Surgery/Occupational Therapy: Surgery based on function and injury/ Occupational therapy for 48 months post-surgery
Study summary
Current treatment strategies of acute cervical spinal cord injuries remain limited. Treatment options that provide meaningful improvements in patient quality of like and long-term functional independence will provide a significant public health impact. Specific aim: Measure the efficacy of nerve transfer surgery in the treatment of patients with complete spinal cord injuries with no hand function. Optimize the efficiency of nerve transfer surgery by evaluating patient outcomes in relation to patient selection and quality of life and functional independence.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria
1. Age 18-65, inclusive
2. At least 3 months of non-operative rehab therapy
3. Mentally and physically willing and able to comply with evaluations
4. Less than 36 months post-injury
5. Stable ASIA scores with no evidence of functional improvement in motor or sensory examination for at least 3 months
6. ASIA A or B determined by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
7. EMG/NCS verifies intact innervation (normal CMAPs) to the paralyzed target muscles below the level of injury
8. Functional electrical stimulation (FES) will be performed. Subject must have clinically normal MRC grade 5/5 donor (axonal) function
9. Injury Level C4-C8
Exclusion Criteria
1. Active infection at the operative site or systemic infection
2. Any return or ongoing clinical recovery of distal motor function
3. Mentally or physically compromised that will prevent them from complying with evaluations.
4. Immunologically suppressed
5. Currently undergoing long-term steroid therapy
6. Active malignancy
7. Pregnant
8. Significant joint contractures and/or limitations in passive range of motion in the arm or hand, per treating surgeon's discretion
9. Lack of appropriate social support and/or infrastructure to commit to scheduled follow-up visits.
10. Patients who are planning on undergoing a tendon transfer during the study period or who have had a tendon transfer in the past.
Primary outcome measure(s)
Manual Motor Testing — 48 months Change from baseline testing strength of upper extremities at 48 months post-operatively
Handheld Dynamometry — 48 months Change from baseline grip strength at 48 months post-operatively
Trial sites (9)
Facility
City
Region
Status
Stanford University
Stanford
California
University of Miami
Miami
Florida
University of Michigan
Ann Arbor
Michigan
Washington University
St Louis
Missouri
University of Pennsylvania
Philadelphia
Pennsylvania
Houston Methodist
Houston
Texas
University of Utah
Salt Lake City
Utah
Alberta Health Services - Foothills Medical Center
Calgary
Alberta
University of Alberta
Edmonton
Alberta
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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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