Status:
COMPLETED
Spinal Cord Stimulation for Restoration of Arm and Hand Function in People With Subcortical Stroke
Lead Sponsor:
Lee Fisher, PhD
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Stroke
Brain Diseases
Eligibility:
All Genders
21-70 years
Phase:
NA
Brief Summary
The goal of this study is to verify whether electrical stimulation of the cervical spinal cord can activate muscles of the arm and hand in people with hemiplegia following stroke. Participants will un...
Detailed Description
Specifically, researchers will 1) quantify the motor potentials in arm and hand muscles generated by single pulses of electrical stimulation of the spinal cord using FDA-cleared devices 2) characteriz...
Eligibility Criteria
Inclusion
- Single, ischemic or hemorrhagic stroke resulting in upper extremity hemiparesis more than 6 months prior to the time of enrollment. (Prior strokes that did not cause upper extremity motor deficits are not exclusionary.)
- Participants must be between the ages of 21 and 70 years old.
- Scores higher than 7 and lower than 50 on the Fugl-Meyer scale
Exclusion
- Serious disease or disorder (ex. neurological condition other than stroke, cancer, severe cardiac or respiratory disease, renal failure, etc.) or cognitive impairments that could affect the ability to participate in study activities.
- Pregnancy or breast feeding.
- Receiving anticoagulant, anti-spasticity or anti-epileptic medications throughout the duration of the study.
- Presence of any implanted medical devices.
- Severe claustrophobia.
- Presence of joint contractures deemed by study clinician/investigator to be too severe to participate in study activities
- Results from the Brief Symptoms Inventory (BSI-18) and additional discussions with the Principal Investigator and a study physician that deem participant inappropriate for the study.
- Evaluation to sign consent form score \<12.
Key Trial Info
Start Date :
March 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04512690
Start Date
March 24 2021
End Date
June 30 2025
Last Update
August 11 2025
Active Locations (1)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213