DTM (TM) Spinal Cord Stimulation (SCS) Study

Study Overview
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Brief Summary
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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
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This post market study will measure the following: Visual Analog Scale Programming Parameters

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

Conditions
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Chronic Pain

Intervention / Treatment
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* Device: Spinal Cord Stimulation System


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinal Cord Stimulation<br>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<br>* Rechargeable Implanted neurostimulation system (neurostimulator and leads) with on-label stimulation parameters.<br>* Other names: Medtronic Intellis AdaptiveStim Neurostimulation System;|

What is the study measuring?
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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 |