NCT05638191 Nerve Transfer Surgery to Restore Upper-limb Function After Cervical Spinal Cord Injury
| NCT ID | NCT05638191 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of British Columbia |
| Condition | Spinal Cord Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2021-06-03 |
| Primary Completion | 2028-01 |
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 40 participants in total. It began in 2021-06-03 with a primary completion date of 2028-01.
⚠ 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 prospective, open-label cohort study is to assess functional outcomes in individuals with cervical spinal cord injury who have undergone nerve transfer surgery to restore upper limb function. The main questions it aims to answer are: * Does nerve transfer improve hand function in individuals with cervical spinal cord injury? * What factors are associated with functional improvement following nerve transfer? Researchers will compare functional outcomes at 24 months post-surgery to 1) baseline outcomes and 2) individuals with cervical spinal cord injury who did not undergo nerve transfer. Participants who have received nerve transfer surgery as part of their regular medical care will complete functional hand tests, electrodiagnostic assessments, and questionnaires on independence and mood every 3 months for 24 months after surgery.
Eligibility Criteria
Inclusion Criteria: * Traumatic, motor-complete cervical SCI (AIS A or B) * Male or female, ages 18-70 * Consent and plan to undergo nerve transfer to restore grasp function in at least one limb * Motor grade 4-5 at C5 * Motor grade 0-1 at C8/T1 * Injury duration within 6 months at the time of surgery * English-speaking and cognitively intact * Able to provide informed written consent * Able to attend and comply with the testing protocols Exclusion Criteria: * Inability or unwillingness to participate in post-operative rehabilitation (in person or virtual) * Secondary complication of SCI (e.g., intractable neuropathic pain, edema, contracture) or major medical comorbidity (e.g., traumatic brain injury) that would independently influence response to surgery or ability to participate in rehabilitation
Contact & Investigator
Michael Berger, MD, PHD
PRINCIPAL INVESTIGATOR
University of British Columbia
Frequently Asked Questions
Who can join the NCT05638191 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying 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 NCT05638191 currently recruiting?
Yes, NCT05638191 is actively recruiting participants. Contact the research team at michael.berger@vch.ca for enrollment information.
Where is the NCT05638191 trial being conducted?
This trial is being conducted at Vancouver, Canada, Halifax, Canada, Kingston, Canada, Toronto, Canada.
Who is sponsoring the NCT05638191 clinical trial?
NCT05638191 is sponsored by University of British Columbia. The principal investigator is Michael Berger, MD, PHD at University of British Columbia. The trial plans to enroll 40 participants.