Differential Target Multiplexed Spinal Cord Stimulation (DTM-SCS®) Real World Outcomes
Study Details
Study Description
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 | Phase |
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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
Outcome Measures
Primary Outcome Measures
- 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. [24 months]
Secondary Outcome Measures
- To characterize the responder rate for pain by pain area per Percent Pain Relief for DTM-SCS® compared to participant baseline treatment. [24 months]
- To characterize the responder rate for pain by pain area per Numeric Rating Scale for DTM-SCS® compared to participant baseline treatment. [24 months]
- To evaluate the longitudinal characterization of objective posture and activity measures. [24 months]
Time spent in each activity/position (Intellis™ device data)
- To characterize Patient Global Impression of Change (PGIC) with neurostimulation. [24 months]
- To evaluate the performance of the DTM® pre-programming questionnaire in predicting outcome of DTM-SCS® programming. [24 months]
- To characterize the neuropathic pain quality using PROMIS-Neuropathic Pain Quality (PROMIS-PQ-Neuro) before and after treatment. [24 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Participant must provide written informed consent prior to any clinical study-related procedure.
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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.
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Participant has a permanent Medtronic Intellis™ neurostimulation system implanted or is planning to be implanted with a Medtronic Intellis™ or Vanta™ neurostimulation system.
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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:
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Participant is unable to provide written informed consent or to comply with study-related requirements, procedures, and visits.
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Participant is a profound responder for all pain areas to existing neurostimulation therapy (≥80% reported relief).
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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.
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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.
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Participant is pregnant or nursing.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Neuroversion | Anchorage | Alaska | United States | 99508 |
| 2 | Desert Sky Spine & Sports Medicine | Oro Valley | Arizona | United States | 85755 |
| 3 | Desert Sky Spine & Sports Medicine | Sierra Vista | Arizona | United States | 85635 |
| 4 | NuVation Pain Group - Buena Park | Buena Park | California | United States | 90621 |
| 5 | NuVation Pain Group - Los Angeles | Los Angeles | California | United States | 90020 |
| 6 | Spine and Sports Specialty Medical Group | Orange | California | United States | 92801 |
| 7 | Spine & Nerve Diagnostic Center - Roseville | Roseville | California | United States | 95661 |
| 8 | Florida Pain Medicine - Brandon | Brandon | Florida | United States | 33511 |
| 9 | Jax Spine & Pain Centers - Fleming Island | Fleming Island | Florida | United States | 32003 |
| 10 | Jax Spine & Pain Centers - UF North | Jacksonville | Florida | United States | 32218 |
| 11 | Jax Spine & Pain Centers - Jacksonville | Jacksonville | Florida | United States | 32256 |
| 12 | Florida Spine & Pain Specialists | Riverview | Florida | United States | 33569 |
| 13 | Jax Spine & Pain Centers -St. Augustine | Saint Augustine | Florida | United States | 32080 |
| 14 | Florida Pain Medicine - Wesley Chapel | Wesley Chapel | Florida | United States | 33544 |
| 15 | National Spine and Pain Centers - Winter Park, FL | Winter Park | Florida | United States | 32789 |
| 16 | Centurion Spine & Pain Centers (Jax Spine) | Waycross | Georgia | United States | 31501 |
| 17 | Millennium Pain Center (National Spine and Pain Centers - Bloomington, IL) | Bloomington | Illinois | United States | 61704 |
| 18 | National Spine and Pain Centers - National Harbor (Oxon Hill) | Oxon Hill | Maryland | United States | 20745 |
| 19 | National Spine and Pain Centers - Pikesville, MD | Pikesville | Maryland | United States | 21208 |
| 20 | Comprehensive and Interventional Pain Management | Henderson | Nevada | United States | 89052 |
| 21 | National Spine and Pain Centers - The Pain Management Center - Voorhees | Voorhees | New Jersey | United States | 08043 |
| 22 | Carolinas Research Institute - Mallard Creek | Charlotte | North Carolina | United States | 28262 |
| 23 | Carolinas Research Institute - Huntersville | Huntersville | North Carolina | United States | 28078 |
| 24 | Premier Pain Treatment Institute - Hillsboro | Hillsboro | Ohio | United States | 45133 |
| 25 | Premier Pain Treatment Institute - Loveland | Loveland | Ohio | United States | 45140 |
| 26 | Premier Pain Treatment Institute - Mt. Orab | Mount Orab | Ohio | United States | 45154 |
| 27 | Oklahoma Pain Physicians - Norman | Norman | Oklahoma | United States | 73072 |
| 28 | Oklahoma Pain Physicians - Oklahoma City | Oklahoma City | Oklahoma | United States | 73120 |
| 29 | Oklahoma Pain Physicians - Purcell | Purcell | Oklahoma | United States | 73080 |
| 30 | North Texas Orthopedics & Spine Center- Keller/Alliance | Fort Worth | Texas | United States | 76244 |
| 31 | North Texas Orthopedics & Spine Center - Grapevine | Grapevine | Texas | United States | 76051 |
| 32 | Precision Spine Care | Tyler | Texas | United States | 75701 |
| 33 | Valley Pain Consultants | Winchester | Virginia | United States | 22601 |
| 34 | Northwest Pain Care | Spokane | Washington | United States | 99201 |
Sponsors and Collaborators
- Celéri Health, Inc.
- Medtronic
Investigators
- Study Director: Michael Fishman, MD, Chief Medical Officer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- UPGRADE