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Nerve Transfers Plus Electrical Stimulation to Improve Hand Function in Cervical Spinal Cord Injury

Recruitingn/aAges 18 Years - 65 YearsAllStanford University
NCT06541041 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 cervical spinal cord injuries. Researchers will prospectively enroll patients with cervical spin

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📋 Eligibility rules (as published)
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 grade at least 4+/5 on the Medical Research Council (MRC) scale in the territory of the donor nerve(s) 8. Stable function for at least 3 months (i.e., no ongoing recovery) 9. Non-operative rehabilitation for at least 3 months 10. Able to read and write in English at a level necessary to complete the questionnaires Exclusion Criteria: 1. Contraindication to electrical stimulation, including any implanted electronic device such as a pacemaker or intrathecal drug delivery pump 2. Active infection at the operative site or systemic infection 3. Active malignancy 4. Pregnancy 5. Joint contractures or limited passive range of motion that would limit recovery of function 6. Lack of appropriate social support and/or infrastructure to commit to scheduled follow-up visits 7. Previous tendon transfer or other surgery for restoration of function following cervical spinal cord injury 8. Planned tendon transfer surgery or other surgery for restoration of function following cervical spinal cord injury
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What it tests

  • Brief intraoperative electrical stimulation
  • Temporary Postoperative Peripheral Nerve Stimulation
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Where

1 site
Stanford University/Stanford Health Care
Palo Alto, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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