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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
85
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.
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.
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Jebsen-Taylor Hand Function Test
Time frame: Baseline, Treatment days 1,5,10, Follow Up
Motor Activity Log Rating Scale
Time frame: Baseline, Treatment Days 1,5,10 and Follow Up
Beck Depression Inventory
Time frame: Baseline, Treatment days 1,5,10 and Follow up
Visual Analogue Scale for Anxiety
Time frame: Baseline, Treatment days 1,5,10 and Follow Up
Fugl Meyer Assessment of Motor Recovery
Time frame: Baseline Assessment
Barthel Index Score
Time frame: Baseline Assessment
Modified Ashworth Scale
Time frame: Baseline Assessment
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