Status:
COMPLETED
A Novel Brain Stimulation for Bimanual Motor Function and Control in Chronic Stroke
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
American Heart Association
Conditions:
Stroke
Eligibility:
All Genders
18-90 years
Phase:
EARLY_PHASE1
Brief Summary
The long-term goal of this project is to develop and test upper Iimb rehabilitation interventions that can improve bimanual motor function, or the ability to use both arms and hands together, for stro...
Detailed Description
In a pilot randomized controlled clinical trial, 18 stroke survivors more than 6 months after stroke onset, and have upper limb impairment will be enrolled. Participants will be randomized to receive ...
Eligibility Criteria
Inclusion
- Age 18-90 yrs
- ≥6 months since first clinical stroke
- Impairment of the paretic hand, indicated by a score of \<= 11 out of 14 on the hand section of UEFM
- Sufficient range of motion in the wrist and fingers for functional task practice: have at least 10 degrees active wrist extension, 10 degrees active thumb abduction/extension, and 10 degrees active extension in at least 2 additional digits
- Sufficient active shoulder and elbow movement to volitionally position the paretic hand in the workspace for table-top task practice
Exclusion
- Brainstem or cerebellar stroke
- Bilateral strokes or multiple strokes affecting sensorimotor structures
- Cognitive impairment (Mini-Mental State Examination \<24)
- Severe impairment of the paretic hand that limits functional task practice (UEFM hand score \< 4 out of 14)
- Severe spasticity (Modified Ashworth Scale \>3) or upper limb contracture
- Occupational therapy or upper limb Botox completed ≤ 2 months prior
- Contraindications to TMS or MRI (e.g. metal implant in head, seizure history, cardiac pacemaker)
Key Trial Info
Start Date :
March 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2024
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT05381740
Start Date
March 8 2022
End Date
January 1 2024
Last Update
June 3 2024
Active Locations (1)
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1
Lerner Research Institute, Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195