DTM (TM) Spinal Cord Stimulation (SCS) Study
DTM (TM) Low Energy Spinal Cord Stimulation (SCS) Study
1 other identifier
interventional
57
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable chronic-pain
Started Nov 2020
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 5, 2020
CompletedFirst Posted
Study publicly available on registry
October 23, 2020
CompletedStudy Start
First participant enrolled
November 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 29, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 25, 2022
CompletedResults Posted
Study results publicly available
February 24, 2023
CompletedFebruary 24, 2023
February 1, 2023
1.1 years
October 5, 2020
November 22, 2022
February 21, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Visual Analog Scale (VAS)
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.
Baseline to 3 Months
Secondary Outcomes (4)
Programming Parameters: Frequency in Hertz (Hz)
12 Month
Programming Parameters: Pulse Width in Microseconds (µs)
12 Month
Programming Parameters: Amplitude (Intensity) in Milliamp (mA)
12 Month
Programming Parameters: Impedance Range in Ohms
12 Month
Study Arms (1)
Spinal Cord Stimulation
EXPERIMENTALEnrolled subjects are implanted with a rechargeable spinal cord stimulation system that is activated and programmed to on-label parameters.
Interventions
Rechargeable Implanted neurostimulation system (neurostimulator and leads) with on-label stimulation parameters.
Eligibility Criteria
You may qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedtronicNeurolead
Study Sites (13)
IPM Medical Group
Walnut Creek, California, 94598, United States
Goodman Campbell Brain and Spine
Carmel, Indiana, 46032, United States
Drez One LLC
Somerset, Kentucky, 42503, United States
Carolinas Pain Center
Huntersville, North Carolina, 28078, United States
Novant Health
Winston-Salem, North Carolina, 27103, United States
Oklahoma Pain Physicians
Oklahoma City, Oklahoma, 73120, United States
Center for Interventional Pain and Spine
Lancaster, Pennsylvania, 17604, United States
Pain Diagnostics and Interventional Care
Sewickley, Pennsylvania, 15143, United States
Delaware Valley Pain and Spine Institute
Trevose, Pennsylvania, 19053, United States
The Woodlands Pain Institute
Conroe, Texas, 77384, United States
The Burkhart Research Institute for Orthopaedics
San Antonio, Texas, 78216, United States
Sprintz Center for Pain
Shenandoah, Texas, 77384, United States
Precision Spine Care
Tyler, Texas, 75701, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- DTM-LE Clinical Research Study Team
- Organization
- Medtronic
Study Officials
- STUDY DIRECTOR
Restorative Therapies Group Restorative Therapies Group
Medtronic
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 5, 2020
First Posted
October 23, 2020
Study Start
November 5, 2020
Primary Completion
November 29, 2021
Study Completion
August 25, 2022
Last Updated
February 24, 2023
Results First Posted
February 24, 2023
Record last verified: 2023-02