An interventional study of Active transcranial Direct Current Stimulation / Constraint Induced Movement Therapy and Sham transcranial Direct Current Stimulation / Constraint Induced Movement Therapy in Cerebrovascular Accident, sponsored by Beth Israel Deaconess Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-03-21.
Sponsored by Beth Israel Deaconess Medical Center · Not applicable, Interventional, and Treatment
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's enrollment of 85 is above the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.
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Exclusion Criteria:
Each subject will receive 14 days (2 week period: 10 weekdays and 2 weekends) of constraint induced movement therapy. In addition, on the 10 weekdays during the treatment period, the subjects will come into the laboratory and receive up to 6 hours per day of training of the affected arm in a variety of tasks. At the beginning of each of the 10 weekday training sessions, participants will receive 40 minutes of active tDCS over the primary motor cortex.
Device: Active transcranial Direct Current Stimulation / Constraint Induced Movement Therapy
Each subject will receive 14 days (2 week period: 10 weekdays and 2 weekends) of constraint induced movement therapy. In addition, on the 10 weekdays during the treatment period, the subjects will come into the laboratory and receive up to 6 hours per day of training of the affected arm in a variety of tasks. At the beginning of each training day tDCS will be applied for 40 minutes with the current active for only 30 seconds over the primary motor cortex.
Device: Sham 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.
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.
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
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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Beth Israel Deaconess Medical Center