Status:
ACTIVE_NOT_RECRUITING
Nerve Transfer After Spinal Cord Injury- Multi-center
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
Stanford University
University of Pennsylvania
Conditions:
Tetraplegia
Spinal Cord Injuries
Eligibility:
All Genders
18-65 years
Brief 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 independe...
Detailed Description
Study Design and Feasibility: A prospective multi-institutional non-randomized single arm design will be utilized. Seventy subjects with cervical ASIA A-B (International Standards for Neurological Cla...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Age 18-65, inclusive
- At least 3 months of non-operative rehab therapy
- Mentally and physically willing and able to comply with evaluations
- Less than 36 months post-injury
- Stable ASIA scores with no evidence of functional improvement in motor or sensory examination for at least 3 months
- ASIA A or B determined by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI)
- EMG/NCS verifies intact innervation (normal CMAPs) to the paralyzed target muscles below the level of injury
- Functional electrical stimulation (FES) will be performed. Subject must have clinically normal MRC grade 5/5 donor (axonal) function
- Injury Level C4-C8
- Exclusion Criteria
- Active infection at the operative site or systemic infection
- Any return or ongoing clinical recovery of distal motor function
- Mentally or physically compromised that will prevent them from complying with evaluations.
- Immunologically suppressed
- Currently undergoing long-term steroid therapy
- Active malignancy
- Pregnant
- Significant joint contractures and/or limitations in passive range of motion in the arm or hand, per treating surgeon's discretion
- Lack of appropriate social support and/or infrastructure to commit to scheduled follow-up visits.
- Patients who are planning on undergoing a tendon transfer during the study period or who have had a tendon transfer in the past.
Exclusion
Key Trial Info
Start Date :
April 13 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT04023591
Start Date
April 13 2020
End Date
December 1 2026
Last Update
September 9 2025
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
Stanford University
Stanford, California, United States, 94305
2
University of Miami
Miami, Florida, United States, 33136
3
University of Michigan
Ann Arbor, Michigan, United States, 48109
4
Washington University
St Louis, Missouri, United States, 63110