NCT04601454CompletedNot Applicable
DTM (TM) Low Energy Spinal Cord Stimulation (SCS) Study
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- MedtronicNeuro
- Enrollment
- 57
- Locations
- 26
- Primary Endpoint
- Visual Analog Scale (VAS)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Visual Analog Scale (VAS)
Time Frame: Baseline to 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.
Secondary Outcomes
- Programming Parameters: Pulse Width in Microseconds (µs)(12 Month)
- Programming Parameters: Amplitude (Intensity) in Milliamp (mA)(12 Month)
- Programming Parameters: Impedance Range in Ohms(12 Month)
- Programming Parameters: Frequency in Hertz (Hz)(12 Month)
Investigators
Study Sites (26)
Loading locations...
Similar Trials
Completed
Not Applicable
A Prospective, Multicentre Study of Low Dose Targeted Drug Delivery (TDD) for Chronic Back Pain Patients who have Failed Spinal Cord StimulatioChronic primary back painAnaesthesiology - Pain managementNeurological - Other neurological disordersMusculoskeletal - Other muscular and skeletal disordersACTRN12619001139167Genesis Research Services9
Recruiting
Not Applicable
Differential Target Multiplexed Spinal Cord StimulationFailed Back Surgery SyndromePersistent Spinal Pain Syndrome Type 2NCT05068011Moens Maarten250
Recruiting
Unknown
Study of new stimulation for neuropathic pain following a spinal cord lesioeuropathic pain following a spinal cord lesionJPRN-jRCT1042220093Saito Ryuta10
Completed
Not Applicable
Spinal Cord Stimulation in Chemotherapy Induced NeuropathyChemotherapy-induced Peripheral NeuropathyNCT03764514Prisma Health-Upstate5
Completed
Not Applicable
Wireless Spinal Cord Stimulation for Chronic PainBack PainNCT02514590Curonix LLC49