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

Completed

Conditions studied: Chronic Pain

In brief

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.

Key facts

Study ID

NCT04725838

Run by

Celéri Health, Inc.

People needed

255

Starts

2021-01-29

Expected to finish

2023-07-01

Last updated by the study team

2024-08-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Participant is unable to provide written informed consent or to comply with study-related requirements, procedures, and visits.
• Participant is a profound responder for all pain areas to existing neurostimulation therapy (≥80% reported relief).
• 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.
• 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.
• Participant is pregnant or nursing.

Where it is running

• 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

Full record on ClinicalTrials.gov

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