Differential Target Multiplexed Spinal Cord Stimulation (DTM-SCS®) Real World Outcomes

Summary

Participation Requirements

Description

This clinical investigation is a prospective, observational, open-label, non-randomized, multi-center study. It is designed to collect clinical follow-up data on Differential Target Multiplexed (DTM®) programming that is available in Medtronic's Intellis™ spinal cord stimulator, which has shown supe...

This clinical investigation is a prospective, observational, open-label, non-randomized, multi-center study. It is designed to collect clinical follow-up data on Differential Target Multiplexed (DTM®) programming that is available in Medtronic's Intellis™ spinal cord stimulator, which has shown superiority to conventional programming parameters in a randomized controlled trial (NCT03606187). Participants currently implanted with a permanent neurostimulation system, whom are planned for conversion to DTM® programming as well as newly identified participants planned to undergo a trial of neurostimulation using DTM® will be eligible to participate in this study. Data will be collected at baseline prior to DTM® programming exposure. Participants who continue to meet eligibility criteria and have had their implanted DTM programming activated will enter the 24-month follow-up period, where participant self-reported questionnaires will be assessed each month with study visits to occur at months 3, 6, 12 and 24. Throughout the study, objective functional data will be collected automatically as part of the Medtronic Intellis™ device interrogation.

Tracking Information