StimRouter Registry Clinical Protocol

An observational study of Chronic Pain and Peripheral Neuropathy, run by Bioness Inc at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Chronic Pain, Peripheral Neuropathy, Nervous System Diseases
What is being tested?: StimRouter Neuromodulation System
Type of treatment: Medical device
How many people: 62 participants
Where: 9 sitesUnited States
Study dates: 26 Jun 2019to 30 Jun 2024
How long will I take part?: 6 Months
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

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.

Who may be able to join

Subject is at least 18 years of age at the time of giving informed consent.
Subject who has chronic pain of peripheral nerve origin
Subject is eligible for StimRouter as determined by the Clinician.
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
Subject is planned to be scheduled for implant of StimRouter.
Subject has a life expectancy greater than 6 months as determined by the Clinician.
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.
Subject who is able to understand and complete required assessments.

Who cannot join

Subject has other concomitant treatment or medical condition that, in the opinion of the Clinician, prevents the subject from study participation.
Subject who, for implantation in the trunk, has an implanted demand-type cardiac pacemaker or defibrillator.
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.
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.
Subject who requires, or is likely to require, diathermy at the implant site.
Subject who requires, or is likely to require, therapeutic ultrasound at the implant site.

Show all 17Show fewer

Subject who has a cancerous lesion present near the target stimulation point.
Subject with a bleeding disorder, which, in the opinion of the investigator, is a contraindication to device placement.
Subject who has an active systemic infection.
Subject who is immunocompromised and/ or determined by the Clinician to be clinically inappropriate for the procedure and implant.
Subject who has an active or existing skin disorder or irritation, which, at the Clinician's discretion, precludes the use of skin gel electrodes.
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.
Subject who has a history of adverse reactions to local anesthetic (e.g., lidocaine).
Subject who is pregnant, plan on becoming pregnant, or is breastfeeding during the study period.
Subject who is participating in any other study that could affect the outcome of the registry, such as a spinal stimulation study.
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.)
Subject who declines to provide written consent or follow-up.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

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

Other trials in United States

About this study

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

Read the 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.

Conditions: Chronic Pain, Peripheral Neuropathy, Nervous System Diseases, Peripheral Nervous System Diseases, Peripheral Nervous System Problem, Peripheral Nerve Injuries
Being tested: StimRouter Neuromodulation System
Keywords: peripheral nerve stimuation (PNS)
Medical subject headings: Chronic Pain, Peripheral Nervous System Diseases, Nervous System Diseases, Peripheral Nerve Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

StimRouter Neuromodulation SystemDevice
An implantable neuromodulation device that treats chronic peripheral nerve pain.

Study groups in NCT03913689
Study group	Role	What they receive
StimRouter Neuromodulation System		Implant of the Bioness StimRouter Neuromodulation System in subjects with chronic pain of peripheral nerve origin Receives: Device: StimRouter Neuromodulation System

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Month 6

Secondary outcomes (6)

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
Measured: 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
Measured: 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
Measured: MOnth 6
Change in Patient Global Impression of change
Average change from baseline to month 6 in patient global impression of change (PGIC)
Measured: Month 6
Patient Treatment Satisfaction
Overall patient treatment satisfaction survey
Measured: Month 6
Pain medication use
Decrease in chronic pain related medication intake at month 6 when compared to baseline
Measured: Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Jun 201930 Jun 2024

First posted12 Apr 2019
Study start26 Jun 2019
Primary completion30 Mar 2024
Study completion30 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 62 participants (actual)
Target duration: 6 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT03913689
Sponsor's protocol ID: CP-00001
Status last verified: May 2025
First submitted: 25 Mar 2019
Last updated: 20 May 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Efficacy of a Chronic Pain Treatment Prior to Gender-affirming Surgery
Pain Catastrophizing, Pain, Chronic
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
Recruiting
Uncovering the Mechanism of Pain Relief by Peripheral Transcutaneous Magnetic Stimulation
Post-Surgical Pain, Chronic, Post-traumatic Pain, Chronic
Recruiting
Daily Knee Sleeve Use Versus No Use in Older Adults With Chronic Knee Pain
Knee Arthritis, Osteoarthritis

All Chronic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03913689
Acronym / sponsor ID: CP-00001
Conditions: Chronic Pain, Peripheral Neuropathy, Nervous System Diseases, Peripheral Nervous System Diseases, Peripheral Nervous System Problem, Peripheral Nerve Injuries
Keywords: peripheral nerve stimuation (PNS)
Study type: Observational
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: Bioness IncIndustry (pharma, biotech, devices)
Study start: 26 Jun 2019 (actual)
Primary completion: 30 Mar 2024 (actual)
Study completion: 30 Jun 2024 (actual)
First posted: 12 Apr 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective
Target follow-up: 6 Months
Number of arms: 1

Arm	Type	Receives
StimRouter Neuromodulation System	–	Device: StimRouter Neuromodulation SystemImplant of the Bioness StimRouter Neuromodulation System in subjects with chronic pain of peripheral nerve origin

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (8 listed)

Subject is at least 18 years of age at the time of giving informed consent.
Subject who has chronic pain of peripheral nerve origin
Subject is eligible for StimRouter as determined by the Clinician.
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
Subject is planned to be scheduled for implant of StimRouter.

Key exclusion criteria (17 listed)

Subject has other concomitant treatment or medical condition that, in the opinion of the Clinician, prevents the subject from study participation.
Subject who, for implantation in the trunk, has an implanted demand-type cardiac pacemaker or defibrillator.
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.
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.
Subject who requires, or is likely to require, diathermy at the implant site.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
StimRouter Neuromodulation SystemAn implantable neuromodulation device that treats chronic peripheral nerve pain.	Device	StimRouter Neuromodulation System

Primary outcome

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

6 secondary outcomes

Change in Pain Severity post-implantation
Time frame: Month 6
Change in Pain Interference post-implantation
Time frame: Month 6
Change in Health-related Quality of Life
Time frame: MOnth 6
Change in Patient Global Impression of change
Time frame: Month 6
Patient Treatment Satisfaction
Time frame: Month 6
Pain medication use
Time frame: Month 6

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
Individual participant dataSharing planned: No

Related trials for Chronic Pain

Enrolling by invitation
Efficacy of a Chronic Pain Treatment Prior to Gender-affirming Surgery
Pain Catastrophizing, Pain, Chronic
Not yet recruiting
Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
Chronic Pain, Musculoskeletal Pain
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
Recruiting
Uncovering the Mechanism of Pain Relief by Peripheral Transcutaneous Magnetic Stimulation
Post-Surgical Pain, Chronic, Post-traumatic Pain, Chronic
Recruiting
Daily Knee Sleeve Use Versus No Use in Older Adults With Chronic Knee Pain
Knee Arthritis, Osteoarthritis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Keith McBride study chair

Bioness Inc

Eric Grigsby, MD study director

Bioness Inc

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Pain and Peripheral Neuropathy, run by Bioness Inc at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pain from Screening through 6 Months (time frame: Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03913689.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.