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.

This post market study will measure the following:

• Visual Analog Scale
• Programming Parameters

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)