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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
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
Primary outcome measure(s)
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.
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.
Trial sites (10)
Facility
City
Region
Status
Stanford University
Stanford
California
Recruiting
University of Miami
Miami
Florida
Recruiting
Johns Hopkins University
Baltimore
Maryland
Recruiting
University of Michigan
Ann Arbor
Michigan
Recruiting
Washington University in St. Louis
St Louis
Missouri
Recruiting
Wake Forest Medical Center
Winston-Salem
North Carolina
Recruiting
University of Pennsylvania
Philadelphia
Pennsylvania
Recruiting
Houston Methodist
Houston
Texas
Recruiting
University of Utah
Salt Lake City
Utah
Recruiting
University of Alberta
Edmonton
Alberta
Not Yet Recruiting
More Washington University School of Medicine trials in Canada
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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