Official Title
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Effect of Anodal Versus Cathodal Transcranial Direct Current Stimulation on Stroke Recovery: a Pilot Randomized Controlled Trial

Conditions
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Stroke

Intervention / Treatment
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* Procedure: transcranial direct current stimulation (Anodal)
* Procedure: transcranial direct current stimulation (Cathodal)
* Procedure: transcranial direct current stimulation (Sham)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: acute hemiparesis with single thromboembolic non-hemorrhagic infarction documented by magnetic resonance imaging (MRI) Accept to participate in the study Exclusion Criteria: extensive infarction (taking all territories of middle cerebral artery) severe flaccid hemiplegia head injury Any other neurological disease other than stroke previous administration of tranquilizer patients who are unable to give informed consent because of severe aphasia, or cognitive deficit. Patients with no motor evoked response recorded from First Dorsal Interosseus (FDI) muscle of the affected hand

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anodal tDCS<br> | Procedure: transcranial direct current stimulation (Anodal)<br>* The anodal group will receive tDCS for 25 minutes at 2mA daily for 6 consecutive days on the affected hemisphere.<br>|
| Active Comparator: Cathodal tDCS<br> | Procedure: transcranial direct current stimulation (Cathodal)<br>* The Cathodal group will receive tDCS for 25 minutes at 2mA daily for 6 consecutive days on the unaffected hemisphere.<br>|
| Sham Comparator: Sham<br> | Procedure: transcranial direct current stimulation (Sham)<br>* The sham group will receive sham tDCS for 25 minutes daily for 6 consecutive days on the affected hemisphere.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor power improvement | improvement in the motor power of paretic patient as measured in one proximal and one distal muscle group testing in upper (shoulder abduction + hand grip) and lower limbs ( hip flexion + toes dorsiflexion). | 3 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor cortical excitability | The difference in the motor cortical excitability (RMT, AMT) before and after tDCS | 1 Month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemic stroke, direct current stimulation, motor threshold, National institutes of Health Stroke Scale, Barthel index scale, Measurement of motor power improvement