Nerve Transfer to Improve Function in High Level Tetraplegia

Wilson Z. Ray30 enrolled

Overview

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.

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)

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cervical Spinal Cord Injury Tetraplegia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (10)

Stanford University

Stanford, California, United States

RECRUITING

University of Miami

Miami, Florida, United States

RECRUITING

Outcomes

Primary Outcomes

Elbow Dynamometry

Change from baseline to 36-48 months post-surgery. Elbow dynamometer measures muscle strength using a handheld portable dynamometer

Time frame: 36-48 months post-surgery

Spinal Cord Independence Measure

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.

Time frame: 36-48 months post-surgery

Motor strength in medical research council grade (MRC)

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.

Time frame: 36-48 months post-surgery

Electrodiagnosis (Nerve Conduction Study and Electromyography

Change in baseline to 36-48 Months post-surgery. NCS/EMG evaluate neuromuscular health and inform the integrity of lower motor neurons.

Time frame: 36-48 months post-surgery

Secondary Outcomes

Canadian Outcomes Performance Measure (COPM)

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.

Time frame: 36-48 Months post-surgery

Central Contacts

Linda Koester, BS

CONTACT

314-362-7368 koesterl@wustl.edu

Data from ClinicalTrials.gov

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