Recruiting

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

Sponsor:

Stanford University

Code:

NCT06541041

Conditions

Cervical Spinal Cord Injury

Cervical Spinal Cord Paralysis

Tetraplegia

Tetraplegia/Tetraparesis

Tetraplegic Spinal Paralysis

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Brief intraoperative electrical stimulation

Temporary Postoperative Peripheral Nerve Stimulation

Study Details

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

Study ID

NCT06541041

Start date

Feb 10, 2025

Status verified date

Feb, 2025

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Cervical spinal cord injury, ASIA A or ASIA B
2. International Standards for Neurological Classification of Spinal Cord Injury neurological level of injury C6 or C7
3. 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
4. Age 18-65 years
5. Mentally and physically able to comply with evaluations and assessments
6. 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
7. Muscle grade at least 4+/5 on the Medical Research Council (MRC) scale in the territory of the donor nerve(s)
8. Stable function for at least 3 months (i.e., no ongoing recovery)
9. Non-operative rehabilitation for at least 3 months
10. Able to read and write in English at a level necessary to complete the questionnaires

Exclusion Criteria:

1. Contraindication to electrical stimulation, including any implanted electronic device such as a pacemaker or intrathecal drug delivery pump
2. Active infection at the operative site or systemic infection
3. Active malignancy
4. Pregnancy
5. Joint contractures or limited passive range of motion that would limit recovery of function
6. Lack of appropriate social support and/or infrastructure to commit to scheduled follow-up visits
7. Previous tendon transfer or other surgery for restoration of function following cervical spinal cord injury
8. Planned tendon transfer surgery or other surgery for restoration of function following cervical spinal cord injury

Study Design

Enrollment

10 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Brief intraoperative electrical stimulation

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

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.

Primary outcome measure

Composite Motor Score [ Time Frame: 36 Months Postoperative ]
Percentage of Baseline Pain [ Time Frame: 6 Months Postoperative ]

Central Contacts and Locations

Central contacts

Thomas J Wilson, MD, MPH

650-723-6469 wilsontj@stanford.edu

Adrian Valladarez

adrian98@stanford.edu

Locations

Stanford University/Stanford Health Care

Recruiting

Palo Alto, California, United States, 94304

Contacts

Thomas J Wilson, MD, MPH

650-723-6469 wilsontj@stanford.edu

Adrian Valladarez

adrian98@stanford.edu

Principal Investigator:

Thomas J Wilson, MD, MPH

More Information

Sponsor

Stanford University

Last update posted

Feb 19, 2025

Last verified

Feb, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Stanford University on 2025-02-19.