SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation) Study

SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation)Study for the Treatment of Chronic Low Back and Leg Pain

The purpose of the study is to demonstrate safety and efficacy of spinal cord stimulation with peripheral nerve field stimulation for the treatment of chronic low back and leg pain.

Key Inclusion Criteria:

• Subject is 22 years of age or older
• Subject has chronic low back and leg pain secondary to Failed Back Surgery Syndrome (FBSS)
• Subject has an average score of 6 or higher for average daily overall pain on the Numerical Rating Scale (NRS) based on the 7 day pain diary
• Subject has attempted "best" medical therapy and has tried and failed at least three documented medically supervised treatments (including, but not limited to physical therapy, acupuncture, etc.) and has failed medication treatment from at least two different classes
• Subject's pain-related medication regimen is stable 4 weeks prior to the baseline evaluation
• Subject agrees not to add or increase pain-related medication throughout the 12 week randomized evaluation phase of the study (starting at activation)

Key Exclusion Criteria:

• Subject currently participating in a clinical investigation that includes an active treatment arm
• Subject has been implanted with a previous neuromodulation system (PNfS, SCS-PNfS or SCS) or participated in a trial for a neuromodulation system
• Subject's overall Beck Depression Inventory II Score is > 24 or has a score of 3 on question 9 relating to suicidal thoughts or wishes at the baseline visit
• Subject with an infusion pump or any implantable neurostimulator device
• Subject has an existing medical condition that is likely to require repetitive MRI evaluation in the future (i.e. epilepsy, stroke, multiple sclerosis, acoustic neuroma, tumor)
• Subject has an existing medical condition that is likely to require the use of diathermy in the future
• Subject has peripheral vascular disease
• Subject is immunocompromised
• Subject has documented history of allergic response to titanium or silicone
• Subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection
• Female candidates of child bearing potential that are pregnant (confirmed by positive pregnancy test)