DTM (TM) Spinal Cord Stimulation (SCS) Study

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04601454
• Other study ID #: MDT20042
• Status: Completed
• Phase: N/A
• Start date: November 5, 2020
• Est. completion date: August 25, 2022

Study information

• Verified date: February 2023
• Source: MedtronicNeuro
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This post market study will measure the following:

• Visual Analog Scale

• Programming Parameters

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: August 25, 2022
• Est. primary completion date: November 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Device:
• Spinal Cord Stimulation System
Rechargeable Implanted neurostimulation system (neurostimulator and leads) with on-label stimulation parameters.

Locations

Country	Name	City	State
United States	Goodman Campbell Brain and Spine	Carmel	Indiana
United States	The Woodlands Pain Institute	Conroe	Texas
United States	Carolinas Pain Center	Huntersville	North Carolina
United States	Center for Interventional Pain and Spine	Lancaster	Pennsylvania
United States	Oklahoma Pain Physicians	Oklahoma City	Oklahoma
United States	The Burkhart Research Institute for Orthopaedics	San Antonio	Texas
United States	Pain Diagnostics and Interventional Care	Sewickley	Pennsylvania
United States	Sprintz Center for Pain	Shenandoah	Texas
United States	Drez One LLC	Somerset	Kentucky
United States	Delaware Valley Pain and Spine Institute	Trevose	Pennsylvania
United States	Precision Spine Care	Tyler	Texas
United States	IPM Medical Group	Walnut Creek	California
United States	Novant Health	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
MedtronicNeuro

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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