Improving hand function in cervical spinal cord injury with nerve transfers and electrical stimulation
Evaluation of Electrical Stimulation During Nerve Transfer Surgery for Cervical Spinal Cord Injury
Stanford University · NCT06541041
This study is testing if using electrical stimulation during and after nerve surgery can help people with cervical spinal cord injuries regain hand function and feel less pain.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Stanford University (other) |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT06541041 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of brief intraoperative electrical stimulation and temporary postoperative electrical stimulation in enhancing motor and pain outcomes for patients with cervical spinal cord injuries undergoing nerve transfer surgery. The study will enroll patients who have lost hand function due to cervical spinal cord injury and will assess the impact of these electrical stimulation techniques on their recovery. The researchers hypothesize that these interventions will lead to improved hand function and reduced pain compared to standard nerve transfer surgery alone.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 with cervical spinal cord injuries classified as ASIA A or B, who are scheduled for nerve transfer surgery targeting finger flexion and extension.
Not a fit: Patients with cervical spinal cord injuries who do not meet the eligibility criteria or have ongoing recovery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance hand function and reduce pain for patients with cervical spinal cord injuries.
How similar studies have performed: While nerve transfer surgery has shown promise in restoring hand function, the specific combination of electrical stimulation techniques used in this study has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Palo Alto, California
- Stanford University/Stanford Health Care — Palo Alto, California, United States (RECRUITING)
Study contacts
- Principal investigator: Thomas J Wilson, MD, MPH — Stanford University
- Study coordinator: Thomas J Wilson, MD, MPH
- Email: wilsontj@stanford.edu
- Phone: 650-723-6469
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cervical Spinal Cord Injury, Cervical Spinal Cord Paralysis, Tetraplegia, Tetraplegia/Tetraparesis, Tetraplegic Spinal Paralysis, Nerve Transfer, Brief Intraoperative Electrical Stimulation, Peripheral Nerve Stimulation