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

NCT04725838 | Completed

• 1 other identifier: UPGRADE
• Study Type: observational
• Target: 255
• Locations: 1 country
• Sites: 34

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.

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• 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

Interventions

Medtronic Intellis™ and Vanta™ DEVICE

Differential Target Multiplexed (DTM®) programming using Medtronic's Intellis™ or Vanta™ Spinal Cord Stimulation systems

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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.

Sponsors & Collaborators

• Celéri Health, Inc.: lead
• Medtronic: collaborator

Study Sites (34)

Neuroversion

Anchorage, Alaska, 99508, United States

Location

Desert Sky Spine & Sports Medicine

Oro Valley, Arizona, 85755, United States

Location

Desert Sky Spine & Sports Medicine

Sierra Vista, Arizona, 85635, United States

Location

NuVation Pain Group - Buena Park

Buena Park, California, 90621, United States

Location

NuVation Pain Group - Los Angeles

Los Angeles, California, 90020, United States

Location

Spine and Sports Specialty Medical Group

Orange, California, 92801, United States

Location

Spine & Nerve Diagnostic Center - Roseville

Roseville, California, 95661, United States

Location

Florida Pain Medicine - Brandon

Brandon, Florida, 33511, United States

Location

Jax Spine & Pain Centers - Fleming Island

Fleming Island, Florida, 32003, United States

Location

Jax Spine & Pain Centers - UF North

Jacksonville, Florida, 32218, United States

Location

Jax Spine & Pain Centers - Jacksonville

Jacksonville, Florida, 32256, United States

Location

Florida Spine & Pain Specialists

Riverview, Florida, 33569, United States

Location

Jax Spine & Pain Centers -St. Augustine

Saint Augustine, Florida, 32080, United States

Location

Florida Pain Medicine - Wesley Chapel

Wesley Chapel, Florida, 33544, United States

Location

National Spine and Pain Centers - Winter Park, FL

Winter Park, Florida, 32789, United States

Location

Centurion Spine & Pain Centers (Jax Spine)

Waycross, Georgia, 31501, United States

Location

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

Bloomington, Illinois, 61704, United States

Location

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

Oxon Hill, Maryland, 20745, United States

Location

National Spine and Pain Centers - Pikesville, MD

Pikesville, Maryland, 21208, United States

Location

Comprehensive and Interventional Pain Management

Henderson, Nevada, 89052, United States

Location

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

Voorhees Township, New Jersey, 08043, United States

Location

Carolinas Research Institute - Mallard Creek

Charlotte, North Carolina, 28262, United States

Location

Carolinas Research Institute - Huntersville

Huntersville, North Carolina, 28078, United States

Location

Premier Pain Treatment Institute - Hillsboro

Hillsboro, Ohio, 45133, United States

Location

Premier Pain Treatment Institute - Loveland

Loveland, Ohio, 45140, United States

Location

Premier Pain Treatment Institute - Mt. Orab

Mount Orab, Ohio, 45154, United States

Location

Oklahoma Pain Physicians - Norman

Norman, Oklahoma, 73072, United States

Location

Oklahoma Pain Physicians - Oklahoma City

Oklahoma City, Oklahoma, 73120, United States

Location

Oklahoma Pain Physicians - Purcell

Purcell, Oklahoma, 73080, United States

Location

North Texas Orthopedics & Spine Center- Keller/Alliance

Fort Worth, Texas, 76244, United States

Location

North Texas Orthopedics & Spine Center - Grapevine

Grapevine, Texas, 76051, United States

Location

Precision Spine Care

Tyler, Texas, 75701, United States

Location

Valley Pain Consultants

Winchester, Virginia, 22601, United States

Location

Northwest Pain Care

Spokane, Washington, 99201, United States

Location

Related Links

• Sponsor Website

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Fishman, MD

  Chief Medical Officer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 27, 2021
• Study Start: January 29, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (34)