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

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.

Conditions

• Stroke
• Cerebrovascular Accident
• CVA
• Acute Stroke
• Acute Cerebrovascular Accident
• Apoplexy

Interventions

DEVICE

Real Transcranial Direct Current Stimulation

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

DEVICE

Sham Transcranial Direct Current Stimulation

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

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• Beth Israel Deaconess Medical Center

  lead OTHER

Principal Investigators

• Gottfried Schlaug, MD, PhD · Beth Israel Deaconess Medical Center / Harvard Medical School

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2006-06-30

Primary Completion

2013-02-01

Completion

2013-02-01

Countries

• United States

Study Locations