DTM (TM) Spinal Cord Stimulation (SCS) Study
Primary Purpose
Chronic Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spinal Cord Stimulation System
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
Eligibility Criteria
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)
Sites / Locations
- IPM Medical Group
- Goodman Campbell Brain and Spine
- Drez One LLC
- Carolinas Pain Center
- Novant Health
- Oklahoma Pain Physicians
- Center for Interventional Pain and Spine
- Pain Diagnostics and Interventional Care
- Delaware Valley Pain and Spine Institute
- The Woodlands Pain Institute
- The Burkhart Research Institute for Orthopaedics
- Sprintz Center for Pain
- Precision Spine Care
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Spinal Cord Stimulation
Arm Description
Enrolled subjects are implanted with a rechargeable spinal cord stimulation system that is activated and programmed to on-label parameters.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04601454
Brief Title
DTM (TM) Spinal Cord Stimulation (SCS) Study
Official Title
DTM (TM) Low Energy Spinal Cord Stimulation (SCS) Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 5, 2020 (Actual)
Primary Completion Date
November 29, 2021 (Actual)
Study Completion Date
August 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedtronicNeuro
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spinal Cord Stimulation
Arm Type
Experimental
Arm Description
Enrolled subjects are implanted with a rechargeable spinal cord stimulation system that is activated and programmed to on-label parameters.
Intervention Type
Device
Intervention Name(s)
Spinal Cord Stimulation System
Other Intervention Name(s)
Medtronic Intellis AdaptiveStim Neurostimulation System
Intervention Description
Rechargeable Implanted neurostimulation system (neurostimulator and leads) with on-label stimulation parameters.
Primary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Description
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 Outcome Measure Information:
Title
Programming Parameters: Frequency in Hertz (Hz)
Description
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
Title
Programming Parameters: Pulse Width in Microseconds (µs)
Description
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
Title
Programming Parameters: Amplitude (Intensity) in Milliamp (mA)
Description
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
Title
Programming Parameters: Impedance Range in Ohms
Description
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.
Time Frame
12 Month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Restorative Therapies Group Restorative Therapies Group
Organizational Affiliation
Medtronic
Official's Role
Study Director
Facility Information:
Facility Name
IPM Medical Group
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Goodman Campbell Brain and Spine
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
Drez One LLC
City
Somerset
State/Province
Kentucky
ZIP/Postal Code
42503
Country
United States
Facility Name
Carolinas Pain Center
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Novant Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Oklahoma Pain Physicians
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Center for Interventional Pain and Spine
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
Pain Diagnostics and Interventional Care
City
Sewickley
State/Province
Pennsylvania
ZIP/Postal Code
15143
Country
United States
Facility Name
Delaware Valley Pain and Spine Institute
City
Trevose
State/Province
Pennsylvania
ZIP/Postal Code
19053
Country
United States
Facility Name
The Woodlands Pain Institute
City
Conroe
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
The Burkhart Research Institute for Orthopaedics
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78216
Country
United States
Facility Name
Sprintz Center for Pain
City
Shenandoah
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
Precision Spine Care
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
12. IPD Sharing Statement
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DTM (TM) Spinal Cord Stimulation (SCS) Study
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