NCT06288763 Nerve Transfer to Improve Function in High Level Tetraplegia
| NCT ID | NCT06288763 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Washington University School of Medicine |
| Condition | Cervical Spinal Cord Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-02-05 |
| Primary Completion | 2028-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2024-02-05 with a primary completion date of 2028-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Wilson Z. Ray, MD
PRINCIPAL INVESTIGATOR
Washington University School of Medicine
Frequently Asked Questions
Who can join the NCT06288763 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Cervical Spinal Cord Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06288763 currently recruiting?
Yes, NCT06288763 is actively recruiting participants. Contact the research team at koesterl@wustl.edu for enrollment information.
Where is the NCT06288763 trial being conducted?
This trial is being conducted at Stanford, United States, Miami, United States, Baltimore, United States, Ann Arbor, United States and 6 additional locations.
Who is sponsoring the NCT06288763 clinical trial?
NCT06288763 is sponsored by Washington University School of Medicine. The principal investigator is Wilson Z. Ray, MD at Washington University School of Medicine. The trial plans to enroll 30 participants.