DTM (TM) Spinal Cord Stimulation (SCS) Study

Medtronic

Status

Completed

Conditions

Chronic Pain

Treatments

Device: Spinal Cord Stimulation System

Study type

Interventional

Funder types

Industry

Identifiers

NCT04601454

MDT20042

Details and patient eligibility

About

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.

Full description

This post market study will measure the following:

Visual Analog Scale
Programming Parameters

Enrollment

57 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)