Stroke tDCS
Brain Electrical Stimulation to Enhance Recovery After Stroke
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Status:
This study has been completed
Purpose:
This study will examine whether brain stimulation using transcranial direct current stimulation (tDCS) in stroke patients undergoing rehabilitation therapy can help patients recover strength and motor function more than rehabilitation therapy alone.
Interventions:
Transcranial direct current stimulation
Transcranial direct current stimulation (tDCS) is the application of weak electrical currents (1-2 mA) to modulate the activity of neurons in the brain.
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Location(s):
Texas, Maryland, & Washington D.C.
Year Started:
2004
Year Finished:
2009
Inclusion Criteria
We will include patients aged 18-80 years old with subacute thromboembolic non-hemorrhagic subcortical or cortical strokes stratified according to the degree of impairment into mildly impaired (MRC greater than 3) and severely impaired (MRC less than 3). Assessment of the initial functional state will be taken at the admission at NRH. For healthy volunteers, subjects with a normal physical and neurological examination could participate.
Exclusion Criteria
Patients with more than one stroke in the medial cerebral artery territory; with bilateral motor impairment; with cerebellar or brainstem lesions; history of severe alcohol or drug abuse, psychiatric illnesses like severe depression, poor motivational capacity, or severe language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as equivalent to a mini-mental state exam score of 23 or less); severe uncontrolled medical problems (e.g. cardiovascular disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age, uncontrolled epilepsy or others); increased intracranial pressure as evaluated by clinical means;
unstable cardiac arrhythmia; with thyroid disorders;
more than moderate to severe microangiopathy, polyneuropathy, diabetes mellitus, or ischemic peripheral disease; pregnancy; metallic implants in the head; pacemakers; patients taking antiadrenergic medications;
For fMRI: 1) Medical or technical contraindications to MRI procedures (e.g. metal braces, pacemakers, cochlear devices, surgical clips, and other metal/magnetic implants); 2) Claustrophobia; 3) inability to comply with the protocol 4) pregnancy (a urine pregnancy test will be performed for premenopausal females prior to MRI). All other criteria stated above will also apply
For TMS: 1) Seizure disorder; 2) Metallic implant in the head; 3) Pacemaker; 4) Unable to perform the task; 5) Pregnant or breast feeding a child; 6) Patients or subjects with increased intracranial pressure as evaluated by clinical means. All other criteria stated above will also apply.
For healthy volunteers, subjects with stroke(s) or movement disorder(s); history of alcohol or drug abuse or a psychiatric illness like depression, other major medical problems that effect heart, lungs or kidneys or epilepsy or diabetes mellitus; thyroid gland problem; other diseases of the brain, like Alzheimer's disease; medical or technical contraindications to MRI procedures (e.g. metal braces, pacemakers, cochlear devices, surgical clips, and other metal/magnetic implants); claustrophobia; pregnant or breast feeding women could not participate.
Patient Involvement:
Patients who had a single ischemic stroke and have moderate to severe hand weakness but are able to activate their wrist flexors are included within 15 days of the stroke onset. Eligible patients are randomized in one of the two study arms: SRT + tDCS or in SRT + sham stimulation. Patients receive 20 minutes of tDCS or sham of the affected motor cortex simultaneously with SRT Monday-Friday for a total of ten sessions. Outcome measures are collected at discharge, 3 months and at 12 months. We perform functional MRI and TMS studies in volunteers and in a subgroup of patients at the National Institutes of Health (NIH) and at UTSW.
Primary Outcome:
The upper extremity component of Fugl-Meyer test (uFM), the Wolf Motor Function Test (WMFT), Jebsen-Tailor Test
(JTT), Motor Activity log (Uswatte, Taub et al. 2005), Medical Research Council Scale (MRC), Modified Ashworth-
Spasticity scale (ASS), Abilhand scale (AHS), Barthel Index (BI), NIH stroke scale (NIHSS).
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Source of Information:
ClinicalTrials.gov
Presented at 2009 International Stroke Conference (February 2009.
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Web Links and Publications:
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This information last updated on: 11/13/2009
Reviewed on: 11/13/2009.
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