Cervical Spinal Cord Injury, Tetraplegia
Conditions
Keywords
Spinal Cord Injury, Cervical spinal cord injury, Nerve Transfer Surgery, High Cervical Spinal Cord Injury, Cervical SCI, Tetraplegia, Quadriplegia, Nerve transfer, Spinal Accessory Nerve
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)
Interventions
None listed
Sponsors
Washington University School of Medicine
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
Department of Defense / Congressionally Mandated Research Program (CDMRP)
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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.. |
| 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. |
| 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. |
| 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. |
Countries
Canada, United States
Contacts
CONTACTLinda Koester, BS
PRINCIPAL_INVESTIGATORWilson Z. Ray, MD
Washington University School of Medicine
Outcome results
None listed