Non-invasive Brain Stimulation and Occupational Therapy To Enhance Stroke Recovery

Study Overview
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Brief Summary
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The purpose of this study is to determine whether a non-painful, non-invasive, brain-stimulation technique called transcranial direct current stimulation (tDCS) combined with traditional physical-occupational therapy (OT) will improve motor function in patients with chronic stroke. The aim is to determine the effect of applying real (anodal and/or cathodal) - in a dual configuration - vs sham (pretend) tDCS to the motor brain regions on both hemispheres - in a dual configuration - to improve motor function in chronic stroke patients. Our research in normal subjects has shown that motor skills can be enhanced if tDCS is applied to the brain's motor region during motor learning. The effects after a single session of tDCS can last for up to 30 minutes, effects of multiple sessions (one session per day) can last for weeks. Furthermore, single sessions of tDCS applied to the motor regions in stroke patients have shown that improvements in motor functions can be seen and that effects may last for at least 30 minutes. Patients enrolled in this trial will be randomized to receive either real tDCS or sham tDCS in combination with PT-OT once a day for 5 days. Assessments will be done about 3 days and 7 days after the end of the experimental treatment by investigators who are blinded to the intervention. Patients are also blinded as to whether they are receiving real or sham tDCS. We hypothesize that real tDCS applied to the motor regions in combination with PT-OT results in a subsequent improvement in motor function of the recovering hand over sham tDCS in combination with PT-OT.

Official Title
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Facilitating Motor Recovery After Stroke Using tDCS

Conditions
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CVA, Apoplexy, Stroke, Cerebrovascular Accident, Acute Stroke, Acute Cerebrovascular Accident

Intervention / Treatment
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* Device: Real Transcranial Direct Current Stimulation
* Device: Sham Transcranial Direct Current Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First time clinical ischemic stroke or cerebrovascular accident At least 5 months out from first ischemic stroke prior to study enrollment Exclusion Criteria: More than 1 stroke (older strokes) Significant pre-stroke disability A terminal medical illness or disorder with survival of less than 1 year Co-existent major neurological or psychiatric diseases (e.g., epilepsy) Use of psychoactive drugs/medications - such as antidepressants,antipsychotic, stimulating agents Active participation in other stroke recovery trials testing interventions

Ages Eligible for Study
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Minimum Age: 21 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Real-tDCS + PT-OT<br>Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with real transcranial direct current stimulation (tDCS) over the motor region for up to 30 min. | Device: Real Transcranial Direct Current Stimulation<br>* A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue<br>* Other names: Enhancing stroke recovery;|
| Sham Comparator: Sham-tDCS + PT-OT<br>Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with sham (pretend) tDCS for up to 30 min. over the motor region. | Device: Sham Transcranial Direct Current Stimulation<br>* A sham current runs between two electrode positions and might affect the underlying brain tissue.<br>* Other names: Enhancing stroke recovery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment of Upper Extremity Motor Impairment | This scale goes from 0 to 66 (max). Higher values are considered to be a better outcome. | Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wolf-Motor-Function-Test | The Wolf-Motor-Function-Test (time) is the average time in seconds taken to perform each of 15 functional tasks ranging in difficulty from putting one's forearm on a table to stacking checkers. Participants are given 120 seconds to perform a task and if they fail, they are scored 120 for that task, or similar as accurate. The average time in seconds is then log10 transformed. | Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Ischemia, Infarction, Cerebrovascular Disorder, Central Nervous System Diseases, Brain Infarction, Brain Ischemia, Rehabilitation, Recovery, Neurorehabilitation, Plasticity