Nerve Transfers Plus Electrical Stimulation to Improve Hand Function in Cervical Spinal Cord Injury

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT06541041
Status
Recruiting
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Conditions

  • Cervical Spinal Cord Injury
  • Cervical Spinal Cord Paralysis
  • Tetraplegia
  • Tetraplegia/Tetraparesis
  • Tetraplegic Spinal Paralysis

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Brief intraoperative electrical stimulation — DEVICE
    Intraoperative 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 — DEVICE
    An 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.

Study Details

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.

Key Dates

Start date
Feb 10, 2025
Status verified
Feb 2025
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
10 participants (estimated)

Arms

  • Arm: 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: 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.

Primary Outcome Measure

Composite Motor Score [ Time Frame: 36 Months Postoperative ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford University/Stanford Health CarePalo AltoCalifornia94304
Thomas J Wilson, MD, MPH
[email protected]
650-723-6469
Adrian Valladarez
[email protected]
Thomas J Wilson, MD, MPH (PRINCIPAL_INVESTIGATOR)

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