Nerve Transfers Plus Electrical Stimulation to Improve Hand Function in Cervical Spinal Cord Injury
NCT Number: NCT06541041
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Cervical Spinal Cord Injury|Cervical Spinal Cord Paralysis|Tetraplegia|Tetraplegia/Tetraparesis|Tetraplegic Spinal Paralysis
Interventions: DEVICE: Brief intraoperative electrical stimulation|DEVICE: Temporary Postoperative Peripheral Nerve Stimulation
Sponsor: Stanford University
Collaborators: United States Department of Defense
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-10
Completion Date: 2028-09
Locations: Stanford University/Stanford Health Care, Palo Alto, California, 94304, United States

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.

Primary Outcome Measures: Composite Motor Score, A composite sum of the manual motor testing of the extensor digitorum communis and flexor pollicis longus muscles on the MRC scale (0-5 for each muscle, 0-10 composite score) will be calculated (composite motor score)., 36 Months Postoperative|Percentage of Baseline Pain, The percentage of baseline pain in the operated limb will be calculated by dividing the postoperative NRS score by the baseline NRS score and multiplying by 100., 6 Months Postoperative
Secondary Outcome Measures: Manual Motor Testing, A composite sum of the manual motor testing of the extensor digitorum communis and flexor pollicis longus muscles on the MRC scale (0-5 for each muscle, 0-10 composite score) will be calculated (composite motor score)., 6, 12, and 24 Months Postoperative|Percentage of Baseline Pain, The percentage of baseline pain in the operated limb will be calculated by dividing the postoperative NRS score by the baseline NRS score and multiplying by 100., 3 Weeks, 12, 24, and 36 Months Postoperative|DASH Score, Patients will complete the Disabilities of the Arm, Shoulder, and Hand Questionnaire. The DASH score ranges from 0-100, with 0 representing normal function of the upper extremities and 100 representing maximal functional impairment., 6, 12, 24, and 36 Months Postoperative|MHQ Score, Patients will complete the Michigan Hand Questionnaire. The MHQ has a score range of 0-100, with 0 representing the worst hand function and 100 representing ideal hand function., 6, 12, 24, and 36 Months Postoperative|SCIM III Score, Patients will complete the Spinal Cord Independence Measure III Questionnaire. The SCIM III score ranges from 0-60, with 0 representing complete dependence and 60 representing complete independence., 6, 12, 24, and 36 Months Postoperative|Zung SDS, Patients will complete the Zung Self-rated Depression Scale Questionnaire. Zung SDS score ranges from 20-80, with normal (\<50), mild depression (50 to 59), moderate to marked major depression (60 to 69), and severe to extreme major depression (\>70)., 6, 12, 24, and 36 Months Postoperative