Nerve Transfer After Spinal Cord Injury- Multi-center

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Trial ID: NCT04023591

Purpose

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.

Official Title

Nerve Transfers to Improve Upper Extremity Function and Quality of Life in Tetraplegic Patients

Stanford Investigator(s)

Thomas J. Wilson
Thomas J. Wilson

Clinical Associate Professor, Neurosurgery

Eligibility


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.

Intervention(s):

procedure: Surgery/Occupational Therapy

Recruiting

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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Thomas J Wilson, MD
650-723-0320