StimRouter Registry Clinical Protocol

A Prospective, Open-label, Long-term, Multi-center, Registry to Assess the Safety and Efficacy of the Bioness StimRouter Neuromodulation System in Subjects With Chronic Pain of Peripheral Nerve Origin

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.

Study Overview

• Status: Completed
• Conditions: Nervous System Diseases; Chronic Pain; Peripheral Nervous System Diseases; Peripheral Neuropathy; Peripheral Nerve Injuries; Peripheral Nervous System Problem; Peripheral Nervous
• Intervention / Treatment: Device: StimRouter Neuromodulation System

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 Type: Observational
• Enrollment (Actual): 62

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • University Of California San Diego
    • Larkspur, California, United States, 94939
      • California Orthopedics & Spine
    • Redwood City, California, United States, 94063
      • Stanford University
  • Connecticut
    • Stamford, Connecticut, United States, 06905
      • Stamford Hospital
  • District of Columbia
    • Washington, D.C., District of Columbia, United States, 20037
      • International Spine,Pain and Performance Center
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70817
      • Warner Orthopedics
  • Pennsylvania
    • Elkins Park, Pennsylvania, United States, 19027
      • Albert Einstein/Moss Rehab
  • Virginia
    • Blacksburg, Virginia, United States, 24060
      • Valley Sports and Spine Clinic
  • Wisconsin
    • Oshkosh, Wisconsin, United States, 54904
      • Advocate Aurora Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Up to 173 adult subjects (18 years or older) who have chronic pain of peripheral nerve origin, or other causes for which the Clinician determines StimRouter is the appropriate therapy.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
StimRouter Neuromodulation System; Implant of the Bioness StimRouter Neuromodulation System in subjects with chronic pain of peripheral nerve origin	Device: StimRouter Neuromodulation System; An implantable neuromodulation device that treats chronic peripheral nerve pain.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in average pain	Average change from baseline to Month 12 post-implantation measured through a NPRS scale	Month 12
Change in average pain	Average change from baseline to Month 24 post-implantation measured through a NPRS scale	Month 24
Change in Pain Severity	Average change from baseline to Month 12 post-implantation in Pain Severity measured through the BPI-SF	Month 12
Change in Pain Severity	Average change from baseline to Month 24 post-implantation in Pain Severity measured through the BPI-SF	Month 24
Change in Pain Interference	Average change from baseline to Month 12 post-implantation in Pain Interference measured through the BPI-SF	Month 12
Change in Pain Interference	Average change from baseline to Month 24 post-implantation in Pain Interference measured through the BPI-SF	Month 24
Change in Health-related Quality of Life	Average change from baseline to month 12 in health-related quality of life as assess by the VR-12 questionnaire	Month 12
Change in Health-related Quality of Life	Average change from baseline to month 24 in health-related quality of life as assess by the VR-12 questionnaire	Month 24
Change in Patient Global Impression of Change	Average change from baseline to month 12 in patient global impression of change (PGIC)	Month 12
Change in Patient Global Impression of Change	Average change from baseline to month 24 in patient global impression of change (PGIC)	Month 24
Pain Medication Use	Decrease in chronic pain related medication intake at month 12 when compared to baseline	Month 12
Pain Medication Use	Decrease in chronic pain related medication intake at month 24 when compared to baseline	Month 24

Collaborators and Investigators

• Sponsor: Bioness Inc
• Investigators: Study Director: Eric Grigsby, MD, Bioness Inc; Study Chair: Keith McBride, Bioness Inc

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2019
• Primary Completion (Actual): March 30, 2024
• Study Completion (Actual): June 30, 2024

Study Registration Dates

• First Submitted: March 25, 2019
• First Submitted That Met QC Criteria: April 11, 2019
• First Posted (Actual): April 12, 2019

Study Record Updates

• Last Update Posted (Estimated): May 20, 2025
• Last Update Submitted That Met QC Criteria: May 15, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: peripheral nerve stimuation (PNS)
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Neuromuscular Diseases; Trauma, Nervous System; Chronic Pain; Peripheral Nervous System Diseases; Nervous System Diseases; Peripheral Nerve Injuries
• Other Study ID Numbers: CP-00001

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.: Yes