StimRouter Registry Clinical Protocol

Completed

• Conditions: Peripheral Nervous System Diseases; Peripheral Nerve Injuries; Chronic Pain; Nervous System Diseases; Peripheral Nervous System Problem; Peripheral Neuropathy; Peripheral Nervous
• Interventions: Device: StimRouter Neuromodulation System

• Registration Number: NCT03913689
• Lead Sponsor: Bioness Inc

Brief Summary

This Registry study will prospectively evaluate the long-term effectiveness, safety, and tolerability of the StimRouter Neuromodulation System, along with evaluating the technical performance of StimRouter, surgical outcomes, health-related quality of life, concomitant medical use, and subject's impression of improvement.

Detailed Description

This is a prospective, open-label, long-term, multi-center registry. Up to 173 subjects with chronic pain related to peripheral nerve will be enrolled by approximately 15 qualified sites. Subjects who are eligible for a StimRouter will be enrolled in order to evaluate the subject's experience at pre-implant, the implant, and post-implant for up to 24 months. Based on routine care, subjects will be seen at day of implant, within 2 weeks post-implant, 3 months post-implant, 6 months post-implant, 9 months post implant, 12 months post-implant, and 24 month post-implant.

Study Timeline

• Study First Submitted: 2019-03-25
• Study First Submitted QC: 2019-04-11
• Study First Posted: 2019-04-12
• Study Start: 2019-06-26
• Primary Completion: 2024-03-30
• Study Completion: 2024-06-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

1. Subject is at least 18 years of age at the time of giving informed consent.
2. Subject who has chronic pain of peripheral nerve origin
3. Subject is eligible for StimRouter as determined by the Clinician.
4. Subject has a score of 5 or higher on the Pain NRS for average pain specific to the area(s) of chronic pain being treated over the past 24 hours
5. Subject is planned to be scheduled for implant of StimRouter.
6. Subject has a life expectancy greater than 6 months as determined by the Clinician.
7. Subject who is able to read, understand, and voluntarily sign the IRB-approved informed consent form prior to the performance of any study-specific procedures.
8. Subject who is able to understand and complete required assessments.

Exclusion Criteria

1. Subject has other concomitant treatment or medical condition that, in the opinion of the Clinician, prevents the subject from study participation.
2. Subject who, for implantation in the trunk, has an implanted demand-type cardiac pacemaker or defibrillator.
3. Subject has or plans to have a Spinal Cord Stimulator (SCS), Peripheral Nerve field Stimulation System (PNfS), Dorsal Root Ganglion system (DRG), or implantable infusion pump.
4. Subject who has an implanted device in the area for StimRouter implantation without sponsor approval. Maintain a minimum separation distance of 6 inches (15 cm) between the StimRouter system and all other active implanted devices.
5. Subject who requires, or is likely to require, diathermy at the implant site.
6. Subject who requires, or is likely to require, therapeutic ultrasound at the implant site.
7. Subject who has a cancerous lesion present near the target stimulation point.
8. Subject with a bleeding disorder, which, in the opinion of the investigator, is a contraindication to device placement.
9. Subject who has an active systemic infection.
10. Subject who is immunocompromised and/ or determined by the Clinician to be clinically inappropriate for the procedure and implant.
11. Subject who has an active or existing skin disorder or irritation, which, at the Clinician's discretion, precludes the use of skin gel electrodes.
12. Subject who currently require or is likely to require Magnetic Resonance Imaging (MRI) within the MRI exclusion zone: the entire StimRouter lead must be at least 50 cm from the center of the MRI system's bore (the iso-center) and at least 16 cm outside of the MRI coil measured from the edge of the MRI coil.
13. Subject who has a history of adverse reactions to local anesthetic (e.g., lidocaine).
14. Subject who is pregnant, plan on becoming pregnant, or is breastfeeding during the study period.
15. Subject who is participating in any other study that could affect the outcome of the registry, such as a spinal stimulation study.
16. Subject who is in litigation related to their pain, or who has a pending or active worker's compensation claim. (A patient receiving long-term medical care from a settled Worker-s Compensation claim would not be excluded.)
17. Subject who declines to provide written consent or follow-up.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
StimRouter Neuromodulation System	StimRouter Neuromodulation System	Implant of the Bioness StimRouter Neuromodulation System in subjects with chronic pain of peripheral nerve origin

Primary Outcome Measures

Name	Time	Method
Change in Pain from Screening through 6 Months	Month 6	Change from baseline to 6 months post-permanent implant in aversge pain assessed by using a Numeric Rating Scale

Secondary Outcome Measures

Name	Time	Method
Change in Pain Interference post-implantation	Month 6	Average change from baseline to month 6 post-implantation in Pain Interference score as measured through the BPI-SF
Change in Pain Severity post-implantation	Month 6	Average change from baseline to month 6 post-implantation in Pain Severity score as measured through the BPI-SF
Change in Health-related Quality of Life	MOnth 6	Average change from baseline to month 6 in health-related quality of life as assess by the VR-12 questionnaire
Change in Patient Global Impression of change	Month 6	Average change from baseline to month 6 in patient global impression of change (PGIC)
Patient Treatment Satisfaction	Month 6	Overall patient treatment satisfaction survey
Pain medication use	Month 6	Decrease in chronic pain related medication intake at month 6 when compared to baseline

Trial Locations

Locations (9)

University of California San Diego; 🇺🇸 La Jolla, California, United States

California Orthopedics & Spine; 🇺🇸 Larkspur, California, United States

Stanford University; 🇺🇸 Redwood City, California, United States

Stamford Hospital; 🇺🇸 Stamford, Connecticut, United States

International Spine,Pain and Performance Center; 🇺🇸 Washington, D.C., District of Columbia, United States

Warner Orthopedics; 🇺🇸 Baton Rouge, Louisiana, United States

Advocate Aurora Health; 🇺🇸 Oshkosh, Wisconsin, United States

Albert Einstein/Moss Rehab; 🇺🇸 Elkins Park, Pennsylvania, United States

Valley Sports and Spine Clinic; 🇺🇸 Blacksburg, Virginia, United States