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Clinical Trials in Canada / NCT04023591
Active, not recruiting Observational

Nerve Transfer After Spinal Cord Injury- Multi-center

NCT04023591 · tracked via the Priya Life Science Canada tracker
Phase
Observational
Started
2020-04-13
Last updated
2026-06-17

Condition(s) studied

TetraplegiaSpinal Cord InjuriesQuadriplegia Flaccid

Investigational drug(s) / intervention(s)

Surgery/Occupational Therapy

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)

Trial sites (9)

FacilityCityRegionStatus
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

More Washington University School of Medicine trials in Canada

Other trials for the same condition

Official registry record

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.

View NCT04023591 on ClinicalTrials.gov ↗ ← All trials in Canada