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

Completed · Not applicable · Has a placebo group

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

In brief

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.

Key facts

Study ID

NCT00792428

Run by

Beth Israel Deaconess Medical Center

People needed

20

Starts

2006-06-01

Expected to finish

2013-02-01

Last updated by the study team

2018-06-04

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• First time clinical ischemic stroke or cerebrovascular accident
• At least 5 months out from first ischemic stroke prior to study enrollment

You may not qualify if…

• 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

Where it is running

• Beth Israel Deaconess Medical Center / Harvard Medical School — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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