Evaluation of Electrical Stimulation During Nerve Transfer Surgery for Cervical Spinal Cord Injury

Status: Recruiting
Location: See location...
Intervention Type: Device
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 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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• Cervical spinal cord injury, ASIA A or ASIA B

• International Standards for Neurological Classification of Spinal Cord Injury neurological level of injury C6 or C7

• 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

• Age 18-65 years

• Mentally and physically able to comply with evaluations and assessments

• 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

• Muscle grade at least 4+/5 on the Medical Research Council (MRC) scale in the territory of the donor nerve(s)

• Stable function for at least 3 months (i.e., no ongoing recovery)

• Non-operative rehabilitation for at least 3 months

⁃ Able to read and write in English at a level necessary to complete the questionnaires

Locations
United States
California
Stanford University/Stanford Health Care
RECRUITING
Palo Alto
Contact Information
Primary
Thomas J Wilson, MD, MPH
wilsontj@stanford.edu
650-723-6469
Backup
Adrian Valladarez
adrian98@stanford.edu
Time Frame
Start Date: 2025-02-10
Estimated Completion Date: 2028-09
Participants
Target number of participants: 10
Treatments
Arm A: Standard nerve transfer surgery without electrical stimulation
This is a retrospective group that has already undergone standard nerve transfer surgery targeting hand function without intraoperative or postoperative electrical stimulation. No additional patients will be enrolled in this group.
Arm B: Standard nerve transfer surgery plus intraoperative and postoperative electrical stimulation
This is a prospectively enrolled group that will undergo standard nerve transfer surgery targeting hand function plus brief intraoperative electrical stimulation of the donor nerves and placement of a temporary peripheral nerve stimulator to allow postoperative electrical stimulation of the donor nerves for up to 60 days. All care provided, including the surgery, intraoperative electrical stimulation, postoperative electrical stimulation, and postoperative hand therapy, will be provided according to standard of care and is not considered experimental.
Related Therapeutic Areas
Sponsors
Collaborators: United States Department of Defense
Leads: Stanford University

This content was sourced from clinicaltrials.gov