N/A
N=57
DTM (TM) Spinal Cord Stimulation (SCS) Study
Chronic Pain
Bottom Line
View on ClinicalTrials.gov: NCT04601454 ↗Enrolled (actual)
57
Serious AEs
1.8%
Results posted
Feb 2023
Primary outcome: Primary: Visual Analog Scale (VAS) — -3.9 Centimeter
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Spinal Cord Stimulation System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- MedtronicNeuro
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analog Scale (VAS) |
-3.9 | — |
| SECONDARY Programming Parameters: Frequency in Hertz (Hz) |
250.0; 300.0 | — |
| SECONDARY Programming Parameters: Pulse Width in Microseconds (µs) |
200.0; 200.0 | — |
| SECONDARY Programming Parameters: Amplitude (Intensity) in Milliamp (mA) |
0.70; 7.3 | — |
| SECONDARY Programming Parameters: Impedance Range in Ohms |
670.0; 2,020.0 | — |
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 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)
Data sourced from ClinicalTrials.gov (NCT04601454). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.