Nerve Transfer After Spinal Cord Injury- Multi-center (NCT04023591) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Nerve Transfer After Spinal Cord Injury- Multi-center
United States70 participantsStarted 2020-04-13
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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
Exclusion criteria
✕. Active infection at the operative site or systemic infection