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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2013-02-01

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.

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Detailed Description

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Conditions

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Stroke Cerebrovascular Accident CVA Acute Stroke Acute Cerebrovascular Accident Apoplexy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Real-tDCS + PT-OT

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.

Group Type ACTIVE_COMPARATOR

Real Transcranial Direct Current Stimulation

Intervention Type DEVICE

A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue

Sham-tDCS + PT-OT

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.

Group Type SHAM_COMPARATOR

Sham Transcranial Direct Current Stimulation

Intervention Type DEVICE

A sham current runs between two electrode positions and might affect the underlying brain tissue.

Interventions

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Real Transcranial Direct Current Stimulation

A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue

Intervention Type DEVICE

Sham Transcranial Direct Current Stimulation

A sham current runs between two electrode positions and might affect the underlying brain tissue.

Intervention Type DEVICE

Other Intervention Names

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Non-invasive brain stimulation Brain stimulation Enhancing stroke recovery Non-invasive brain stimulation Brain stimulation Enhancing stroke recovery

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes