Nerve Transfer to Improve Function in High Level Tetraplegia

Status Recruiting

Clinical Trial 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.

Clinical Trial 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) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06288763
Study type	Observational
Source	Washington University School of Medicine
Contact	Linda Koester, BS
Phone	314-362-7368
Email	koesterl@wustl.edu
Status	Recruiting
Phase
Start date	February 5, 2024
Completion date	December 31, 2028

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.