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Sponsored by: |
Beth Israel Deaconess Medical Center |
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Information provided by: | Beth Israel Deaconess Medical Center |
ClinicalTrials.gov Identifier: | NCT00542256 |
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.
Condition | Intervention | Phase |
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Cerebrovascular Accident |
Device: Active transcranial Direct Current Stimulation / Constraint Induced Movement Therapy Device: Sham transcranial Direct Current Stimulation / Constraint Induced Movement Therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment |
Official Title: | Effects of Transcranial DC Stimulation Coupled With Constraint Induced Movement Therapy on Motor Function in Stroke Patients |
Estimated Enrollment: | 50 |
Study Start Date: | September 2007 |
Arms | Assigned Interventions |
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1: Active Comparator
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.
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Device: Active 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.
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2: Sham Comparator
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.
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Device: Sham 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.
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Julie A Williams, M.Sc. | 617-667-5261 | jawillia@bidmc.harvard.edu |
United States, Massachusetts | |
Beth Israel Deaconess Medical Center | Recruiting |
Boston, Massachusetts, United States, 02215 | |
Principal Investigator: Felipe Fregni, MD, PhD | |
Sub-Investigator: Alvaro Pascual-Leone, MD, PhD | |
Sub-Investigator: Asli Demirtas, MD | |
Sub-Investigator: Mariana Lopes, MD | |
Sub-Investigator: Julie A Williams, M.Sc. |
Principal Investigator: | Felipe Fregni, MD, PhD | Beth Israel Deaconess Medical Center |
Study ID Numbers: | 0735535T |
Study First Received: | October 10, 2007 |
Last Updated: | May 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00542256 |
Health Authority: | United States: Institutional Review Board |
Apoplexy Cerebral Stroke Cerebrovascular Accident, Acute Cerebrovascular Apoplexy Cerebrovascular Stroke |
CVA (Cerebrovascular Accident) Stroke Stroke, Acute Vascular Accident, Brain |
Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases Brain Ischemia |
Ischemia Brain Infarction Brain Diseases Infarction Cerebrovascular Disorders |
Nervous System Diseases Cardiovascular Diseases |