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

September 28, 2022 updated by: Celéri Health, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Recruiting
        • Neuroversion
        • Contact:
          • Deborah Duricka, PhD
          • Phone Number: 907-339-4655
        • Principal Investigator:
          • Luke Liu, MD
    • Arizona
      • Oro Valley, Arizona, United States, 85755
        • Recruiting
        • Desert Sky Spine & Sports Medicine
        • Contact:
          • Jennifer Shelton
          • Phone Number: 520-229-2080
        • Principal Investigator:
          • Thomas Coury, DO
      • Sierra Vista, Arizona, United States, 85635
        • Recruiting
        • Desert Sky Spine & Sports Medicine
        • Contact:
          • Jennifer Shelton
          • Phone Number: 520-229-2080
        • Principal Investigator:
          • Thomas Coury, DO
    • California
      • Buena Park, California, United States, 90621
        • Recruiting
        • NuVation Pain Group - Buena Park
        • Contact:
          • Kevin Hong
        • Principal Investigator:
          • Phillip Lim, DO
      • Los Angeles, California, United States, 90020
        • Recruiting
        • NuVation Pain Group - Los Angeles
        • Contact:
          • Kevin Hong
        • Principal Investigator:
          • Phillip Lim, DO
      • Orange, California, United States, 92801
        • Recruiting
        • Spine and Sports Specialty Medical Group
        • Contact:
          • Marina Min
          • Phone Number: 714-332-5510
        • Principal Investigator:
          • Eric Chang, MD
      • Roseville, California, United States, 95661
        • Recruiting
        • Spine & Nerve Diagnostic Center - Roseville
        • Contact:
          • Hailey Hunt
        • Principal Investigator:
          • Brian Joves, MD
    • Florida
      • Brandon, Florida, United States, 33511
        • Recruiting
        • Florida Pain Medicine - Brandon
        • Contact:
          • Erin Walsh
          • Phone Number: 813-388-2948
        • Principal Investigator:
          • Maulik Bhalani, MD
      • Fleming Island, Florida, United States, 32003
        • Recruiting
        • Jax Spine & Pain Centers - Fleming Island
        • Contact:
          • Mitchell Urmann
        • Contact:
          • Phone Number: 904-223-3321
        • Sub-Investigator:
          • Aravind Reddy, MD
      • Jacksonville, Florida, United States, 32218
        • Recruiting
        • Jax Spine & Pain Centers - UF North
        • Contact:
          • Mitchell Urmann
        • Contact:
          • Phone Number: 904-223-3321
        • Sub-Investigator:
          • Justin Mann, MD
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • Jax Spine & Pain Centers - Jacksonville
        • Contact:
          • Mitchell Urmann
          • Phone Number: 904-223-3321
        • Sub-Investigator:
          • Christopher Roberts, MD
      • Riverview, Florida, United States, 33569
        • Recruiting
        • Florida Spine & Pain Specialists
        • Contact:
          • Adeline Botello
          • Phone Number: 813-333-1353
        • Principal Investigator:
          • Nomen Azeem, MD
      • Saint Augustine, Florida, United States, 32080
        • Recruiting
        • Jax Spine & Pain Centers -St. Augustine
        • Contact:
          • Mitchell Urmann
          • Phone Number: 904-223-3321
        • Principal Investigator:
          • Michael Hanes, MD
      • Wesley Chapel, Florida, United States, 33544
        • Recruiting
        • Florida Pain Medicine - Wesley Chapel
        • Contact:
          • Erin Walsh
          • Phone Number: 813-388-2984
      • Winter Park, Florida, United States, 32789
        • Recruiting
        • National Spine and Pain Centers - Winter Park, FL
        • Contact:
          • Catherine Rodriguez
          • Phone Number: 407-622-5766
        • Sub-Investigator:
          • Cherian Sajan, MD
    • Georgia
      • Waycross, Georgia, United States, 31501
        • Recruiting
        • Centurion Spine & Pain Centers (Jax Spine)
        • Contact:
          • Mitchell Urmann
          • Phone Number: 912-590-0973
        • Sub-Investigator:
          • Emmanuel Gage, MD
    • Illinois
      • Bloomington, Illinois, United States, 61704
        • Recruiting
        • Millennium Pain Center (National Spine and Pain Centers - Bloomington, IL)
        • Contact:
          • Stephanie Wolf
          • Phone Number: 631-517-8322
        • Sub-Investigator:
          • Eliezer Soto, MD
    • Maryland
      • Oxon Hill, Maryland, United States, 20745
        • Recruiting
        • National Spine and Pain Centers - National Harbor (Oxon Hill)
        • Contact:
          • Diamond Wilson
          • Phone Number: 301-485-7400
        • Principal Investigator:
          • Vipul Mangal, MD
      • Pikesville, Maryland, United States, 21208
        • Recruiting
        • National Spine and Pain Centers - Pikesville, MD
        • Contact:
          • Marvin Bechtold
          • Phone Number: 410-383-7443
        • Sub-Investigator:
          • Mark Coleman, MD
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Recruiting
        • Comprehensive and Interventional Pain Management
        • Contact:
          • Svetla Adintori
          • Phone Number: 702-990-4530
        • Principal Investigator:
          • Rainer Vogel, MD
    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • Recruiting
        • National Spine and Pain Centers - The Pain Management Center - Voorhees
        • Contact:
          • Onoshoze Bossey
          • Phone Number: 856-566-8600
        • Sub-Investigator:
          • Youssef Josephson, DO
    • North Carolina
      • Charlotte, North Carolina, United States, 28262
        • Recruiting
        • Carolinas Research Institute - Mallard Creek
        • Contact:
          • Alex Stevens
          • Phone Number: 704-500-2332
      • Huntersville, North Carolina, United States, 28078
        • Recruiting
        • Carolinas Research Institute - Huntersville
        • Contact:
          • Alex Stevens
        • Contact:
          • Phone Number: 704-500-2332
    • Ohio
      • Hillsboro, Ohio, United States, 45133
        • Recruiting
        • Premier Pain Treatment Institute - Hillsboro
        • Contact:
          • Kathy White
          • Phone Number: 513-454-7246
        • Principal Investigator:
          • Michael Danko, MD
      • Loveland, Ohio, United States, 45140
        • Recruiting
        • Premier Pain Treatment Institute - Loveland
        • Contact:
          • Kathy White
          • Phone Number: 513-454-7246
        • Principal Investigator:
          • Michael Danko, MD
      • Mount Orab, Ohio, United States, 45154
        • Recruiting
        • Premier Pain Treatment Institute - Mt. Orab
        • Contact:
          • Kathy White
          • Phone Number: 513-454-7246
        • Principal Investigator:
          • Michael Danko, MD
    • Oklahoma
      • Norman, Oklahoma, United States, 73072
        • Recruiting
        • Oklahoma Pain Physicians - Norman
        • Contact:
          • Jazzmond Piro
          • Phone Number: 405-463-3380
        • Sub-Investigator:
          • Alina Justiz, MD
      • Oklahoma City, Oklahoma, United States, 73120
        • Recruiting
        • Oklahoma Pain Physicians - Oklahoma City
        • Contact:
          • Jazzmond Piro
          • Phone Number: 405-463-3380
        • Principal Investigator:
          • Rafael Justiz, MD
      • Purcell, Oklahoma, United States, 73080
        • Recruiting
        • Oklahoma Pain Physicians - Purcell
        • Contact:
          • Jazzmond Piro
          • Phone Number: 405-463-3380
        • Sub-Investigator:
          • Alina Justiz, MD
    • Texas
      • Fort Worth, Texas, United States, 76244
        • Recruiting
        • North Texas Orthopedics & Spine Center- Keller/Alliance
        • Contact:
          • Melissa Murphy, MD, MPH
          • Phone Number: 817-481-2121
        • Principal Investigator:
          • Melissa Murphy, MD, MPH
      • Grapevine, Texas, United States, 76051
        • Recruiting
        • North Texas Orthopedics & Spine Center - Grapevine
        • Contact:
          • Melissa Murphy, MD, MPH
          • Phone Number: 817-481-2121
        • Principal Investigator:
          • Melissa Murphy, MD, MPH
      • Tyler, Texas, United States, 75701
        • Recruiting
        • Precision Spine Care
        • Contact:
          • Jeanetta Patterson
          • Phone Number: 903-592-6000
        • Principal Investigator:
          • Aaron Calodney, MD
    • Virginia
      • Winchester, Virginia, United States, 22601
        • Recruiting
        • Valley Pain Consultants
        • Contact:
          • Bekah Smith
          • Phone Number: 540-450-2339
        • Principal Investigator:
          • Rehan Waheed, DO
    • Washington
      • Spokane, Washington, United States, 99201
        • Recruiting
        • Northwest Pain Care
        • Principal Investigator:
          • John Hatheway, MD
        • Contact:
          • Crystal Stevens
          • Phone Number: 509-863-9789

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
24 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celéri Health, Inc.

Collaborators

Medtronic

Investigators

  • Study Director: Michael Fishman, MD, Chief Medical Officer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2021

Primary Completion (Anticipated)

January 29, 2025

Study Completion (Anticipated)

January 29, 2025

Study Registration Dates

First Submitted

January 19, 2021

First Submitted That Met QC Criteria

January 21, 2021

First Posted (Actual)

January 27, 2021

Study Record Updates

Last Update Posted (Actual)

September 29, 2022

Last Update Submitted That Met QC Criteria

September 28, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPGRADE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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