Differential Target Multiplexed Spinal Cord Stimulation (DTM-SCS®) Real World Outcomes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04725838|
Recruitment Status : Recruiting
First Posted : January 27, 2021
Last Update Posted : July 16, 2021
|Condition or disease||Intervention/treatment|
|Chronic Pain||Device: Medtronic Intellis™|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1700 participants|
|Target Follow-Up Duration:||24 Months|
|Official Title:||The UPGRADE Study: Real World Outcomes® of Differential Target Multiplexed (DTM-SCS®) Stimulation in Existing and New Medtronic Intellis™ Implants|
|Actual Study Start Date :||January 29, 2021|
|Estimated Primary Completion Date :||January 29, 2025|
|Estimated Study Completion Date :||January 29, 2025|
- Device: Medtronic Intellis™
Differential Target Multiplexed (DTM®) programming using Medtronic Intellis™ Spinal Cord Stimulation system
- To evaluate the Pain Impact Score as measured by the PROMIS-29 before and after introduction of Differential Target Multiplexed (DTM®) stimulation programming in a real-world population. [ Time Frame: 24 months ]
- To characterize the responder rate for pain by pain area per Percent Pain Relief for DTM-SCS® compared to participant baseline treatment. [ Time Frame: 24 months ]
- To characterize the responder rate for pain by pain area per Numeric Rating Scale for DTM-SCS® compared to participant baseline treatment. [ Time Frame: 24 months ]
- To evaluate the longitudinal characterization of objective posture and activity measures. [ Time Frame: 24 months ]Time spent in each activity/position (Intellis™ device data)
- To characterize Patient Global Impression of Change (PGIC) with neurostimulation. [ Time Frame: 24 months ]
- To evaluate the performance of the DTM® pre-programming questionnaire in predicting outcome of DTM-SCS® programming. [ Time Frame: 24 months ]
- To characterize the neuropathic pain quality using PROMIS-Neuropathic Pain Quality (PROMIS-PQ-Neuro) before and after treatment. [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04725838
|Contact: Jean Myersfirstname.lastname@example.org|
|Study Director:||Michael Fishman, MD||Chief Medical Officer|