Cerebrovascular Accident Clinical Trial
Official title:
Effects of Transcranial DC Stimulation Coupled With Constraint Induced Movement Therapy on Motor Function in Stroke Patients
Verified date | March 2017 |
Source | Beth Israel Deaconess Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 85 |
Est. completion date | November 10, 2014 |
Est. primary completion date | November 10, 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - First time clinical ischemic or hemorrhagic cerebrovascular accident (radiologically confirmed) - Demonstrates adequate balance while wearing a hand restraint on the unaffected arm - Ability to stand from a sitting position and ability to stand with or without upper extremity support - Stroke onset at least 6 months prior to study enrollment Exclusion Criteria: - Significant pre-stroke disability - Any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing - Excessive pain in any joint of the paretic extremity - A terminal medical diagnosis consistent with survival of less than 1 year - Advanced liver, kidney, cardiac, or pulmonary disease - Coexistent major neurological or psychiatric disease (including epilepsy) - A history of significant alcohol or drug abuse in the prior 3 years - Use of neuropsychotropic drugs - such as antidepressants - Patients may not be actively enrolled in a separate intervention study targeting stroke recovery - Patients may not have already received constraint-induced movement therapy and/or tDCS treatment for stroke |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Beth Israel Deaconess Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Jebsen-Taylor Hand Function Test | Baseline, Treatment days 1,5,10, Follow Up | ||
Primary | Motor Activity Log Rating Scale | Baseline, Treatment Days 1,5,10 and Follow Up | ||
Primary | Beck Depression Inventory | Baseline, Treatment days 1,5,10 and Follow up | ||
Primary | Visual Analogue Scale for Anxiety | Baseline, Treatment days 1,5,10 and Follow Up | ||
Secondary | Fugl Meyer Assessment of Motor Recovery | Baseline Assessment | ||
Secondary | Barthel Index Score | Baseline Assessment | ||
Secondary | Modified Ashworth Scale | Baseline Assessment |
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