Local Cerebral Oxygenation in Chronic Pain Patients Utilizing Spinal Cord Stimulation

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 been refractory to conservative therapy for a minimum of 6 months
• Subject has a minimum Visual Analog Scale (VAS) score of 50 mm or higher (where 100 mm indicates the worst imaginable pain) at baseline or a 5 on a Numerical Rating Scale (NRS)
• 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 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
• Subject has secondary gain issues that could interfere with the study measures or outcomes
• 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 on the forehead, or ENT surgery)
• Subject is allergic to any adhesives, materials or fluids in or used in conjunction with the CereVu sensor