Non-invasive Brain Stimulation and Occupational Therapy To Enhance Stroke Recovery (TDCS+OT)

Beth Israel Lahey Health

Status: Completed

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

Treatments: Device: Real Transcranial Direct Current Stimulation; Device: Sham Transcranial Direct Current Stimulation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00792428

R01NS045049 (U.S. NIH Grant/Contract)

2005P000346

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Real-tDCS + PT-OT

Active Comparator group

Description:

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.

Treatment:

Device: Real Transcranial Direct Current Stimulation

Sham-tDCS + PT-OT

Sham Comparator group

Description:

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.

Treatment:

Device: Sham Transcranial Direct Current Stimulation