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Completed

NCT Number: NCT04601454

DTM (TM) Spinal Cord Stimulation (SCS) Study

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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IPM Medical Group, Walnut Creek, California, United States

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About this study

This post market study will measure the following:

  • Visual Analog Scale
  • Programming Parameters

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Spinal cord stimulation system

Device

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

Other names: Medtronic Intellis AdaptiveStim Neurostimulation System

Primary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: Baseline to 3 Months

    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.

Secondary outcomes

  1. Programming Parameters: Frequency in Hertz (Hz)

    Time frame: 12 Month

    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.

  2. Programming Parameters: Pulse Width in Microseconds (µs)

    Time frame: 12 Month

    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.

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

    Time frame: 12 Month

    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.

  4. Programming Parameters: Impedance Range in Ohms

    Time frame: 12 Month

    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.

Sponsors and collaborators

Lead sponsor

MedtronicNeuro

Industry

Registry information

Official study title

DTM (TM) Low Energy Spinal Cord Stimulation (SCS) Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Oct 23, 2020
Registry last updated
Feb 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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