DTM (TM) Spinal Cord Stimulation (SCS) Study

MedtronicNeuro57 enrolled

Overview

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.

This post market study will measure the following: * Visual Analog Scale * Programming Parameters

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Pain

Interventions

Spinal Cord Stimulation SystemDEVICE

Rechargeable Implanted neurostimulation system (neurostimulator and leads) with on-label stimulation parameters.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (13)

IPM Medical Group

Walnut Creek, California, United States

Goodman Campbell Brain and Spine

Carmel, Indiana, United States

Drez One LLC

Somerset, Kentucky, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline to 3 Months

Secondary Outcomes

Programming Parameters: Frequency in Hertz (Hz)

To characterize programming parameters associated with energy use. Subject's programmed frequency settings will be summarized using the minimum and maximum frequency across all subjects. Programming methodology for this study included up to four active program frequencies for each subject.

Time frame: 12 Month

Programming Parameters: Pulse Width in Microseconds (µs)

To characterize programming parameters associated with energy use. Subject's programmed Pulse Width settings will be summarized using the minimum and maximum Pulse Width across all subjects. Programming methodology for this study included up to four active program frequencies for each subject.

Time frame: 12 Month

Programming Parameters: Amplitude (Intensity) in Milliamp (mA)

To characterize programming parameters associated with energy use. Subject's programmed Amplitude settings will be summarized using the minimum and maximum Amplitude across all subjects. Programming methodology for this study included up to four active program frequencies for each subject.

Time frame: 12 Month

Programming Parameters: Impedance Range in Ohms

To characterize programming parameters associated with energy use. Subject's programmed Impedance settings will be summarized using the minimum and maximum Impedance across all subjects. Programming methodology for this study included up to four active program frequencies for each subject.

Data from ClinicalTrials.gov

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