Phase
Condition
Chronic Pain
Pain
Peripheral Neuropathy
Treatment
StimRouter Neuromodulation System
Clinical 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 implantableinfusion pump.
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 beclinically inappropriate 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 50cm from the center of the MRI system's bore (the iso-center) and at least 16 cmoutside 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 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 StatesSite Not Available
California Orthopedics & Spine
Larkspur, California 94939
United StatesSite Not Available
Stanford University
Redwood City, California 94063
United StatesSite Not Available
Stamford Hospital
Stamford, Connecticut 06905
United StatesSite Not Available
International Spine,Pain and Performance Center
Washington, District of Columbia 20037
United StatesSite Not Available
International Spine,Pain and Performance Center
Washington, D.C., District of Columbia 20037
United StatesSite Not Available
Warner Orthopedics
Baton Rouge, Louisiana 70817
United StatesSite Not Available
Albert Einstein/Moss Rehab
Elkins Park, Pennsylvania 19027
United StatesSite Not Available
Valley Sports and Spine Clinic
Blacksburg, Virginia 24060
United StatesSite Not Available
Advocate Aurora Health
Oshkosh, Wisconsin 54904
United StatesSite Not Available

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