Clinical trial NCT03913689: StimRouter Registry Clinical Protocol
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Peripheral Neuropathy
Nervous System Diseases
Peripheral Nervous System Diseases
Peripheral Nervous System Problem
Peripheral Nerve Injuries
Peripheral Nervous
Keywords: peripheral nerve stimuation (PNS)
Lead sponsor: Bioness Inc
Sponsor class: INDUSTRY
First posted: 2019-04-12
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Pain from Screening through 6 Months
timeFrame: Month 6
Secondary outcomes:
measure: Change in Pain Severity post-implantation
timeFrame: Month 6
measure: Change in Pain Interference post-implantation
timeFrame: Month 6
measure: Change in Health-related Quality of Life
timeFrame: MOnth 6
measure: Change in Patient Global Impression of change
timeFrame: Month 6
measure: Patient Treatment Satisfaction
timeFrame: Month 6
measure: Pain medication use
timeFrame: Month 6
Other outcomes:
measure: Change in average pain
timeFrame: Month 12
measure: Change in average pain
timeFrame: Month 24
measure: Change in Pain Severity
timeFrame: Month 12
measure: Change in Pain Severity
timeFrame: Month 24
measure: Change in Pain Interference
timeFrame: Month 12
measure: Change in Pain Interference
timeFrame: Month 24
measure: Change in Health-related Quality of Life
timeFrame: Month 12
measure: Change in Health-related Quality of Life
timeFrame: Month 24
measure: Change in Patient Global Impression of Change
timeFrame: Month 12
measure: Change in Patient Global Impression of Change
timeFrame: Month 24
measure: Pain Medication Use
timeFrame: Month 12
measure: Pain Medication Use
timeFrame: Month 24
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Larkspur
country: United States
facility: California Orthopedics & Spine
state: California
city: Redwood City
country: United States
facility: Stanford University
state: California
city: Stamford
country: United States
facility: Stamford Hospital
state: Connecticut
city: Washington, D.C.
country: United States
facility: International Spine,Pain and Performance Center
state: District of Columbia
city: Baton Rouge
country: United States
facility: Warner Orthopedics
state: Louisiana
city: Elkins Park
country: United States
facility: Albert Einstein/Moss Rehab
state: Pennsylvania
city: Blacksburg
country: United States
facility: Valley Sports and Spine Clinic
state: Virginia
city: Oshkosh
country: United States
facility: Advocate Aurora Health
state: Wisconsin
Study officials:
affiliation: Bioness Inc
name: Keith McBride
role: STUDY_CHAIR
affiliation: Bioness Inc
name: Eric Grigsby, MD
role: STUDY_DIRECTOR
References: