NCT06541041 Nerve Transfers Plus Electrical Stimulation to Improve Hand Function in Cervical Spinal Cord Injury
| NCT ID | NCT06541041 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Stanford University |
| Condition | Cervical Spinal Cord Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-02-10 |
| Primary Completion | 2028-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 10 participants in total. It began in 2025-02-10 with a primary completion date of 2028-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 cervical spinal cord injuries. Researchers will prospectively enroll patients with cervical spinal cord injury and no hand function who will undergo standard of care nerve transfer surgery combined with standard of care brief intraoperative electrical stimulation and temporary postoperative electrical stimulation. Motor and pain outcomes will be compared to a retrospective group of patients who underwent nerve transfer surgery without intraoperative or postoperative electrical stimulation. Participants will receive standard medical care (nothing experimental) as part of this study. Participants will: * Have a preoperative assessment including physical examination, electrodiagnostic studies, functional electrical stimulation, and will complete questionnaires assessing function and quality of life * Agree upon a surgical plan, including the specific nerve transfers to be performed and whether to include brief intraoperative electrical stimulation and/or temporary postoperative electrical stimulation before being considered for enrollment in the study * Will undergo standard of care nerve transfer surgery, with at least one nerve transfer targeting improvement in hand function and will receive brief intraoperative electrical stimulation of the donor nerves and placement of a temporary peripheral nerve stimulator * Will follow-up with the surgeon 3, 6, 12, 24, and 36 months after the surgery * Will have a physical examination and will complete questionnaires at the postoperative visits * Will participate in hand therapy following the operation * Will be eligible for placement of a permanent peripheral nerve stimulator, depending on response to the temporary peripheral nerve stimulator.
Eligibility Criteria
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
Contact & Investigator
Thomas J Wilson, MD, MPH
PRINCIPAL INVESTIGATOR
Stanford University
Frequently Asked Questions
Who can join the NCT06541041 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Cervical Spinal Cord Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06541041 currently recruiting?
Yes, NCT06541041 is actively recruiting participants. Contact the research team at wilsontj@stanford.edu for enrollment information.
Where is the NCT06541041 trial being conducted?
This trial is being conducted at Palo Alto, United States.
Who is sponsoring the NCT06541041 clinical trial?
NCT06541041 is sponsored by Stanford University. The principal investigator is Thomas J Wilson, MD, MPH at Stanford University. The trial plans to enroll 10 participants.