Nerve Transfer to Improve Function in High Level Tetraplegia
Start Date
2/5/2024
Completion Date
12/31/2028
Summary
The goal of this observational study is to determine if nerve transfer surgeries improve upper extremity function and quality of life in patients with a high level cervical spinal cord injury. Participants will: * undergo standard of care pre- and post-op testing and study exams * complete pre- and post-questionnaires * undergo standard of care nerve transfer surgeries * follow-up with surgeon at 6/12/18/24/36 and potentially at 48 months * attend therapy at local therapist for up to 2 years postop.
Detailed Description
Restoration of function in patients with high tetraplegia has been an elusive clinical challenge. There is a critical need to find an effective reconstructive therapy/procedure which improves the upper extremity function in patients with high tetraplegia. One pure motor nerve - spinal accessory nerve (SAN) remains a viable donor in high tetraplegia patients to successfully restore elbow flexion or extension. Elbow function can provide profound independence in mobility, ventilator management and may broaden the application of assistive therapies. The two objectives of this study are: * Determine if SAN nerve transfer surgery can improve the reinnervation of bicep or tricep muscles in high tetraplegia patients. * Determine if SAN nerve transfer surgery can reanimate upper arm function and improve functional independence in patients with high tetraplegia. Study Activities (including standard of care (SOC)) * Electrodiagnosis pre-op (SOC) * Upper extremity maximum muscle testing (SOC) * Questionnaires (SOC and study-related (SR)) * Exams by a study therapist (SR) * Neurological exam - ISNCSCI - (SOC) * Nerve Transfer Surgery to be determined by surgeon (SOC) * Follow-up visits with surgeon at 6/12/18/24/36 and potentially 48 months * post-op electrodiagnostic testing (SR) * post-op upper extremity maximum muscle testing (SOC) * post-op questionnaires * post-op therapy exams (SR)
Eligibility Criteria
Age Range: 18 years to 80 years
Conditions
Locations
Stanford University
Stanford, California 94305
United States
University of Miami
Miami, Florida 33136
United States
Johns Hopkins University
Baltimore, Maryland 21287
United States
University of Michigan
Ann Arbor, Michigan 48109
United States
Washington University in St. Louis
St Louis, Missouri 63110
United States
Wake Forest Medical Center
Winston-Salem, North Carolina 27157
United States
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
Houston Methodist
Houston, Texas 77030
United States
University of Utah
Salt Lake City, Utah 84132
United States
University of Alberta
Edmonton, Alberta T6G-2E1
Canada