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

Not Applicable

Completed

Conditions: Acute Stroke
Apoplexy
Acute Cerebrovascular Accident
Stroke
Cerebrovascular Accident
CVA

Interventions: Device: Sham Transcranial Direct Current Stimulation
Device: Real Transcranial Direct Current Stimulation

Registration Number: NCT00792428

Lead Sponsor: Beth Israel Deaconess Medical Center

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 20

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham-tDCS + PT-OT	Sham Transcranial Direct Current Stimulation	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.
Real-tDCS + PT-OT	Real Transcranial Direct Current Stimulation	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Wolf-Motor-Function-Test	Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days	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.