Evaluate the Safety and Efficacy of a Peripheral Nerve Stimulation

A Prospective, Multicenter, Randomized Withdrawal Trial to Evaluate the Safety and Efficacy of a Percutaneous Peripheral Nerve Stimulation System in Patients With Peripheral Neuropathic Pain

This trial was conducted in a prospective, multicenter, randomized withdrawal design at a designated clinical trial facility. The total sample size for this trial is expected to be 59-62 patients.

One to two subjects were conducted in each study center as a preliminary test. A total of about 3-6 subjects were selected for the pre-test. The pre-test subjects used the test equipment (on state) and were not randomized.

The study was divided into screening/baseline period, treatment period (including test period, random withdrawal period and observation period) and follow-up period.

All subjects underwent a 7-day baseline assessment (VAS score for at least 4 days) during the screening/baseline period. Eligible subjects underwent Peripheral Nerve Stimulation(PNS) surgery and implanted electrode leads and entered the 7-day test period. During the test period, subjects with an average VAS score improvement of ≥30%(VAS score for at least 4 days) will be randomly assigned to the experimental group (on state) or the control group (off state) in a 1:1 ratio for 7 days observation. All subjects were enrolled in the observation period until 28 days after implantation. Safety assessment was performed at a 14-day follow-up after removal of the device.

Study Overview

• Status: Recruiting
• Conditions: Complications; Prosthesis, Nervous System, Peripheral, Pain
• Intervention / Treatment: Device: Percutaneous peripheral nerve stimulation system

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ke Ma, PhD; Phone Number: 86-21-25078707; Email: marke72@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Recruiting
      • Ke Ma, PhD
      • Contact: Ke Ma, PhD; Phone Number: 86-21-25078707; Email: marke72@163.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age ≥18 years old, gender unlimited;
• The investigator judged that there was definite peripheral neuropathic pain (chronic and refractory pain in the trunk and extremities, including chronic pain after sternal surgery; Postherpetic neuralgia), suitable for percutaneous peripheral nerve stimulation system treatment;
• Preoperative assessment by neuropathic Pain Scale (DN4) showed that there were related damages or diseases in the peripheral sensory system;
• Patients with poor efficacy or can not tolerate the side effects of treatment after routine treatment;
• Visual analogue scale (VAS)≥50mm within 24 hours before treatment;
• The subject can understand the study purpose, demonstrate sufficient compliance with the study protocol, and be able and willing to sign the informed consent.

Exclusion Criteria:

• Patients who need to be treated with radiofrequency regulation and intrathecal drug infusion;
• Patients who are known to have had heart implants (pacemakers or defibrillators) or other implanted neurostimulators (spinal cord stimulators or deep brain stimulators, etc.);
• Patients with severe psychological and/or psychiatric illness and/or non-therapeutic drug dependence;
• Patients who are expected to undergo MRI within 30 days after PNS implantation;
• Expected to be discharged within 48 hours or less;
• There is known damage to the target nerve or muscle defect in the pain area;
• Patients with known allergies to skin-to-skin contact materials (tape or adhesive);
• Known allergy to anesthetics such as lidocaine;
• Preoperative complications of severe heart, liver, kidney, respiratory diseases and coagulopathy;
• Pregnant or lactating women, or have a birth plan in the next 3 months;
• Is participating in any other drug or medical device clinical trial, or may participate in any other drug or medical device clinical trial after enrollment in this clinical trial;
• The investigator determined that there were other conditions that were not suitable to participate in the clinical trial.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Turn on the machine for continuous nerve stimulation	Device: Percutaneous peripheral nerve stimulation system; All subjects underwent a 7-day baseline assessment (VAS score for at least 4 days) during the screening/baseline period. Eligible subjects underwent PNS surgery and implanted electrode leads and entered the 7-day test period. During the test period, subjects with an average VAS score improvement of ≥30%(VAS score for at least 4 days) will be randomly assigned to the experimental group (on state) or the control group (off state) in a 1:1 ratio for 7 days observation. All subjects were enrolled in the observation period until 28 days after implantation. Safety assessment was performed at a 14-day follow-up after removal of the device.
No Intervention: control group; Turn off the machine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference of the mean VAS scores of the experimental group and the control group during the random withdrawal period	(VASEGbase -- VASEGwd) Average - (VASCGbase -- VASCGwd) Average Explanation: VASEGbase was the mean VAS score of subjects in the experimental group at 4 days before the random withdrawal period. VASEGwd was the maximum VAS score of subjects in the experimental group during the random withdrawal period. VASCGbase was the mean VAS score of subjects in the control group at 4 days before the random withdrawal period. The maximum VAS score of subjects in the VASCGwd control group during the random withdrawal period.	7 days after the wire implantation test period

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: November 30, 2022
• First Submitted That Met QC Criteria: April 12, 2023
• First Posted (Actual): April 25, 2023

Study Record Updates

• Last Update Posted (Actual): June 28, 2024
• Last Update Submitted That Met QC Criteria: June 27, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Peripheral nerve pain
• Other Study ID Numbers: XH-22-007

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No