Nerve transfer surgery to enhance function in high tetraplegia
Nerve Transfer to Restore Upper Limb Function and Quality of Life in High Tetraplegia
This study is testing if nerve transfer surgery can help people with high spinal cord injuries improve their arm function and quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 10 sites (Stanford, California and 9 other locations) |
| Trial ID | NCT06288763 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of nerve transfer surgeries in improving upper extremity function and quality of life for patients with high cervical spinal cord injuries. Participants will undergo standard pre- and post-operative testing, complete questionnaires, and receive nerve transfer surgeries as part of their standard care. Follow-up assessments will occur at multiple intervals over a period of up to four years to monitor recovery and functional improvements. The study focuses on the spinal accessory nerve as a potential donor nerve to restore elbow function, which is crucial for independence in daily activities.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with high cervical spinal cord injuries (C1-C4) who have plateaued in recovery and meet specific strength and health criteria.
Not a fit: Patients with ongoing recovery of motor function, significant joint contractures, or those who are immunocompromised may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance upper limb function and independence for patients with high tetraplegia.
How similar studies have performed: While nerve transfer surgeries have shown promise in other studies, this specific approach targeting high tetraplegia is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-80 years of age * High cervical SCI (motor level C1-C4) * Motor complete SCI AIS grade A-B * Plateaued spontaneous recovery for at least 6 months of non-operative therapy * SCI greater than 6 months and fewer than 60 months since injury * At least MRC 4/5 donor strength * Mentally and physically willing and able to comply with evaluations Exclusion Criteria: * Active infection at the operative site or systemic infection * Any return or ongoing recovery of distal motor function * Significant joint contractures and/or limitations in passive range of motion in the arm * Mentally or physically compromised making it impossible to complete study activities * Immunologically suppressed * Currently undergoing long-term steroid therapy * Active malignancy * Pregnancy
Where this trial is running
Stanford, California and 9 other locations
- Stanford University — Stanford, California, United States (Recruiting)
- University of Miami — Miami, Florida, United States (Recruiting)
- Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
- University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
- Washington University in St. Louis — St Louis, Missouri, United States (Recruiting)
- Wake Forest Medical Center — Winston-Salem, North Carolina, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Houston Methodist — Houston, Texas, United States (Recruiting)
- University of Utah — Salt Lake City, Utah, United States (Recruiting)
- University of Alberta — Edmonton, Alberta, Canada (Not_yet_recruiting)
Study contacts
- Principal investigator: Wilson Z. Ray, MD — Washington University School of Medicine
- Study coordinator: Linda Koester, BS
- Email: koesterl@wustl.edu
- Phone: 314-362-7368
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.