Phase
Condition
Pain (Pediatric)
Neuropathy
Pain
Treatment
Evoke
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 enrollment.
Diagnosed with chronic, intractable pain of the trunk and/or limbs, which has been refractory to conservative therapy for a minimum of 6 months.
Subject has a minimum Visual Analog Scale (VAS) score of 60 mm or higher (where 100 mm indicates the worst imaginable pain) at baseline.
Be an appropriate candidate for the surgical procedures required in this study based on 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, and visits.
Exclusion
Exclusion Criteria:
Subject is pregnant or nursing.
Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, as determined by the Investigator.
Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention, and/or ability to evaluate treatment outcomes.
Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker, deep brain stimulator (DBS), or sacral nerve stimulator (SNS).
Have prior experience with SCS.
Be concomitantly participating in another clinical study.
Study Design
Connect with a study center
The Spine and Nerve Center of Saint Francis Hospital
Charleston, West Virginia 25301
United StatesSite Not Available
The Spine and Nerve Center of Saint Francis Hospital
Charleston 4801859, West Virginia 4826850 25301
United StatesSite Not Available

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