Transcranial Direct Current Stimulation (tDCS)-Enhanced Stroke Recovery

Study Overview
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Brief Summary
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The purpose is to determine whether application of a non-invasive battery powered device called transcranial direct current stimulation (tDCS) can improve recovery of hand weakness after stroke beyond what is achievable with rehabilitative treatment alone.

Official Title
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TDCS-enhanced Stroke Recovery and Cortical Reorganization

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Device: tDCS
* Device: Sham tDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ischemic stroke causing arm weakness within 5-15 days no other neurological or psychiatric disease, who are able to perform study tasks Exclusion Criteria: patients younger than 18 or older than 80 years patients with more than one disabling stroke Patients with bilateral motor impairment Patients with poor motivational capacity, history of severe alcohol or drug abuse Patients with severe language disturbances, particularly of receptive nature Patients with serious cognitive deficits (defined as equivalent to a MMS score of 23 or less) Patients with severe uncontrolled medical problems (e.g., seizures, progressive stroke syndromes, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age or others), Patients with unstable thyroid disease Patients with increased intracranial pressure Patients with unstable cardiac arrhythmia Patients with contraindication to TMS or tDCS stimulation (pacemaker, an implanted medication pump, a metal plate in the skull, or metal objects inside the eye or skull, patients who had a craniotomy, skin lesions at the site of stimulation) Patients who are not available for follow-up at 3 and 12 months Pregnancy Patients with contraindication to MRI will not participate in MRI

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tDCS and occupational therapy<br>1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy. | Device: tDCS<br>* 1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.<br>* Other names: Electric stimulation;|
| Sham Comparator: Sham and occupational therapy<br>Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy. | Device: Sham tDCS<br>* Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper Extremity Fugl-Meyer | Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance. | 2 weeks | 
| Upper Extremity Fugl-Meyer | Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance. | 3 months | 
| Upper Extremity Fugl-Meyer | Motor outcome measure for the upper extremity. Scores vary between 0-66, higher values mean better performance. | 1 year after stroke | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wolf Motor Function Test | The Wolf Motor Function Test (WMFT) is a quantitative index of upper extremity motor ability determined through the use of timed and functional tasks. The score represents the average speed the subject could perform of the timed motor tasks. The score is the average of the scores calculated from how many times would a person have completed the task, had he or she been performing it continuously for 60 seconds. The score ranges from 0 to no theoretical maximum, with higher numbers meaning faster/ better performance. (See publication Dr. Hodics et al. 2012.) | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tDCS, stroke, functional MRI, TMS