Phase
Condition
Chronic Pain
Pain
Treatment
CereVu Device
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Be 18 years of age or older at the time of enrolment
Diagnosed with chronic, intractable pain of the trunk and/or limbs, which has beenrefractory to conservative therapy for a minimum of 6 months
Subject has a minimum Visual Analog Scale (VAS) score of 50 mm or higher (where 100mm indicates the worst imaginable pain) at baseline or a 5 on a Numerical RatingScale (NRS)
Be an appropriate candidate for the surgical procedures required in this study basedon the clinical judgment of the implanting physician
Be willing and capable of giving informed consent
Be willing and able to comply with study-related requirements, procedures, andvisits
Exclusion
Exclusion Criteria:
Subject is pregnant or nursing
Have a medical condition or pain in other area(s), not intended to be treated withSCS, that could interfere with study procedures, as determined by the Investigator
Have evidence of an active disruptive psychological or psychiatric disorder or otherknown condition significant enough to impact perception of pain, compliance ofintervention, and/or ability to evaluate treatment outcomes
Have an existing drug pump and/or SCS system or another active implantable devicesuch as a pacemaker, deep brain stimulator (DBS), or sacral nerve stimulator (SNS)
Have prior experience with SCS
Be concomitantly participating in another clinical study
Subject has secondary gain issues that could interfere with the study measures oroutcomes
Subject is contraindicated for use of non-invasive cerebral oxygenation measurements (e.g., at risk for sensor displacement such as facial cosmetic. Non-intact skin onthe forehead, or ENT surgery)
Subject is allergic to any adhesives, materials or fluids in or used in conjunctionwith the CereVu sensor
Study Design
Connect with a study center
Boomerang Healthcare
Walnut Creek, California 94598
United StatesActive - Recruiting
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