Nerve Transfers Plus Electrical Stimulation to Improve Hand Function in Cervical Spinal Co
The goal of this prospective observational study is to determine whether brief intraoperative electrical stimulation and temporary postoperative electrical stimulation improve motor and/or pain outcomes for patients with cervical spinal cord injury undergoing standard of care nerve transfer surgery to improve hand func
| Condition(s) | Cervical Spinal Cord Injury, Cervical Spinal Cord Paralysis, Tetraplegia, Tetraplegia/Tetraparesis, Tetraplegic Spinal Paralysis |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | The goal of this prospective observational study is to determine whether brief intraoperative electrical stimulation and temporary postoperative electrical stimulation improve motor and/or pain outcomes for patients with cervical spinal cord injury undergoing standard of care nerve transfer surgery to improve hand function. The main hypotheses include: Hypothesis #1: Brief intraoperative electrical stimulation of the donor nerves will result in improved motor outcomes (hand function) compared to standard nerve transfer surgery in patients with cervical spinal cord injuries. Hypothesis #2: Placement of a temporary peripheral nerve stimulator for 60 days of postoperative electrical stimulation will result in improved pain outcomes compared to standard nerve transfer surgery in patients with |
| Who can participate | Inclusion Criteria: 1. Cervical spinal cord injury, ASIA A or ASIA B 2. International Standards for Neurological Classification of Spinal Cord Injury neurological level of injury C6 or C7 3. Agreed upon surgical plan includes at least 1 nerve transfer targeting finger flexion with the anterior interosseous nerve as the recipient and at least 1 nerve transfer targeting finger extension with the posterior interosseous nerve as the recipient 4. Age 18-65 years 5. Mentally and physically able to comply with evaluations and assessments 6. Upper motor neuron pattern of injury in the recipient nerve with planned surgery 36 months or less from the time of injury OR lower motor neuron pattern of injury in the recipient nerve with planned surgery 9 months or less from the time of injury 7. Muscle gr |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | Stanford University |
| Locations | Palo Alto, California, United States |
| Start date | 2025-02-10 |
| NCT ID | NCT06541041 |
| Official listing | https://clinicaltrials.gov/study/NCT06541041 |