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

Chronic Pain Clinical Trial

Official title:
The UPGRADE Study: Real World Outcomes® of Differential Target Multiplexed (DTM-SCS®) Stimulation in Existing and New Medtronic Implants

Clinical Trial Summary

The UPGRADE registry will capture long-term, real-world outcomes to understand the effect of Differential Target Multiplexed (DTM®) programming in the Spinal Cord Stimulation (SCS) implanted population on the management of chronic pain, primarily on its use for trunk and/or limb pain. The clinical study is sponsored by Celéri Health and is funded through a financial grant from Medtronic's External Research Program. The registry study will be conducted across approximately 25 centers in the United States with up to 600 participants enrolled.

Clinical Trial 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™ and Vanta™ spinal cord stimulators, 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 a follow-up period for up to 24 months, where participant self-reported questionnaires will be assessed each month with study visits to occur at months 12 and 24. Throughout the study, objective functional data will be collected automatically as part of the Medtronic device interrogation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04725838
Study type Observational [Patient Registry]
Source Celéri Health, Inc.
Contact Jean Myers
Phone 215-828-9070
Email jean@celerihealth.com
Status Recruiting
Phase
Start date January 29, 2021
Completion date January 29, 2025
View Details
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