Differential Target Multiplexed Spinal Cord Stimulation (DTM-SCS®) Real World Outcomes
NCT ID: NCT04725838
Last Updated: 2024-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
255 participants
OBSERVATIONAL
2021-01-29
2023-07-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Interventions
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Medtronic Intellis™ and Vanta™
Differential Target Multiplexed (DTM®) programming using Medtronic's Intellis™ or Vanta™ Spinal Cord Stimulation systems
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
Celéri Health, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Fishman, MD
Role: STUDY_DIRECTOR
Chief Medical Officer
Locations
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Neuroversion
Anchorage, Alaska, United States
Desert Sky Spine & Sports Medicine
Oro Valley, Arizona, United States
Desert Sky Spine & Sports Medicine
Sierra Vista, Arizona, United States
NuVation Pain Group - Buena Park
Buena Park, California, United States
NuVation Pain Group - Los Angeles
Los Angeles, California, United States
Spine and Sports Specialty Medical Group
Orange, California, United States
Spine & Nerve Diagnostic Center - Roseville
Roseville, California, United States
Florida Pain Medicine - Brandon
Brandon, Florida, United States
Jax Spine & Pain Centers - Fleming Island
Fleming Island, Florida, United States
Jax Spine & Pain Centers - UF North
Jacksonville, Florida, United States
Jax Spine & Pain Centers - Jacksonville
Jacksonville, Florida, United States
Florida Spine & Pain Specialists
Riverview, Florida, United States
Jax Spine & Pain Centers -St. Augustine
Saint Augustine, Florida, United States
Florida Pain Medicine - Wesley Chapel
Wesley Chapel, Florida, United States
National Spine and Pain Centers - Winter Park, FL
Winter Park, Florida, United States
Centurion Spine & Pain Centers (Jax Spine)
Waycross, Georgia, United States
Millennium Pain Center (National Spine and Pain Centers - Bloomington, IL)
Bloomington, Illinois, United States
National Spine and Pain Centers - National Harbor (Oxon Hill)
Oxon Hill, Maryland, United States
National Spine and Pain Centers - Pikesville, MD
Pikesville, Maryland, United States
Comprehensive and Interventional Pain Management
Henderson, Nevada, United States
National Spine and Pain Centers - The Pain Management Center - Voorhees
Voorhees Township, New Jersey, United States
Carolinas Research Institute - Mallard Creek
Charlotte, North Carolina, United States
Carolinas Research Institute - Huntersville
Huntersville, North Carolina, United States
Premier Pain Treatment Institute - Hillsboro
Hillsboro, Ohio, United States
Premier Pain Treatment Institute - Loveland
Loveland, Ohio, United States
Premier Pain Treatment Institute - Mt. Orab
Mount Orab, Ohio, United States
Oklahoma Pain Physicians - Norman
Norman, Oklahoma, United States
Oklahoma Pain Physicians - Oklahoma City
Oklahoma City, Oklahoma, United States
Oklahoma Pain Physicians - Purcell
Purcell, Oklahoma, United States
North Texas Orthopedics & Spine Center- Keller/Alliance
Fort Worth, Texas, United States
North Texas Orthopedics & Spine Center - Grapevine
Grapevine, Texas, United States
Precision Spine Care
Tyler, Texas, United States
Valley Pain Consultants
Winchester, Virginia, United States
Northwest Pain Care
Spokane, Washington, United States
Countries
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Related Links
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Sponsor Website
Other Identifiers
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UPGRADE
Identifier Type: -
Identifier Source: org_study_id
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