Status:
COMPLETED
Predictors of Response in Chronic Stroke
Lead Sponsor:
VA Pittsburgh Healthcare System
Collaborating Sponsors:
University of Pittsburgh
Conditions:
Stroke
Brain Diseases
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
This study will validate a predictive model that uses demographics, functional status, neurophysiology, neuroanatomy, and other potential biomarkers to predict the likelihood of a clinically significa...
Detailed Description
After informed consent, a baseline neurological exam, medical records review, MRI of the brain, TMS, questionnaires, cognitive testing, robot evaluations, and arm function testing will occur. Baseline...
Eligibility Criteria
Inclusion
- Clinically defined, unilateral, hemiparetic stroke with radiologic exclusion of other possible diagnosis
- Stroke onset at least 6 months before enrollment
- Present with Mild/Moderate to Severe arm dysfunction (based on Fugl-Meyer scores of 10 to 45)
- Be medically stable to participate in the study
- Be English speaking
Exclusion
- Unable to give informed consent
- Have a serious complicating medical illness that would preclude participation.
- Contractures or orthopedic problems limiting range of joint motion in the potential study arm
- Visual loss such that the subject would not be able to see the test patterns on the robot computer monitor
- Botulinum toxin to study arm within four months of study enrollment or if received during the study period
- Unable to comply with requirements of the study
- Participants with a history of a seizure will not be precluded from the study, but will not be enrolled in the TMS portions
- Participants with electromagnetic exclusions (metal implants in the cranium, implanted electronic devices etc.) will not be precluded from the study but will be excluded from the MRI and TMS portions
- Have a serious complicating medical illness that would preclude participation
Key Trial Info
Start Date :
October 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2020
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04283253
Start Date
October 22 2019
End Date
March 31 2020
Last Update
March 3 2022
Active Locations (1)
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1
VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, United States, 15213