ID: 213534 Early Outcomes With the Medtronic Closed-Loop Spinal Cord Stimulation Study

Abstract

Spinal cord stimulation (SCS) is a therapy for the treatment of chronic pain that relies on the application of mild electrical stimulation delivered to the dorsal column fibers of the spinal cord via lead(s) implanted in the epidural space. Most of the current SCS systems do not adjust the stimulation to reflect changes in distance between the SCS lead and the cord during activities of daily living. Hence, the net energy delivered varies dynamically resulting in inconsistent therapy delivery i.e., open-loop (OL) SCS.1 Closed-Loop SCS (CL SCS), where the therapy is titrated by the physiologic response of the spinal cord to stimulation – known as evoked compound action potential (ECAPs),2 can be used to address this limitation of OL SCS systems. The objective of this study is to evaluate patient experience and therapy durability with CL SCS. Primary study objective is to demonstrate the reduction in overstimulation sensation with the CL feature in subjects implanted with the CL SCS system. Secondary objectives include characterizing therapy efficacy in reducing overall, back or leg pain as measured by the proportion of subjects with ≥50% reduction in pain score, at the time of the 3-month visit. Consistency of dosing and long-term durability of therapy will also be characterized.