DTM (TM) Spinal Cord Stimulation (SCS) Study

DTM (TM) Low Energy 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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain
• Intervention / Treatment: Device: Spinal Cord Stimulation System

Detailed Description

This post market study will measure the following:

• Visual Analog Scale
• Programming Parameters

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Walnut Creek, California, United States, 94598
      • IPM Medical Group
  • Indiana
    • Carmel, Indiana, United States, 46032
      • Goodman Campbell Brain and Spine
  • Kentucky
    • Somerset, Kentucky, United States, 42503
      • Drez One LLC
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • Carolinas Pain Center
    • Winston-Salem, North Carolina, United States, 27103
      • Novant Health
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Oklahoma Pain Physicians
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17604
      • Center for Interventional Pain and Spine
    • Sewickley, Pennsylvania, United States, 15143
      • Pain Diagnostics and Interventional Care
    • Trevose, Pennsylvania, United States, 19053
      • Delaware Valley Pain and Spine Institute
  • Texas
    • Conroe, Texas, United States, 77384
      • The Woodlands Pain Institute
    • San Antonio, Texas, United States, 78216
      • The Burkhart Research Institute for Orthopaedics
    • Shenandoah, Texas, United States, 77384
      • Sprintz Center for Pain
    • Tyler, Texas, United States, 75701
      • Precision Spine Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spinal Cord Stimulation; Enrolled subjects are implanted with a rechargeable spinal cord stimulation system that is activated and programmed to on-label parameters.	Device: Spinal Cord Stimulation System; Rechargeable Implanted neurostimulation system (neurostimulator and leads) with on-label stimulation parameters.; Other Names: Medtronic Intellis AdaptiveStim Neurostimulation System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	12 Month

Collaborators and Investigators

• Sponsor: MedtronicNeuro
• Investigators: Study Director: Restorative Therapies Group Restorative Therapies Group, Medtronic

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2020
• Primary Completion (Actual): November 29, 2021
• Study Completion (Actual): August 25, 2022

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: October 19, 2020
• First Posted (Actual): October 23, 2020

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 21, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: MDT20042

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No