Intraoperative Peripheral Nerve Stimulation

Intraoperative Electrical Stimulation to Accelerate Functional Recovery of Peripheral Nerves After Decompressive Surgery

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Compression Neuropathy
• Intervention / Treatment: Device: Nerve Root Electrical Stimulation; Device: Peripheral Nerve Electrical Stimulation; Other: Standard Treatment - Nerve Root; Other: Standard Treatment - Peripheral Nerve

Detailed Description

The overall objective of this study is to establish the safety and utility of direct electrical stimulation as part of surgical intervention for compressive neuropathies of peripheral nerves and nerve roots. Stimulation will be provided with the Checkpoint Guardian which is a single-use, hand-held device cleared for the stimulation of exposed motor nerves or muscle tissue to locate and identify nerves. The central hypothesis is that electrical stimulation of the peripheral nerve or spinal nerve root at the time of decompressive surgery will improve motor strength and functional outcomes for patients.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wendy Jenkins, BSN RN, CCRC; Phone Number: 336-716-3842; Email: Wendy.jenkins@advocatehealth.org

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Atrium Health Wake Forest Baptist
      • Contact: Wendy Jenkins, BSN RN, CCRC; Phone Number: 336-716-3842; Email: Wendy.jenkins@advocatehealth.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nerve Root Stimulation Arm; patients undergoing spine surgery for decompression of the nerve root	Device: Nerve Root Electrical Stimulation; 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
Experimental: Peripheral Nerve Stimulation Arm; patients undergoing peripheral nerve decompression in an upper extremity	Device: Peripheral Nerve Electrical Stimulation; 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
Active Comparator: Nerve Root Control Arm; patients undergoing spine surgery for decompression of the nerve root	Other: Standard Treatment - Nerve Root; standard surgical treatment when undergoing spine surgery for decompression of the nerve root
Active Comparator: Peripheral Nerve Control Arm; patients undergoing peripheral nerve decompression in an upper extremity	Other: Standard Treatment - Peripheral Nerve; standard surgical treatment when undergoing peripheral nerve decompression in an upper extremity

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index Score	Participants in the nerve root stimulation arm will be given the The Oswestry Disability Index which is a self-administered questionnaire used to measure permanent functional disability caused by low back pain. It consists of 10 items covering pain and physical activities, with scores ranging from 0 (no disability) to 100 (maximum disability).	Baseline, Month 1, Month 3, Year 1
Patient Reported Outcomes Measurement Information System (PROMIS) Score	Score range from 20-80 with high scores indicating better function while lower scores indicate poorer function.	Baseline, Month 1, Month 3, Year 1
Disabilities of the Arm Shoulder and Hand Score	Participants in the peripheral nerve stimulation arm will be given the Disabilities of the Arm Shoulder and Hand questionnaire which is a 30-item self-reported questionnaire in which the response options are presented as 5-point Likert scales. Scores range from 0 (no disability) to 100 (most severe disability).	Baseline, Month 1, Month 3, Year 1
Short Form Health Survey Score	Participants in the peripheral nerve stimulation arm will be given the SF-36. There are 36 items with score range from 0-100 with a higher score indicating a better functional state with few limitations/disabilities while a low score indicates a poorer functional state with more disability and limitations.	Baseline, Month 1, Month 3, Year 1

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Christopher Dibble, MD, Atrium Health Wake Forest Baptist

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: May 11, 2026
• First Submitted That Met QC Criteria: May 11, 2026
• First Posted (Actual): May 18, 2026

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: electrical stimulation; peripheral nerves; decompressive surgery
• Additional Relevant MeSH Terms: Tomaculous neuropathy
• Other Study ID Numbers: IRB00149854

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No