DTM (TM) Spinal Cord Stimulation (SCS) Study

Completed · Not applicable

Conditions studied: Chronic Pain

In brief

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.

Key facts

Study ID

NCT04601454

Run by

MedtronicNeuro

People needed

57

Starts

2020-11-05

Expected to finish

2022-08-25

Last updated by the study team

2023-02-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• IPM Medical Group — Walnut Creek, California, United States
• Goodman Campbell Brain and Spine — Carmel, Indiana, United States
• Drez One LLC — Somerset, Kentucky, United States
• Carolinas Pain Center — Huntersville, North Carolina, United States
• Novant Health — Winston-Salem, North Carolina, United States
• Oklahoma Pain Physicians — Oklahoma City, Oklahoma, United States
• Center for Interventional Pain and Spine — Lancaster, Pennsylvania, United States
• Pain Diagnostics and Interventional Care — Sewickley, Pennsylvania, United States
• Delaware Valley Pain and Spine Institute — Trevose, Pennsylvania, United States
• The Woodlands Pain Institute — Conroe, Texas, United States
• The Burkhart Research Institute for Orthopaedics — San Antonio, Texas, United States
• Sprintz Center for Pain — Shenandoah, Texas, United States
• Precision Spine Care — Tyler, Texas, United States

Full record on ClinicalTrials.gov

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