CompaRison of Paresthesia Mapping to anatomIc Midline-based burSt Programming Strategies

Exclusion Criteria

• •Subjects with significant scoliosis even if surgically corrected
• •Subject is currently participating in a clinical investigation that includes an active treatment arm;
• •Subject has been implanted with or participated in a trial period for a neurostimulation system;
• •Subject has an infusion pump;
• •Subject has evidence of an active disruptive psychological or psychiatric disorder as determined as per standard of care;
• •Subject has a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus;
• •Subject has a current diagnosis of a progressive neurological disease as determined by the Investigator;
• •Subject is immunocompromised;
• •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 history of cancer requiring active treatment in the last 12 months;
• •Subject has an existing medical condition that is likely to require the use of diathermy in the future;
• •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).