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

NCT06541041 | Recruiting DMC FDA Device

• 1 other identifier: 75876
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Cervical Spinal Cord Injury; Nerve Transfer; Brief Intraoperative Electrical Stimulation; Peripheral Nerve Stimulation; Tetraplegia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Manual Motor Testing

  6, 12, and 24 Months Postoperative

• Percentage of Baseline Pain

  3 Weeks, 12, 24, and 36 Months Postoperative

• DASH Score

  6, 12, 24, and 36 Months Postoperative

• MHQ Score

  6, 12, 24, and 36 Months Postoperative

• SCIM III Score

  6, 12, 24, and 36 Months Postoperative

Study Arms (2)

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.

Device: Brief intraoperative electrical stimulation; Device: Temporary Postoperative Peripheral Nerve Stimulation

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.

Also known as: Checkpoint Guardian Nerve Stimulator

Arm B: Standard nerve transfer surgery plus intraoperative and postoperative electrical stimulation

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.

Also known as: SPRINT PNS System

Arm B: Standard nerve transfer surgery plus intraoperative and postoperative electrical stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cervical spinal cord injury patients aged 18-65 years with neurological level of injury C6 or C7 and limited or no hand function

You may qualify if:

• 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

You may not qualify if:

• 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
• Joint contractures or limited passive range of motion that would limit recovery of function
• Lack of appropriate social support and/or infrastructure to commit to scheduled follow-up visits
• Previous tendon transfer or other surgery for restoration of function following cervical spinal cord injury
• Planned tendon transfer surgery or other surgery for restoration of function following cervical spinal cord injury

Sponsors & Collaborators

• Stanford University: lead
• United States Department of Defense: collaborator

Study Sites (1)

Stanford University/Stanford Health Care

Palo Alto, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Quadriplegia

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas J Wilson, MD, MPH

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas J Wilson, MD, MPH

CONTACT

650-723-6469; wilsontj@stanford.edu

Adrian Valladarez

CONTACT

adrian98@stanford.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 3, 2024
• First Posted: August 7, 2024
• Study Start: February 10, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)