NAPS: Non-awake Versus Awake Placement of Spinal Cord Stimulators

The primary objective is to demonstrate the safety and efficacy of a non-awake implantation
method (EMG neuromonitoring) of a SCS paddle lead as compared to an awake implantation method
(with local anesthesia and patient feedback).This is a post-market, prospective, multicenter,
parallel designed, non-randomized, non-blinded, 6-month study. A minimum of 50 patients will
be implanted from up to 4 active sites, coordinated by a single lead investigator.

Patients who have had a successful SCS trial and are indicated for permanent implantation
will be approached to participate in this study prior to permanent implantation. Patients
will be recruited and enrolled by physicians at any one of the involved sites. Each
Investigator will only use one method (awake or non-awake) according to his/her typical
practice. Patients will receive treatment from their enrolling physician.