--- title: Nerve Transfer to Improve Function in High Level Tetraplegia nct_id: NCT06288763 overall_status: RECRUITING sponsor: Washington University School of Medicine study_type: OBSERVATIONAL primary_condition: Cervical Spinal Cord Injury countries: United States, Canada canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06288763.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06288763" ct_last_update_post_date: 2026-03-11 last_seen_at: "2026-05-12T06:38:20.385Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # Nerve Transfer to Improve Function in High Level Tetraplegia **Official Title:** Nerve Transfer to Restore Upper Limb Function and Quality of Life in High Tetraplegia **NCT ID:** [NCT06288763](https://clinicaltrials.gov/study/NCT06288763) ## Key Facts - **Status:** RECRUITING - **Study Type:** OBSERVATIONAL - **Target Enrollment:** 30 - **Lead Sponsor:** Washington University School of Medicine - **Collaborators:** University of Michigan, The Methodist Hospital Research Institute, University of Pennsylvania, University of Utah, Stanford University, University of Miami, Johns Hopkins University, University of Alberta, Wake Forest University Health Sciences, Congressionally Directed Medical Research Programs - **Conditions:** Cervical Spinal Cord Injury, Tetraplegia - **Start Date:** 2024-02-05 - **Completion Date:** 2028-12-31 - **CT.gov Last Update:** 2026-03-11 ## 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. ## 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 - **Minimum age:** 18 Years - **Maximum age:** 80 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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 ``` ## Primary Outcomes - **Elbow Dynamometry** _(time frame: 36-48 months post-surgery)_ — Change from baseline to 36-48 months post-surgery. Elbow dynamometer measures muscle strength using a handheld portable dynamometer - **Spinal Cord Independence Measure** _(time frame: 36-48 months post-surgery)_ — Change from baseline to 36-48 months post-surgery. SCIM addresses three specific areas of function in patients with SCI, 1) Self-care (feeding, grooming, bathing, and dressing), 2) respiration and sphincter management, and 3) patient's mobility abilities (transfers from bed and indoors/outdoors). SCIM guide clinicians in determining treatment goals/objectives for SCI patients helping therapists assess measurable outcomes in their functional independence. Scores range from 0-100 with a higher score representing better function. - **Motor strength in medical research council grade (MRC)** _(time frame: 36-48 months post-surgery)_ — Change in baseline to 36-48 Months post-surgery. The manual muscle testing is a reliable measure of motor strength when assessed by a trained examiner. Scores range from 0-5, with the highest number representing a better score. - **Electrodiagnosis (Nerve Conduction Study and Electromyography** _(time frame: 36-48 months post-surgery)_ — Change in baseline to 36-48 Months post-surgery. NCS/EMG evaluate neuromuscular health and inform the integrity of lower motor neurons. ## Secondary Outcomes - **Canadian Outcomes Performance Measure (COPM)** _(time frame: 36-48 Months post-surgery)_ - **Capabilities of Upper Extremity Questionnaire (CUE-Q)** _(time frame: 36-48 Months post-surgery)_ - **Modified Ashworth Scale (MAS)** _(time frame: 36-48 Months post-surgery)_ - **Spinal Cord Injury Quality of LIfe Questionnaire** _(time frame: 36-48 Months post-surgery)_ - **International SCI Pain Basic Dataset (ISCIPBDS)** _(time frame: 36-48 Months post-surgery)_ ## Locations (10) - 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_ ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `sponsor.collaborators` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.stanford university|stanford|california|united states` — added _(2026-05-12)_ - `locations.university of miami|miami|florida|united states` — added _(2026-05-12)_ - `locations.johns hopkins university|baltimore|maryland|united states` — added _(2026-05-12)_ - `locations.university of michigan|ann arbor|michigan|united states` — added _(2026-05-12)_ - `locations.washington university in st. louis|st louis|missouri|united states` — added _(2026-05-12)_ - `locations.wake forest medical center|winston-salem|north carolina|united states` — added _(2026-05-12)_ - `locations.university of pennsylvania|philadelphia|pennsylvania|united states` — added _(2026-05-12)_ - `locations.houston methodist|houston|texas|united states` — added _(2026-05-12)_ - `locations.university of utah|salt lake city|utah|united states` — added _(2026-05-12)_ - `locations.university of alberta|edmonton|alberta|canada` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT06288763.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT06288763* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*