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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active transcranial Direct Current Stimulation / Constraint Induced Movement Therapy | Device | 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. |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl Meyer Assessment of Motor Recovery | Baseline Assessment | |
| Barthel Index Score | Baseline Assessment | |
| Modified Ashworth Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Felipe Fregni, MD, PhD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33175411 | Derived | Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000098483 | Constraint Induced Movement Therapy |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Sham transcranial Direct Current Stimulation / Constraint Induced Movement Therapy | Device | 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. |
|
| Baseline Assessment |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |