Intraoperative Peripheral Nerve Stimulation

NCT07592065 | Not Yet Recruiting FDA Device

• 1 other identifier: IRB00149854
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to find out if using direct electrical stimulation during surgery is safe and helpful for people with nerve problems caused by compressed nerves.

Conditions

Compression Neuropathy

Keywords

decompressive surgery; peripheral nerves; electrical stimulation

Outcome Measures

Primary Outcomes (4)

• Medical Research Council Scale for Muscle Strength Score

  The Medical Research Council Scale for Muscle Strength is a 0-to-5 point system that grades muscle power during physical examinations with a higher score indicating normal strength.

  Baseline

• Medical Research Council Scale for Muscle Strength Score

  The Medical Research Council Scale for Muscle Strength is a 0-to-5 point system that grades muscle power during physical examinations with a higher score indicating normal strength.

  Month 1

• Medical Research Council Scale for Muscle Strength Score

  The Medical Research Council Scale for Muscle Strength is a 0-to-5 point system that grades muscle power during physical examinations with a higher score indicating normal strength.

  Month 3

• Medical Research Council Scale for Muscle Strength Score

  The Medical Research Council Scale for Muscle Strength is a 0-to-5 point system that grades muscle power during physical examinations with a higher score indicating normal strength.

  Year 1

Secondary Outcomes (4)

• Oswestry Disability Index Score

  Baseline, Month 1, Month 3, Year 1

• Patient Reported Outcomes Measurement Information System (PROMIS) Score

  Baseline, Month 1, Month 3, Year 1

• Disabilities of the Arm Shoulder and Hand Score

  Baseline, Month 1, Month 3, Year 1

• Short Form Health Survey Score

  Baseline, Month 1, Month 3, Year 1

Study Arms (4)

Nerve Root Stimulation Arm

EXPERIMENTAL

patients undergoing spine surgery for decompression of the nerve root

Device: Nerve Root Electrical Stimulation

Peripheral Nerve Stimulation Arm

EXPERIMENTAL

patients undergoing peripheral nerve decompression in an upper extremity

Device: Peripheral Nerve Electrical Stimulation

Nerve Root Control Arm

ACTIVE COMPARATOR

patients undergoing spine surgery for decompression of the nerve root

Other: Standard Treatment - Nerve Root

Peripheral Nerve Control Arm

ACTIVE COMPARATOR

patients undergoing peripheral nerve decompression in an upper extremity

Other: Standard Treatment - Peripheral Nerve

Interventions

Nerve Root Electrical Stimulation DEVICE

in addition to standard of care surgical decompression will receive 10 minutes of electrical stimulation at an amplitude of 2 mA with the Checkpoint nerve stimulator to the nerve root at the time of decompressive surgery

Nerve Root Stimulation Arm

Peripheral Nerve Electrical Stimulation DEVICE

in addition to standard of care surgical decompression will receive 10 minutes of electrical stimulation at an amplitude of 2 mA with the Checkpoint nerve stimulator to the peripheral nerve at the time of decompressive surgery

Peripheral Nerve Stimulation Arm

Standard Treatment - Nerve Root OTHER

standard surgical treatment when undergoing spine surgery for decompression of the nerve root

Nerve Root Control Arm

Standard Treatment - Peripheral Nerve OTHER

standard surgical treatment when undergoing peripheral nerve decompression in an upper extremity

Peripheral Nerve Control Arm

Eligibility Criteria

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

You may qualify if:

• Nerve root stimulation arm: Clinical and radiographic findings of compressive neuropathy at the level of the nerve root, including myelopathy and/ or radiculopathy, who are planning for minimally invasive or open spine surgery to decompress the nerve.
• Peripheral nerve stimulation arm: Compressive peripheral neuropathy, including cubital tunnel, carpal tunnel and peroneal nerve compression who are planning to undergo surgical decompression in the affected upper extremity.

You may not qualify if:

• Patients that had previous nerve transfers for cervical spinal cord injury or tendon transfers, as they would not benefit from this procedure.
• Any implanted electronic devices, including pacemakers
• Pregnant or nursing

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Tomaculous neuropathy

Study Officials

• Christopher Dibble, MD

  Atrium Health Wake Forest Baptist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wendy Jenkins, BSN RN, CCRC

CONTACT

336-716-3842; Wendy.jenkins@advocatehealth.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: researcher measuring patient reported outcomes will be blinded to the treatment participants received
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2026
• First Posted: May 18, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: May 18, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)