Differential Target Multiplexed Spinal Cord Stimulation (DTM-SCS®) Real World Outcomes
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|ClinicalTrials.gov Identifier: NCT04725838|
Recruitment Status : Recruiting
First Posted : January 27, 2021
Last Update Posted : September 29, 2022
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|Condition or disease||Intervention/treatment|
|Chronic Pain||Device: Medtronic Intellis™ and Vanta™|
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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||600 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 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™ and Vanta™
Differential Target Multiplexed (DTM®) programming using Medtronic's Intellis™ or Vanta™ Spinal Cord Stimulation systems
- 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 ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Participant must provide written informed consent prior to any clinical study-related procedure.
- Participant is at least 18 years (or the minimum age required by local law to consent for participation in a clinical investigation) or older at the time of enrollment.
- Participant has a permanent Medtronic Intellis™ neurostimulation system implanted or is planning to be implanted with a Medtronic Intellis™ or Vanta™ neurostimulation system.
- Participant has access to an iPhone or Android capable device and/or computer with regular internet access for the purposes of electronically completing web-based participant self-reported questionnaires via SMS text or email.
- Participant is unable to provide written informed consent or to comply with study-related requirements, procedures, and visits.
- Participant is a profound responder for all pain areas to existing neurostimulation therapy (≥80% reported relief).
- Participant is enrolled, or intends to participate, in a clinical drug and/or device study (investigational device, investigational drug, new indication for a device or drug, or additional testing beyond standard of care procedures) which could confound the results of this trial as determined by the investigator.
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the participant's ability to participate in the clinical investigation or to comply with follow-up requirements.
- Participant is pregnant or nursing.
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|
|Responsible Party:||Celéri Health, Inc.|
|Other Study ID Numbers:||
|First Posted:||January 27, 2021 Key Record Dates|
|Last Update Posted:||September 29, 2022|
|Last Verified:||September 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|