DTM (TM) Spinal Cord Stimulation (SCS) Study
CompletedNot applicableNCT04601454
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- DTM (TM) Low Energy Spinal Cord Stimulation (SCS) Study
- Conditions
- Interventions
- Device: Spinal Cord Stimulation System
- Sponsor
- MedtronicNeuro
- Start date
- 2020-11-05
- Primary completion
- 2021-11-29
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 13
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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)
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04601454