Clinical trial NCT04601454: DTM (TM) Spinal Cord Stimulation (SCS) Study
Official title: DTM (TM) Low Energy Spinal Cord Stimulation (SCS) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2020-10-23
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: This post market study will measure the following:

* Visual Analog Scale
* Programming Parameters

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)

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: Baseline to 3 Months
Secondary outcomes:
measure: Programming Parameters: Frequency in Hertz (Hz)
timeFrame: 12 Month
measure: Programming Parameters: Pulse Width in Microseconds (µs)
timeFrame: 12 Month
measure: Programming Parameters: Amplitude (Intensity) in Milliamp (mA)
timeFrame: 12 Month
measure: Programming Parameters: Impedance Range in Ohms
timeFrame: 12 Month
Other outcomes:
Locations:
city: Walnut Creek
country: United States
facility: IPM Medical Group
state: California
city: Carmel
country: United States
facility: Goodman Campbell Brain and Spine
state: Indiana
city: Somerset
country: United States
facility: Drez One LLC
state: Kentucky
city: Huntersville
country: United States
facility: Carolinas Pain Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Novant Health
state: North Carolina
city: Oklahoma City
country: United States
facility: Oklahoma Pain Physicians
state: Oklahoma
city: Lancaster
country: United States
facility: Center for Interventional Pain and Spine
state: Pennsylvania
city: Sewickley
country: United States
facility: Pain Diagnostics and Interventional Care
state: Pennsylvania
city: Trevose
country: United States
facility: Delaware Valley Pain and Spine Institute
state: Pennsylvania
city: Conroe
country: United States
facility: The Woodlands Pain Institute
state: Texas
city: San Antonio
country: United States
facility: The Burkhart Research Institute for Orthopaedics
state: Texas
city: Shenandoah
country: United States
facility: Sprintz Center for Pain
state: Texas
city: Tyler
country: United States
facility: Precision Spine Care
state: Texas
Study officials:
affiliation: Medtronic
name: Restorative Therapies Group Restorative Therapies Group
role: STUDY_DIRECTOR
References: