Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Active Not Recruiting NCT04023591

Nerve Transfer After Spinal Cord Injury- Multi-center

Conditions: Tetraplegia, Spinal Cord Injuries, Quadriplegia Flaccid

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Enrollment: 70
Sponsor: Washington University School of Medicine

Location: Stanford University Stanford California

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 Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04023591). StuddyBuddy aggregates publicly available trial information.