Chronic PainNCT04725838
Differential Target Multiplexed Spinal Cord Stimulation (DTM-SCS®) Real World Outcomes
An observational study of Chronic Pain, run by Celéri Health, Inc. at 34 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Medtronic Intellis™ and Vanta™
- Type of treatment
- Medical device
- How many people
- 255 participants
- Where
- 34 sitesUnited States
- Study dates
- 29 Jan 2021to 1 Jul 2023
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Neuroversion
Anchorage, Alaska, 99508
Millennium Pain Center (National Spine and Pain Centers - Bloomington, IL)
Bloomington, Illinois, 61704
Florida Pain Medicine - Brandon
Brandon, Florida, 33511
NuVation Pain Group - Buena Park
Buena Park, California, 90621
Carolinas Research Institute - Mallard Creek
Charlotte, North Carolina, 28262
Jax Spine & Pain Centers - Fleming Island
Fleming Island, Florida, 32003
North Texas Orthopedics & Spine Center- Keller/Alliance
Fort Worth, Texas, 76244
North Texas Orthopedics & Spine Center - Grapevine
Grapevine, Texas, 76051
Comprehensive and Interventional Pain Management
Henderson, Nevada, 89052
Premier Pain Treatment Institute - Hillsboro
Hillsboro, Ohio, 45133
Carolinas Research Institute - Huntersville
Huntersville, North Carolina, 28078
Jax Spine & Pain Centers - UF North
Jacksonville, Florida, 32218
Jax Spine & Pain Centers - Jacksonville
Jacksonville, Florida, 32256
NuVation Pain Group - Los Angeles
Los Angeles, California, 90020
Premier Pain Treatment Institute - Loveland
Loveland, Ohio, 45140
Premier Pain Treatment Institute - Mt. Orab
Mount Orab, Ohio, 45154
Oklahoma Pain Physicians - Norman
Norman, Oklahoma, 73072
Oklahoma Pain Physicians - Oklahoma City
Oklahoma City, Oklahoma, 73120
Spine and Sports Specialty Medical Group
Orange, California, 92801
Desert Sky Spine & Sports Medicine
Oro Valley, Arizona, 85755
National Spine and Pain Centers - National Harbor (Oxon Hill)
Oxon Hill, Maryland, 20745
National Spine and Pain Centers - Pikesville, MD
Pikesville, Maryland, 21208
Oklahoma Pain Physicians - Purcell
Purcell, Oklahoma, 73080
Florida Spine & Pain Specialists
Riverview, Florida, 33569
Spine & Nerve Diagnostic Center - Roseville
Roseville, California, 95661
Jax Spine & Pain Centers -St. Augustine
Saint Augustine, Florida, 32080
Desert Sky Spine & Sports Medicine
Sierra Vista, Arizona, 85635
Northwest Pain Care
Spokane, Washington, 99201
Precision Spine Care
Tyler, Texas, 75701
National Spine and Pain Centers - The Pain Management Center - Voorhees
Voorhees Township, New Jersey, 08043
Centurion Spine & Pain Centers (Jax Spine)
Waycross, Georgia, 31501
Florida Pain Medicine - Wesley Chapel
Wesley Chapel, Florida, 33544
Valley Pain Consultants
Winchester, Virginia, 22601
National Spine and Pain Centers - Winter Park, FL
Winter Park, Florida, 32789
About this study
Official title: The UPGRADE Study: Real World Outcomes® of Differential Target Multiplexed (DTM-SCS®) Stimulation in Existing and New Medtronic Implants
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Medtronic Intellis™ and Vanta™
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Intellis™ and Vanta™Device
Differential Target Multiplexed (DTM®) programming using Medtronic's Intellis™ or Vanta™ Spinal Cord Stimulation systems
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 24 months
To characterize the responder rate for pain by pain area per Numeric Rating Scale for DTM-SCS® compared to participant baseline treatment.
Measured: 24 months
To evaluate the longitudinal characterization of objective posture and activity measures.
Time spent in each activity/position (Intellis™ device data)
Measured: 24 months
To characterize Patient Global Impression of Change (PGIC) with neurostimulation.
Measured: 24 months
To evaluate the performance of the DTM® pre-programming questionnaire in predicting outcome of DTM-SCS® programming.
Measured: 24 months
To characterize the neuropathic pain quality using PROMIS-Neuropathic Pain Quality (PROMIS-PQ-Neuro) before and after treatment.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start29 Jan 2021
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 255 participants (actual)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Celéri Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- Michael Fishman, MD, Study director, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04725838
- Sponsor's protocol ID
- UPGRADE
- Status last verified
- Aug 2024
- First submitted
- 19 Jan 2021
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The UPGRADE Study: Real World Outcomes® of Differential Target Multiplexed (DTM-SCS®) Stimulation in Existing and New Medtronic Implants
- ClinicalTrials.gov ID
- NCT04725838
- Acronym / sponsor ID
- UPGRADE
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Celéri Health, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Medtronic
- Study start
- 29 Jan 2021 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic Intellis™ and Vanta™Differential Target Multiplexed (DTM®) programming using Medtronic's Intellis™ or Vanta™ Spinal Cord Stimulation systems | Device | – |
Primary outcome
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.
Time frame: 24 months
6 secondary outcomes
To characterize the responder rate for pain by pain area per Percent Pain Relief for DTM-SCS® compared to participant baseline treatment.
Time frame: 24 months
To characterize the responder rate for pain by pain area per Numeric Rating Scale for DTM-SCS® compared to participant baseline treatment.
Time frame: 24 months
To evaluate the longitudinal characterization of objective posture and activity measures.
Time frame: 24 months
To characterize Patient Global Impression of Change (PGIC) with neurostimulation.
Time frame: 24 months
To evaluate the performance of the DTM® pre-programming questionnaire in predicting outcome of DTM-SCS® programming.
Time frame: 24 months
To characterize the neuropathic pain quality using PROMIS-Neuropathic Pain Quality (PROMIS-PQ-Neuro) before and after treatment.
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Sponsor WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Fishman, MD study director
Chief Medical Officer
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Celéri Health, Inc. at 34 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.