Status:
RECRUITING
Transcutaneous Spinal Stimulation: Safety and Feasibility for Upper Limb Function in Children With Spinal Cord Injury
Lead Sponsor:
University of Louisville
Collaborating Sponsors:
The Jewish Heritage Foundation for Excellence
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
4-18 years
Phase:
NA
Brief Summary
Children who suffer a spinal cord injury in the neck region have difficulty using their hands due to paralysis and/or weakness of their arms and hand muscles. The purpose of this project is to test th...
Detailed Description
Adults with cervical spinal cord injury (SCI) rank gaining arm and hand function as the highest priority for improving their quality of life. Children with SCI, similarly experience paralysis of hand ...
Eligibility Criteria
Inclusion
- history of chronic, acquired SCI, (\>1 year since injury);
- SCI involves cervical and/or high thoracic (T1) levels
- moderate to severe upper extremity deficit as assessed by the Pediatric Neuromuscular Recovery Upper Extremity Scale (scores less than 4A out of a 12 point range from 1A-4C on upper extremity tasks, e.g. including inability to fully reach overhead, grasp, or pinch without compensation)
- discharged from in-patient rehabilitation
Exclusion
- botox use within past 3 months;
- current baclofen use
- unhealed upper extremity fracture
- any other medical complication limiting participation in the assessments and/or activity- based upper extremity training;
- congenital SCI
- total ventilator dependence
Key Trial Info
Start Date :
November 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04032990
Start Date
November 14 2019
End Date
February 1 2026
Last Update
June 24 2024
Active Locations (1)
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1
Department of Neurosurgery
Louisville, Kentucky, United States, 40202