Brain Stimulation and Rehabilitation for Adults With Chronic, Severe Arm Motor Impairment After Stroke
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|ClinicalTrials.gov Identifier: NCT03538795|
Recruitment Status : Terminated (Ran out of funds)
First Posted : May 29, 2018
Results First Posted : December 21, 2020
Last Update Posted : December 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stroke Hemiplegia Hemiparesis||Combination Product: iTBS&eCIMT||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Case series, with a no-treatment control period before the intervention|
|Masking:||None (Open Label)|
|Official Title:||Priming the Brain for Rehabilitation: Brain Stimulation Followed by Constraint-Induced Movement Therapy in Adults With Severe Arm Paresis After Stroke|
|Actual Study Start Date :||June 11, 2018|
|Actual Primary Completion Date :||February 14, 2019|
|Actual Study Completion Date :||August 14, 2020|
Participants will first receive baseline testing followed by a no-treatment control period. Participants will then be tested again, receive the combination therapy, i.e., iTBS&eCIMT, and then receive post-treatment testing.
Combination Product: iTBS&eCIMT
All will receive eCIMT+iTBS on an outpatient basis for 4 hours/day for 15 consecutive weekdays. eCIMT will include training of the more-affected arm following shaping principles, restraint of the less-affected arm, and the Transfer Package in combination with NDT techniques to reduce tone so that shaping of movement can be carried out. The Transfer Package is a set of behavioral techniques designed to transfer therapeutic gains from the treatment setting to everyday life. iTBS will be added to prime the areas of the brain that control movement of the more-affected arm so that the responsiveness of that tissue to motor training is enhanced. Treatment sessions will alternate between 10 minute periods of iTBS (which include time for set-up and transition) and 1-hour periods of eCIMT.
- Motor Activity Log (MAL) [ Time Frame: Change from Day 0 to Day 42 ]Structured interview that assesses use of the more-affected arm in daily life. Scale range is 0 (no use of the more-affected arm) to 5 (use that is as good before stroke). Higher scores are better. Score reported is change from Day 0 to Day 42.
- Wolf Motor Function Test (WMFT) [ Time Frame: Change from Day 0 to Day 42 ]Laboratory motor performance test that assesses motor capacity of the more-affected arm. Scale range is 0 to infinite. Higher scores are better.
- Canadian Occupational Performance Measure (COPM) [ Time Frame: Change from Day 0 to Day 42 ]Structured interview that assesses use of the arms in daily life
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): NCT03538795
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|Principal Investigator:||Gitendra Uswatte, PhD||University of Alabama at Birmingham|