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DTM (TM) Spinal Cord Stimulation (SCS) Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04601454
Recruitment Status : Completed
First Posted : October 23, 2020
Results First Posted : February 24, 2023
Last Update Posted : February 24, 2023
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

Study Description
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Brief Summary:
Prospective, multi-center, open-label, post-market study to evaluate the efficacy and energy use of a low energy DTM™ (DTM-LE) SCS therapy for pain relief.

Condition or disease Intervention/treatment Phase
Chronic Pain Device: Spinal Cord Stimulation System Not Applicable

Detailed Description:

This post market study will measure the following:

  • Visual Analog Scale
  • Programming Parameters
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: DTM (TM) Low Energy Spinal Cord Stimulation (SCS) Study
Actual Study Start Date : November 5, 2020
Actual Primary Completion Date : November 29, 2021
Actual Study Completion Date : August 25, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Spinal Cord Stimulation
Enrolled subjects are implanted with a rechargeable spinal cord stimulation system that is activated and programmed to on-label parameters.
 Device: Spinal Cord Stimulation System
Rechargeable Implanted neurostimulation system (neurostimulator and leads) with on-label stimulation parameters.
Other Name: Medtronic Intellis AdaptiveStim Neurostimulation System


Outcome Measures
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Primary Outcome Measures :
  1. Visual Analog Scale (VAS) [ Time Frame: Baseline to 3 Months ]
    To characterize changes in overall (back and leg) pain intensity. Pain will be assessed using a VAS (0-10 cm) with 0 cm meaning "no pain" and 10 cm meaning "worst pain imaginable". Overall pain is defined as a combination of back and leg pain, but not pain from other body parts. Subjects will be asked to report their average pain intensity that is related to their SCS device treatment "in the last 24 hours" by marking a line perpendicular to the VAS line at the point that represents their pain intensity.


Secondary Outcome Measures :
  1. Programming Parameters: Frequency in Hertz (Hz) [ Time Frame: 12 Month ]
    To characterize programming parameters associated with energy use. Subject's programmed frequency settings will be summarized using the minimum and maximum frequency across all subjects. Programming methodology for this study included up to four active program frequencies for each subject.

  2. Programming Parameters: Pulse Width in Microseconds (µs) [ Time Frame: 12 Month ]
    To characterize programming parameters associated with energy use. Subject's programmed Pulse Width settings will be summarized using the minimum and maximum Pulse Width across all subjects. Programming methodology for this study included up to four active program frequencies for each subject.

  3. Programming Parameters: Amplitude (Intensity) in Milliamp (mA) [ Time Frame: 12 Month ]
    To characterize programming parameters associated with energy use. Subject's programmed Amplitude settings will be summarized using the minimum and maximum Amplitude across all subjects. Programming methodology for this study included up to four active program frequencies for each subject.

  4. Programming Parameters: Impedance Range in Ohms [ Time Frame: 12 Month ]
    To characterize programming parameters associated with energy use. Subject's programmed Impedance settings will be summarized using the minimum and maximum Impedance across all subjects. Programming methodology for this study included up to four active program frequencies for each subject.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Willing and able to provide signed and dated informed consent
  • Capable of comprehending and consenting in English
  • Candidate per labeling for an SCS system as an aid in the management of chronic, intractable pain of the trunk and/or limbs
  • Has moderate to severe back and leg pain
  • Stable pain medications for back and leg pain for at least 28 days prior to enrollment
  • Willing and able to comply with all study procedures and visits
  • Willing and able to not increase their pain medications through the 3-Month visit
  • Able to differentiate between pain associated with the indication for SCS implant and other types of pain

Exclusion Criteria:

  • Previously trialed or implanted with a stimulator or intrathecal drug delivery system
  • Expected to be inaccessible for follow-up
  • Current diagnosis of moderate to severe central lumbar spinal stenosis with symptomatic neurogenic claudication
  • Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results
  • If female, is pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study
  • Has untreated major psychiatric comorbidity
  • Serious drug-related behavioral issues
  • Unable to achieve supine or prone position
  • Classified as vulnerable or requires a legally authorized representative (LAR)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04601454


Locations
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United States, California
IPM Medical Group
Walnut Creek, California, United States, 94598
United States, Indiana
Goodman Campbell Brain and Spine
Carmel, Indiana, United States, 46032
United States, Kentucky
Drez One LLC
Somerset, Kentucky, United States, 42503
United States, North Carolina
Carolinas Pain Center
Huntersville, North Carolina, United States, 28078
Novant Health
Winston-Salem, North Carolina, United States, 27103
United States, Oklahoma
Oklahoma Pain Physicians
Oklahoma City, Oklahoma, United States, 73120
United States, Pennsylvania
Center for Interventional Pain and Spine
Lancaster, Pennsylvania, United States, 17604
Pain Diagnostics and Interventional Care
Sewickley, Pennsylvania, United States, 15143
Delaware Valley Pain and Spine Institute
Trevose, Pennsylvania, United States, 19053
United States, Texas
The Woodlands Pain Institute
Conroe, Texas, United States, 77384
The Burkhart Research Institute for Orthopaedics
San Antonio, Texas, United States, 78216
Sprintz Center for Pain
Shenandoah, Texas, United States, 77384
Precision Spine Care
Tyler, Texas, United States, 75701
Sponsors and Collaborators
MedtronicNeuro
Investigators
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Study Director: Restorative Therapies Group Restorative Therapies Group Medtronic
  Study Documents (Full-Text)

Documents provided by MedtronicNeuro:
Study Protocol  [PDF] February 25, 2021
Statistical Analysis Plan  [PDF] November 28, 2022

More Information
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Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT04601454    
Other Study ID Numbers: MDT20042
First Posted: October 23, 2020    Key Record Dates
Results First Posted: February 24, 2023
Last Update Posted: February 24, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Chronic Pain
Pain
Neurologic Manifestations