Transcranial Direct Current Stimulation (tDCS)-Enhanced Stroke Recovery

The University of Texas System (UT)

Status: Terminated

Conditions: Ischemic Stroke

Treatments: Device: Sham tDCS; Device: tDCS

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01007136

STU 092010-231

K23HD050267 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose is to determine whether application of a non-invasive battery powered device called transcranial direct current stimulation (tDCS) can improve recovery of hand weakness after stroke beyond what is achievable with rehabilitative treatment alone.

Enrollment: 62 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ischemic stroke causing arm weakness within 5-15 days
• no other neurological or psychiatric disease, who are able to perform study tasks

Exclusion criteria

• patients younger than 18 or older than 80 years
• patients with more than one disabling stroke
• Patients with bilateral motor impairment
• Patients with poor motivational capacity, history of severe alcohol or drug abuse
• Patients with severe language disturbances, particularly of receptive nature
• Patients with serious cognitive deficits (defined as equivalent to a MMS score of 23 or less)
• Patients with severe uncontrolled medical problems (e.g., seizures, progressive stroke syndromes, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age or others),
• Patients with unstable thyroid disease
• Patients with increased intracranial pressure
• Patients with unstable cardiac arrhythmia
• Patients with contraindication to TMS or tDCS stimulation (pacemaker, an implanted medication pump, a metal plate in the skull, or metal objects inside the eye or skull, patients who had a craniotomy, skin lesions at the site of stimulation)
• Patients who are not available for follow-up at 3 and 12 months
• Pregnancy
• Patients with contraindication to MRI will not participate in MRI

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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62 participants in 2 patient groups

tDCS and occupational therapy

Experimental group

Description:

1 mA electric current will be delivered over the lesioned motor cortex for the first 20 minutes during the one hour physical therapy.

Treatment:

Device: tDCS

Sham and occupational therapy

Sham Comparator group

Description:

Electric current will be ramped up and down over the lesioned motor cortex for the first seconds during the one hour physical therapy.

Treatment:

Device: Sham tDCS