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

Last updated: August 20, 2024
Sponsor: Celéri Health, Inc.
Overall Status: Completed

Phase

N/A

Condition

Chronic Pain

Pain

Treatment

Medtronic Intellis™ and Vanta™

Clinical Study ID

NCT04725838
UPGRADE
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participant must provide written informed consent prior to any clinicalstudy-related procedure.

  2. Participant is at least 18 years (or the minimum age required by local law toconsent for participation in a clinical investigation) or older at the time ofenrollment.

  3. Participant has a permanent Medtronic Intellis™ neurostimulation system implanted oris planning to be implanted with a Medtronic Intellis™ or Vanta™ neurostimulationsystem.

  4. Participant has access to an iPhone or Android capable device and/or computer withregular internet access for the purposes of electronically completing web-basedparticipant self-reported questionnaires via SMS text or email.

Exclusion

Exclusion Criteria:

  1. Participant is unable to provide written informed consent or to comply withstudy-related requirements, procedures, and visits.

  2. Participant is a profound responder for all pain areas to existing neurostimulationtherapy (≥80% reported relief).

  3. Participant is enrolled, or intends to participate, in a clinical drug and/or devicestudy (investigational device, investigational drug, new indication for a device ordrug, or additional testing beyond standard of care procedures) which could confoundthe results of this trial as determined by the investigator.

  4. Presence of other anatomic or comorbid conditions, or other medical, social, orpsychological conditions that, in the investigator's opinion, could limit theparticipant's ability to participate in the clinical investigation or to comply withfollow-up requirements.

  5. Participant is pregnant or nursing.

Study Design

Total Participants: 255
Treatment Group(s): 1
Primary Treatment: Medtronic Intellis™ and Vanta™
Phase:
Study Start date:
January 29, 2021
Estimated Completion Date:
July 01, 2023

Study 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.

Connect with a study center

  • Neuroversion

    Anchorage, Alaska 99508
    United States

    Site Not Available

  • Desert Sky Spine & Sports Medicine

    Oro Valley, Arizona 85755
    United States

    Site Not Available

  • Desert Sky Spine & Sports Medicine

    Sierra Vista, Arizona 85635
    United States

    Site Not Available

  • NuVation Pain Group - Buena Park

    Buena Park, California 90621
    United States

    Site Not Available

  • NuVation Pain Group - Los Angeles

    Los Angeles, California 90020
    United States

    Site Not Available

  • Spine and Sports Specialty Medical Group

    Orange, California 92801
    United States

    Site Not Available

  • Spine & Nerve Diagnostic Center - Roseville

    Roseville, California 95661
    United States

    Site Not Available

  • Summit Pain Alliance

    Santa Rosa, California 95401
    United States

    Site Not Available

  • Florida Pain Medicine - Brandon

    Brandon, Florida 33511
    United States

    Site Not Available

  • Jax Spine & Pain Centers - Fleming Island

    Fleming Island, Florida 32003
    United States

    Site Not Available

  • Jax Spine & Pain Centers - Jacksonville

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Jax Spine & Pain Centers - UF North

    Jacksonville, Florida 32218
    United States

    Site Not Available

  • Florida Spine & Pain Specialists

    Riverview, Florida 33569
    United States

    Site Not Available

  • Jax Spine & Pain Centers -St. Augustine

    Saint Augustine, Florida 32080
    United States

    Site Not Available

  • Florida Pain Medicine - Wesley Chapel

    Wesley Chapel, Florida 33544
    United States

    Site Not Available

  • National Spine and Pain Centers - Winter Park, FL

    Winter Park, Florida 32789
    United States

    Site Not Available

  • Centurion Spine & Pain Centers (Jax Spine)

    Waycross, Georgia 31501
    United States

    Site Not Available

  • Millennium Pain Center (National Spine and Pain Centers - Bloomington, IL)

    Bloomington, Illinois 61704
    United States

    Site Not Available

  • National Spine and Pain Centers - National Harbor (Oxon Hill)

    Oxon Hill, Maryland 20745
    United States

    Site Not Available

  • National Spine and Pain Centers - Pikesville, MD

    Pikesville, Maryland 21208
    United States

    Site Not Available

  • Comprehensive and Interventional Pain Management

    Henderson, Nevada 89052
    United States

    Site Not Available

  • National Spine and Pain Centers - The Pain Management Center - Voorhees

    Voorhees, New Jersey 08043
    United States

    Site Not Available

  • Carolinas Research Institute - Mallard Creek

    Charlotte, North Carolina 28262
    United States

    Site Not Available

  • Carolinas Research Institute - Huntersville

    Huntersville, North Carolina 28078
    United States

    Site Not Available

  • Premier Pain Treatment Institute - Hillsboro

    Hillsboro, Ohio 45133
    United States

    Site Not Available

  • Premier Pain Treatment Institute - Loveland

    Loveland, Ohio 45140
    United States

    Site Not Available

  • Premier Pain Treatment Institute - Mt. Orab

    Mount Orab, Ohio 45154
    United States

    Site Not Available

  • Oklahoma Pain Physicians - Norman

    Norman, Oklahoma 73072
    United States

    Site Not Available

  • Oklahoma Pain Physicians - Oklahoma City

    Oklahoma City, Oklahoma 73120
    United States

    Site Not Available

  • Oklahoma Pain Physicians - Purcell

    Purcell, Oklahoma 73080
    United States

    Site Not Available

  • North Texas Orthopedics & Spine Center- Keller/Alliance

    Fort Worth, Texas 76244
    United States

    Site Not Available

  • North Texas Orthopedics & Spine Center - Grapevine

    Grapevine, Texas 76051
    United States

    Site Not Available

  • Precision Spine Care

    Tyler, Texas 75701
    United States

    Site Not Available

  • Valley Pain Consultants

    Winchester, Virginia 22601
    United States

    Site Not Available

  • Northwest Pain Care

    Spokane, Washington 99201
    United States

    Site Not Available

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