Trials / Completed
CompletedNCT00542256
tDCS and Physical Therapy in Stroke
Effects of Transcranial DC Stimulation Coupled With Constraint Induced Movement Therapy on Motor Function in Stroke Patients
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 85 (actual)
- Sponsor
- Beth Israel Deaconess Medical Center · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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. |
Timeline
- Start date
- 2007-09-01
- Primary completion
- 2014-11-10
- Completion
- 2014-11-10
- First posted
- 2007-10-11
- Last updated
- 2017-03-21
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00542256. Inclusion in this directory is not an endorsement.