SUNBURST (Success Using Neuromodulation With BURST) Study

Success Using Neuromodulation With BURST (SUNBURST™) Study

The purpose of the study is to demonstrate the safety and efficacy of the Prodigy system for the treatment of chronic intractable pain of the trunk and/or limbs.

Inclusion Criteria:

• Subject is 22 years of age or older
• Subject has chronic intractable pain of the trunk and/or limbs
• Subject has a average score of 60 or higher for average daily overall pain on the Visual Analog Scale (VAS) 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 from activation through the 24 week follow-up visit

Exclusion Criteria:

• Subject is currently participating in a clinical investigation that includes an active treatment arm
• Subject has been implanted with a previous neurostimulation system or participated in a trial period for a neurostimulation 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 screening visit
• Subject has an infusion pump or any implantable neurostimulator device
• Subjects with concurrent clinically significant or disabling chronic pain problem that requires additional treatment
• Subject has an existing medical condition that is likely to require repetitive Magnetic Resonance Imaging (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's pain originates from 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 urine/blood pregnancy test)