Clinical trial NCT04725838: Differential Target Multiplexed Spinal Cord Stimulation (DTM-SCS®) Real World Outcomes
Official title: The UPGRADE Study: Real World Outcomes® of Differential Target Multiplexed (DTM-SCS®) Stimulation in Existing and New Medtronic Implants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Lead sponsor: Celéri Health, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2021-01-27
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 24 months
Secondary outcomes:
measure: To characterize the responder rate for pain by pain area per Percent Pain Relief for DTM-SCS® compared to participant baseline treatment.
timeFrame: 24 months
measure: To characterize the responder rate for pain by pain area per Numeric Rating Scale for DTM-SCS® compared to participant baseline treatment.
timeFrame: 24 months
measure: To evaluate the longitudinal characterization of objective posture and activity measures.
timeFrame: 24 months
measure: To characterize Patient Global Impression of Change (PGIC) with neurostimulation.
timeFrame: 24 months
measure: To evaluate the performance of the DTM® pre-programming questionnaire in predicting outcome of DTM-SCS® programming.
timeFrame: 24 months
measure: To characterize the neuropathic pain quality using PROMIS-Neuropathic Pain Quality (PROMIS-PQ-Neuro) before and after treatment.
timeFrame: 24 months
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Neuroversion
state: Alaska
city: Oro Valley
country: United States
facility: Desert Sky Spine & Sports Medicine
state: Arizona
city: Sierra Vista
country: United States
facility: Desert Sky Spine & Sports Medicine
state: Arizona
city: Buena Park
country: United States
facility: NuVation Pain Group - Buena Park
state: California
city: Los Angeles
country: United States
facility: NuVation Pain Group - Los Angeles
state: California
city: Orange
country: United States
facility: Spine and Sports Specialty Medical Group
state: California
city: Roseville
country: United States
facility: Spine & Nerve Diagnostic Center - Roseville
state: California
city: Brandon
country: United States
facility: Florida Pain Medicine - Brandon
state: Florida
city: Fleming Island
country: United States
facility: Jax Spine & Pain Centers - Fleming Island
state: Florida
city: Jacksonville
country: United States
facility: Jax Spine & Pain Centers - UF North
state: Florida
city: Jacksonville
country: United States
facility: Jax Spine & Pain Centers - Jacksonville
state: Florida
city: Riverview
country: United States
facility: Florida Spine & Pain Specialists
state: Florida
city: Saint Augustine
country: United States
facility: Jax Spine & Pain Centers -St. Augustine
state: Florida
city: Wesley Chapel
country: United States
facility: Florida Pain Medicine - Wesley Chapel
state: Florida
city: Winter Park
country: United States
facility: National Spine and Pain Centers - Winter Park, FL
state: Florida
city: Waycross
country: United States
facility: Centurion Spine & Pain Centers (Jax Spine)
state: Georgia
city: Bloomington
country: United States
facility: Millennium Pain Center (National Spine and Pain Centers - Bloomington, IL)
state: Illinois
city: Oxon Hill
country: United States
facility: National Spine and Pain Centers - National Harbor (Oxon Hill)
state: Maryland
city: Pikesville
country: United States
facility: National Spine and Pain Centers - Pikesville, MD
state: Maryland
city: Henderson
country: United States
facility: Comprehensive and Interventional Pain Management
state: Nevada
city: Voorhees
country: United States
facility: National Spine and Pain Centers - The Pain Management Center - Voorhees
state: New Jersey
city: Charlotte
country: United States
facility: Carolinas Research Institute - Mallard Creek
state: North Carolina
city: Huntersville
country: United States
facility: Carolinas Research Institute - Huntersville
state: North Carolina
city: Hillsboro
country: United States
facility: Premier Pain Treatment Institute - Hillsboro
state: Ohio
city: Loveland
country: United States
facility: Premier Pain Treatment Institute - Loveland
state: Ohio
city: Mount Orab
country: United States
facility: Premier Pain Treatment Institute - Mt. Orab
state: Ohio
city: Norman
country: United States
facility: Oklahoma Pain Physicians - Norman
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma Pain Physicians - Oklahoma City
state: Oklahoma
city: Purcell
country: United States
facility: Oklahoma Pain Physicians - Purcell
state: Oklahoma
city: Fort Worth
country: United States
facility: North Texas Orthopedics & Spine Center- Keller/Alliance
state: Texas
city: Grapevine
country: United States
facility: North Texas Orthopedics & Spine Center - Grapevine
state: Texas
city: Tyler
country: United States
facility: Precision Spine Care
state: Texas
city: Winchester
country: United States
facility: Valley Pain Consultants
state: Virginia
city: Spokane
country: United States
facility: Northwest Pain Care
state: Washington
Study officials:
affiliation: Chief Medical Officer
name: Michael Fishman, MD
role: STUDY_DIRECTOR
References: