Chronic PainNCT04601454

DTM (TM) Spinal Cord Stimulation (SCS) Study

A study testing Spinal Cord Stimulation System in people with Chronic Pain, run by MedtronicNeuro at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Pain
What is being tested?: Spinal Cord Stimulation System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 57 participants
Where: 13 sitesUnited States
Study dates: 5 Nov 2020to 25 Aug 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 9Show fewer

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

Who cannot join

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

Show all 9Show fewer

Serious drug-related behavioral issues
Unable to achieve supine or prone position
Classified as vulnerable or requires a legally authorized representative (LAR)

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

Goodman Campbell Brain and Spine
Carmel, Indiana, 46032
The Woodlands Pain Institute
Conroe, Texas, 77384
Carolinas Pain Center
Huntersville, North Carolina, 28078
Center for Interventional Pain and Spine
Lancaster, Pennsylvania, 17604
Oklahoma Pain Physicians
Oklahoma City, Oklahoma, 73120
The Burkhart Research Institute for Orthopaedics
San Antonio, Texas, 78216
Pain Diagnostics and Interventional Care
Sewickley, Pennsylvania, 15143
Sprintz Center for Pain
Shenandoah, Texas, 77384
Drez One LLC
Somerset, Kentucky, 42503
Delaware Valley Pain and Spine Institute
Trevose, Pennsylvania, 19053
Precision Spine Care
Tyler, Texas, 75701
IPM Medical Group
Walnut Creek, California, 94598
Novant Health
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: 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.

Read the detailed description

This post market study will measure the following:

Visual Analog Scale
Programming Parameters

Conditions: Chronic Pain
Being tested: Spinal Cord Stimulation System
Medical subject headings: Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Spinal Cord Stimulation SystemDevice
Also called Medtronic Intellis AdaptiveStim Neurostimulation System
Rechargeable Implanted neurostimulation system (neurostimulator and leads) with on-label stimulation parameters.

Study groups in NCT04601454
Study group	Role	What they receive
Spinal Cord Stimulation	Experimental	Enrolled subjects are implanted with a rechargeable spinal cord stimulation system that is activated and programmed to on-label parameters. Receives: Device: Spinal Cord Stimulation System

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline to 3 Months

Secondary outcomes (4)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 Month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Nov 202025 Aug 2022

First posted23 Oct 2020
Study start5 Nov 2020
Primary completion29 Nov 2021
Study completion25 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04601454
Sponsor's protocol ID: MDT20042
Status last verified: Feb 2023
First submitted: 5 Oct 2020
Last updated: 24 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: DTM (TM) Low Energy Spinal Cord Stimulation (SCS) Study
ClinicalTrials.gov ID: NCT04601454
Acronym / sponsor ID: MDT20042
Conditions: Chronic Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: MedtronicNeuroIndustry (pharma, biotech, devices)
Study start: 5 Nov 2020 (actual)
Primary completion: 29 Nov 2021 (actual)
Study completion: 25 Aug 2022 (actual)
First posted: 23 Oct 2020 (actual)
Results: Posted 24 Feb 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Spinal Cord Stimulation	Experimental	Device: Spinal Cord Stimulation SystemEnrolled subjects are implanted with a rechargeable spinal cord stimulation system that is activated and programmed to on-label parameters.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Spinal Cord Stimulation SystemAlso: Medtronic Intellis AdaptiveStim Neurostimulation SystemRechargeable Implanted neurostimulation system (neurostimulator and leads) with on-label stimulation parameters.	Device	Spinal Cord Stimulation

Primary outcome

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.

4 secondary outcomes

Programming Parameters: Frequency in Hertz (Hz)
Time frame: 12 Month
Programming Parameters: Pulse Width in Microseconds (µs)
Time frame: 12 Month
Programming Parameters: Amplitude (Intensity) in Milliamp (mA)
Time frame: 12 Month
Programming Parameters: Impedance Range in Ohms
Time frame: 12 Month

Results and safety

Results posted to the registry on 24 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Spinal Cord Stimulation	57	32

Primary outcome: Visual Analog Scale (VAS)

Time frame: Baseline to 3 Months. Mean (Standard Deviation). Unit: Centimeter

Measure	Spinal Cord Stimulation n = 32
Value	-3.9 (2.45)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events will be collected throughout the study duration, starting at the time of signing the informed consent through the subjects12 month visit, or study completion.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Spinal Cord Stimulation	1 of 57 (1.8%)	12 of 57 (21.1%)	0 of 57

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chronic Pain

Recruiting
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Enrolling by invitation
Efficacy of a Chronic Pain Treatment Prior to Gender-affirming Surgery
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Recruiting
Uncovering the Mechanism of Pain Relief by Peripheral Transcutaneous Magnetic Stimulation
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Multicomponent Exercise and Pain Science Education for Fall Prevention in Older Adults With Chronic Musculoskeletal Pain (MovePainFall)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Restorative Therapies Group Restorative Therapies Group study director

Medtronic

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Spinal Cord Stimulation System in people with Chronic Pain, run by MedtronicNeuro at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Scale (VAS) (time frame: Baseline to 3 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04601454.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023; AzTrials last refreshed its copy on 28 Oct 2026.