Non-invasive Brain Stimulation and Occupational Therapy To Enhance Stroke Recovery (TDCS+OT)
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|ClinicalTrials.gov Identifier: NCT00792428|
Recruitment Status : Completed
First Posted : November 18, 2008
Results First Posted : July 11, 2017
Last Update Posted : June 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Stroke Cerebrovascular Accident CVA Acute Stroke Acute Cerebrovascular Accident Apoplexy||Device: Real Transcranial Direct Current Stimulation Device: Sham Transcranial Direct Current Stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Facilitating Motor Recovery After Stroke Using tDCS|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||February 1, 2013|
|Actual Study Completion Date :||February 1, 2013|
Active Comparator: Real-tDCS + PT-OT
Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with real transcranial direct current stimulation (tDCS) over the motor region for up to 30 min.
Device: Real Transcranial Direct Current Stimulation
A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue
Sham Comparator: Sham-tDCS + PT-OT
Each subject will receive up to 5 days of traditional physical-occupational therapy for at least 1 hour per day in the stroke recovery laboratory in combination with sham (pretend) tDCS for up to 30 min. over the motor region.
Device: Sham Transcranial Direct Current Stimulation
A sham current runs between two electrode positions and might affect the underlying brain tissue.
- Fugl-Meyer Assessment of Upper Extremity Motor Impairment [ Time Frame: Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days ]This scale goes from 0 to 66 (max). Higher values are considered to be a better outcome.
- Wolf-Motor-Function-Test [ Time Frame: Baseline Assessment; 3 days after 5 treatment days; 7 days after 5 treatment days ]The Wolf-Motor-Function-Test (time) is the average time in seconds taken to perform each of 15 functional tasks ranging in difficulty from putting one's forearm on a table to stacking checkers. Participants are given 120 seconds to perform a task and if they fail, they are scored 120 for that task," or similar as accurate. The average time in seconds is then log10 transformed.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00792428
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center / Harvard Medical School|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Gottfried Schlaug, MD, PhD||Beth Israel Deaconess Medical Center / Harvard Medical School|