Phase
Condition
Peripheral Neuropathy
Chronic Pain
Pain
Treatment
N/AClinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 thearea(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-approvedinformed consent form prior to the performance of any study-specific procedures.
- Subject who is able to understand and complete required assessments.
Exclusion
Exclusion Criteria:
- Subject has other concomitant treatment or medical condition that, in the opinion ofthe Clinician, prevents the subject from study participation.
- Subject who, for implantation in the trunk, has an implanted demand-type cardiacpacemaker or defibrillator.
- Subject has or plans to have a Spinal Cord Stimulator (SCS), Peripheral Nerve fieldStimulation System (PNfS), Dorsal Root Ganglion system (DRG), or implantable infusionpump.
- Subject who has an implanted device in the area for StimRouter implantation withoutsponsor approval. Maintain a minimum separation distance of 6 inches (15 cm) betweenthe 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 implantsite.
- 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 acontraindication to device placement.
- Subject who has an active systemic infection.
- Subject who is immunocompromised and/ or determined by the Clinician to be clinicallyinappropriate for the procedure and implant.
- Subject who has an active or existing skin disorder or irritation, which, at theClinician'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 fromthe center of the MRI system's bore (the iso-center) and at least 16 cm outside of theMRI 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 thestudy period.
- Subject who is participating in any other study that could affect the outcome of theregistry, such as a spinal stimulation study.
- Subject who is in litigation related to their pain, or who has a pending or activeworker's compensation claim. (A patient receiving long-term medical care from asettled Worker-s Compensation claim would not be excluded.)
- Subject who declines to provide written consent or follow-up.
Study Design
Study Description
Connect with a study center
University of California San Diego
La Jolla, California 92093
United StatesActive - Recruiting
California Orthopedics & Spine
Larkspur, California 94939
United StatesActive - Recruiting
Stanford University
Redwood City, California 94063
United StatesActive - Recruiting
Stamford Hospital
Stamford, Connecticut 06905
United StatesCompleted
International Spine,Pain and Performance Center
Washington, District of Columbia 20037
United StatesActive - Recruiting
Warner Orthopedics
Baton Rouge, Louisiana 70817
United StatesActive - Recruiting
Albert Einstein/Moss Rehab
Elkins Park, Pennsylvania 19027
United StatesActive - Recruiting
Valley Sports and Spine Clinic
Blacksburg, Virginia 24060
United StatesActive - Recruiting
Advocate Aurora Health
Oshkosh, Wisconsin 54904
United StatesActive - Recruiting
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