Nerve Transfer to Improve Function in High Level Tetraplegia
- Conditions
- Cervical Spinal Cord InjuryTetraplegia
- Registration Number
- NCT06288763
- Lead Sponsor
- Washington University School of Medicine
- 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)
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Motor strength in medical research council grade (MRC) 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.
Elbow Dynamometry 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 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.
Electrodiagnosis (Nerve Conduction Study and Electromyography 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 Outcome Measures
Name Time Method Modified Ashworth Scale (MAS) 36-48 Months post-surgery Change from baseline to 36-48 months post-surgery. MAS is a reliable measure for rating spasticity in SCI. Scores range from 0-32 with higher scores reflecting better function.
Canadian Outcomes Performance Measure (COPM) 36-48 Months post-surgery Change from baseline to 36-48 months post-surgery. COPM is a validated outcome measure for SCI patients focusing on occupational performance in all areas of life. Scores range from 5-50 for performance and satisfaction. The higher scores reflect better performance and satisfaction.
Capabilities of Upper Extremity Questionnaire (CUE-Q) 36-48 Months post-surgery Change from baseline to 36-48 months post-surgery. CUE-Q detects changes in upper extremity function. Scores range from 32-224 with higher scores reflecting better function.
Spinal Cord Injury Quality of LIfe Questionnaire 36-48 Months post-surgery Change from baseline to 36-48 months post-surgery. SCI-QOL is designed to measure subjective quality of life in terms of satisfaction and importance. Range of scores is 0 to 30 with the higher scores reflecting a better quality of life..
International SCI Pain Basic Dataset (ISCIPBDS) 36-48 Months post-surgery Change from baseline to 36-48 months post-surgery. ISCIPBDS correctly classifies pain, determines its intensity and broad impact on daily activities. Lower scores reflect less pain/less interference in daily life.
Trial Locations
- Locations (10)
Stanford University
🇺🇸Stanford, California, United States
University of Miami
🇺🇸Miami, Florida, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Washington University in St. Louis
🇺🇸Saint Louis, Missouri, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Houston Methodist
🇺🇸Houston, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
University of Calgary - Alberta Health Services
🇨🇦Calgary, Alberta, Canada
University of Alberta
🇨🇦Edmonton, Alberta, Canada