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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 : September 29, 2022
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Celéri Health, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment
Chronic Pain Device: Medtronic Intellis™ and Vanta™

Detailed 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
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 600 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Groups and Cohorts
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Intervention Details:
  • Device: Medtronic Intellis™ and Vanta™
    Differential Target Multiplexed (DTM®) programming using Medtronic's Intellis™ or Vanta™ Spinal Cord Stimulation systems

Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. To evaluate the longitudinal characterization of objective posture and activity measures. [ Time Frame: 24 months ]
    Time spent in each activity/position (Intellis™ device data)

  4. To characterize Patient Global Impression of Change (PGIC) with neurostimulation. [ Time Frame: 24 months ]
  5. To evaluate the performance of the DTM® pre-programming questionnaire in predicting outcome of DTM-SCS® programming. [ Time Frame: 24 months ]
  6. To characterize the neuropathic pain quality using PROMIS-Neuropathic Pain Quality (PROMIS-PQ-Neuro) before and after treatment. [ Time Frame: 24 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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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
Study Population
Participant has a permanent Medtronic Intellis™ neurostimulation system implanted or is planning to be implanted with a Medtronic Intellis™ or Vanta™ neurostimulation system and is a candidate for Differential Target Multiplexed (DTM®) programming for the management of chronic pain, primarily on its use for trunk and/or limb pain.
Criteria

Inclusion Criteria:

  1. Participant must provide written informed consent prior to any clinical study-related procedure.
  2. 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.
  3. Participant has a permanent Medtronic Intellis™ neurostimulation system implanted or is planning to be implanted with a Medtronic Intellis™ or Vanta™ neurostimulation system.
  4. 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.

Exclusion Criteria:

  1. Participant is unable to provide written informed consent or to comply with study-related requirements, procedures, and visits.
  2. Participant is a profound responder for all pain areas to existing neurostimulation therapy (≥80% reported relief).
  3. 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.
  4. 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.
  5. Participant is pregnant or nursing.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Jean Myers 215-828-9070 jean@celerihealth.com

Locations
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Sponsors and Collaborators
Celéri Health, Inc.
Medtronic
Investigators
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Study Director: Michael Fishman, MD Chief Medical Officer
More Information
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Additional Information:

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Responsible Party: Celéri Health, Inc.
ClinicalTrials.gov Identifier: NCT04725838    
Other Study ID Numbers: UPGRADE
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations