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

Chronic Pain Clinical Trial

Official title:

The UPGRADE Study: Real World Outcomes® of Differential Target Multiplexed (DTM-SCS®) Stimulation in Existing and New Medtronic Implants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04725838
• Other study ID #: UPGRADE
• Status: Recruiting
• Start date: January 29, 2021
• Est. completion date: January 29, 2025

Study information

• Verified date: September 2022
• Source: Celéri Health, Inc.
• Contact: Jean Myers
• Phone: 215-828-9070
• Email: jean[@]celerihealth.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: January 29, 2025
• Est. primary completion date: January 29, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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

Locations

Country	Name	City	State
United States	Neuroversion	Anchorage	Alaska
United States	Millennium Pain Center (National Spine and Pain Centers - Bloomington, IL)	Bloomington	Illinois
United States	Florida Pain Medicine - Brandon	Brandon	Florida
United States	NuVation Pain Group - Buena Park	Buena Park	California
United States	Carolinas Research Institute - Mallard Creek	Charlotte	North Carolina
United States	Jax Spine & Pain Centers - Fleming Island	Fleming Island	Florida
United States	North Texas Orthopedics & Spine Center- Keller/Alliance	Fort Worth	Texas
United States	North Texas Orthopedics & Spine Center - Grapevine	Grapevine	Texas
United States	Comprehensive and Interventional Pain Management	Henderson	Nevada
United States	Premier Pain Treatment Institute - Hillsboro	Hillsboro	Ohio
United States	Carolinas Research Institute - Huntersville	Huntersville	North Carolina
United States	Jax Spine & Pain Centers - Jacksonville	Jacksonville	Florida
United States	Jax Spine & Pain Centers - UF North	Jacksonville	Florida
United States	NuVation Pain Group - Los Angeles	Los Angeles	California
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	Spine and Sports Specialty Medical Group	Orange	California
United States	Desert Sky Spine & Sports Medicine	Oro Valley	Arizona
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	Oklahoma Pain Physicians - Purcell	Purcell	Oklahoma
United States	Florida Spine & Pain Specialists	Riverview	Florida
United States	Spine & Nerve Diagnostic Center - Roseville	Roseville	California
United States	Jax Spine & Pain Centers -St. Augustine	Saint Augustine	Florida
United States	Desert Sky Spine & Sports Medicine	Sierra Vista	Arizona
United States	Northwest Pain Care	Spokane	Washington
United States	Precision Spine Care	Tyler	Texas
United States	National Spine and Pain Centers - The Pain Management Center - Voorhees	Voorhees	New Jersey
United States	Centurion Spine & Pain Centers (Jax Spine)	Waycross	Georgia
United States	Florida Pain Medicine - Wesley Chapel	Wesley Chapel	Florida
United States	Valley Pain Consultants	Winchester	Virginia
United States	National Spine and Pain Centers - Winter Park, FL	Winter Park	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Celéri Health, Inc.	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To characterize the responder rate for pain by pain area per Percent Pain Relief for DTM-SCS® compared to participant baseline treatment.		24 months
Secondary	To characterize the responder rate for pain by pain area per Numeric Rating Scale for DTM-SCS® compared to participant baseline treatment.		24 months
Secondary	To evaluate the longitudinal characterization of objective posture and activity measures.	Time spent in each activity/position (Intellis™ device data)	24 months
Secondary	To characterize Patient Global Impression of Change (PGIC) with neurostimulation.		24 months
Secondary	To evaluate the performance of the DTM® pre-programming questionnaire in predicting outcome of DTM-SCS® programming.		24 months
Secondary	To characterize the neuropathic pain quality using PROMIS-Neuropathic Pain Quality (PROMIS-PQ-Neuro) before and after treatment.		24 months

External Links

•   Sponsor Website