DTM (TM) Spinal Cord Stimulation (SCS) Study

Last updated: February 21, 2023
Sponsor: MedtronicNeuro
Overall Status: Completed

Phase

N/A

Condition

Pain

Chronic Pain

Treatment

N/A

Clinical Study ID

NCT04601454
MDT20042
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 andother types of pain

Exclusion

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 withsymptomatic neurogenic claudication
  • Currently enrolled or planning to enroll in an interventional clinical study thatcould potentially confound the study results
  • If female, is pregnant or is of child-bearing potential and unwilling to use amedically 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)

Study Design

Total Participants: 57
Study Start date:
November 05, 2020
Estimated Completion Date:
August 25, 2022

Study Description

This post market study will measure the following:

  • Visual Analog Scale

  • Programming Parameters

Connect with a study center

  • IPM Medical Group

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Goodman Campbell Brain and Spine

    Carmel, Indiana 46032
    United States

    Site Not Available

  • Drez One LLC

    Somerset, Kentucky 42503
    United States

    Site Not Available

  • Cell Bionics Institute

    Utica, New York 13502
    United States

    Site Not Available

  • Carolinas Pain Center

    Huntersville, North Carolina 28078
    United States

    Site Not Available

  • Novant Health

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Oklahoma Pain Physicians

    Oklahoma City, Oklahoma 73120
    United States

    Site Not Available

  • Center for Interventional Pain and Spine

    Lancaster, Pennsylvania 17604
    United States

    Site Not Available

  • Pain Diagnostics and Interventional Care

    Sewickley, Pennsylvania 15143
    United States

    Site Not Available

  • Delaware Valley Pain and Spine Institute

    Trevose, Pennsylvania 19053
    United States

    Site Not Available

  • The Woodlands Pain Institute

    Conroe, Texas 77384
    United States

    Site Not Available

  • The Burkhart Research Institute for Orthopaedics

    San Antonio, Texas 78216
    United States

    Site Not Available

  • Sprintz Center for Pain

    Shenandoah, Texas 77384
    United States

    Site Not Available

  • Precision Spine Care

    Tyler, Texas 75701
    United States

    Site Not Available

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