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.
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
Contraindication to electrical stimulation, including any implanted electronic device such as a pacemaker or intrathecal drug delivery pump
Active infection at the operative site or systemic infection
Active malignancy
Pregnancy
Cervical spinal cord injury patients aged 18-65 years with neurological level of injury C6 or C7 and limited or no hand function
Cohort
Other
Brief intraoperative electrical stimulation
DeviceIntraoperative brief electrical stimulation (BES) will be performed using a handheld nerve stimulator (Checkpoint Guardian) to stimulate the donor nerves at 2 mA with a 200 µs pulse duration for 10 minutes per nerve.
Temporary Postoperative Peripheral Nerve Stimulation
DeviceAn implantable temporary peripheral nerve stimulator (SPRINT PNS System) will be placed during the surgery with one lead for each donor nerve. The implantable peripheral nerve stimulator will be programmed to optimize postoperative pain control on an individualized basis. The peripheral nerve stimulator will be explanted after 60 days, as is intended for this device.
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).
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.
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).
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.
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.
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.
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Stanford University
Lead sponsor
United States Department of Defense
Collaborator
