Cerebrovascular Accident
Conditions
Keywords
Apoplexy, Cerebral Stroke, Cerebrovascular Accident, Acute, Cerebrovascular Apoplexy, Cerebrovascular Stroke, CVA (Cerebrovascular Accident), Stroke, Stroke, Acute, Vascular Accident, Brain
Brief summary
The purpose of this study is to determine whether a painless and noninvasive procedure called transcranial direct current stimulation (tDCS) combined with a method of physical therapy called constraint-induced movement therapy improves motor function in patients with chronic stroke. Research in healthy subjects has shown that when tDCS is combined with motor learning tasks, there is an increase in learning as compared to motor learning tasks only. The tDCS procedure sessions will be compared to sham (fake) procedure sessions, which is also called placebo stimulation. This study is double blind, which means neither the subjects nor researchers analyzing motor function will know if participants are receiving real tDCS stimulation or placebo. Only the person performing the procedure will know which one participants are receiving. Only by comparing the tDCS procedure to a sham (placebo) procedure can we understand if the tDCS actually improves motor function. We hypothesize that tDCS will enhance the effects of constraint-induced movement therapy on motor recovery in chronic stroke patients.
Interventions
DEVICEActive transcranial Direct Current Stimulation / Constraint Induced Movement Therapy
14 days of constraint induced movement therapy with 10 weekdays of up to 6 hours of training of the affected arm combined with application of tDCS over the primary motor cortex for 40 minutes.
DEVICESham transcranial Direct Current Stimulation / Constraint Induced Movement Therapy
14 days of constraint induced movement therapy with 10 days of up to 6 hours of training in the affected arm and sham tDCS applied over the primary motor cortex for 40 minutes with active current applied for 30 seconds.
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* First time clinical ischemic or hemorrhagic cerebrovascular accident (radiologically confirmed) * Demonstrates adequate balance while wearing a hand restraint on the unaffected arm * Ability to stand from a sitting position and ability to stand with or without upper extremity support * Stroke onset at least 6 months prior to study enrollment
Exclusion criteria
* Significant pre-stroke disability * Any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing * Excessive pain in any joint of the paretic extremity * A terminal medical diagnosis consistent with survival of less than 1 year * Advanced liver, kidney, cardiac, or pulmonary disease * Coexistent major neurological or psychiatric disease (including epilepsy) * A history of significant alcohol or drug abuse in the prior 3 years * Use of neuropsychotropic drugs - such as antidepressants * Patients may not be actively enrolled in a separate intervention study targeting stroke recovery * Patients may not have already received constraint-induced movement therapy and/or tDCS treatment for stroke
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Jebsen-Taylor Hand Function Test | Baseline, Treatment days 1,5,10, Follow Up |
| Motor Activity Log Rating Scale | Baseline, Treatment Days 1,5,10 and Follow Up |
| Beck Depression Inventory | Baseline, Treatment days 1,5,10 and Follow up |
| Visual Analogue Scale for Anxiety | Baseline, Treatment days 1,5,10 and Follow Up |
Secondary
| Measure | Time frame |
|---|---|
| Barthel Index Score | Baseline Assessment |
| Modified Ashworth Scale | Baseline Assessment |
| Fugl Meyer Assessment of Motor Recovery | Baseline Assessment |
Countries
United States
Outcome results
None listed