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DTM-LE Spinal Cord Stimulation (SCS) Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04601454
Recruitment Status : Active, not recruiting
First Posted : October 23, 2020
Last Update Posted : May 3, 2022
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

Tracking Information
First Submitted Date  ICMJE October 5, 2020
First Posted Date  ICMJE October 23, 2020
Last Update Posted Date May 3, 2022
Actual Study Start Date  ICMJE November 5, 2020
Actual Primary Completion Date November 29, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2020)		 Visual Analog Scale [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2020)
  • Programming parameters: frequency in hertz (Hz) [ Time Frame: 12 months ]
    To characterize programming parameters associated with energy use. Subject's programmed frequency settings will be summarized. Programming parameters will be collected during the device trial and at the Device Implant, Device Activation, 1-, 3-, 6-, and 12-Month visits. Programming parameters will also be collected at unscheduled visits, as applicable.
  • Programming parameters: pulse width in microseconds (µs) [ Time Frame: 12 months ]
    To characterize programming parameters associated with energy use. Subject's programmed pulse width settings will be summarized. Programming parameters will be collected during the device trial and at the Device Implant, Device Activation, 1-, 3-, 6-, and 12-Month visits. Programming parameters will also be collected at unscheduled visits, as applicable.
  • Programming parameters: amplitude (intensity) in milliamp (mA) [ Time Frame: 12 months ]
    To characterize programming parameters associated with energy use. Subject's programmed amplitude settings will be summarized. Programming parameters will be collected during the device trial and at the Device Implant, Device Activation, 1-, 3-, 6-, and 12-Month visits. Programming parameters will also be collected at unscheduled visits, as applicable.
  • Programming parameters: impedance range in ohms [ Time Frame: 12 months ]
    To characterize programming parameters associated with energy use. Subject's impedance ranges with programmed settings will be summarized. Programming parameters will be collected during the device trial and at the Device Implant, Device Activation, 1-, 3-, 6-, and 12-Month visits. Programming parameters will also be collected at unscheduled visits, as applicable.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE DTM-LE Spinal Cord Stimulation (SCS) Study
Official Title  ICMJE DTM Low Energy Spinal Cord Stimulation (SCS) Study
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Pain
Intervention  ICMJE Device: Spinal Cord Stimulation System
Implanted neurostimulation system (neurostimulator and leads) with on-label stimulation parameters.
Other Name: Medtronic Intellis AdaptiveStim Neurostimulation System
Study Arms  ICMJE Experimental: Spinal Cord Stimulation
Enrolled subjects are implanted with a spinal cord stimulation system that is activated and programmed to on-label parameters.
Intervention: Device: Spinal Cord Stimulation System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 16, 2021)		 57
Original Estimated Enrollment  ICMJE
 (submitted: October 19, 2020)		 56
Estimated Study Completion Date  ICMJE October 11, 2022
Actual Primary Completion Date November 29, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04601454
Other Study ID Numbers  ICMJE MDT20042
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MedtronicNeuro
Study Sponsor  ICMJE MedtronicNeuro
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account MedtronicNeuro
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP