Transcranial Direct Current Stimulation (tDCS)-Enhanced Stroke Recovery

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2014-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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tDCS and occupational therapy

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

Group Type EXPERIMENTAL

tDCS

Intervention Type DEVICE

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

Sham and occupational therapy

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

Group Type SHAM_COMPARATOR

Sham tDCS

Intervention Type DEVICE

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

Interventions

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tDCS

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

Intervention Type DEVICE

Sham tDCS

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

Intervention Type DEVICE

Other Intervention Names

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Transcranial Direct Current Stimulation Electric stimulation

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes