Medtronic Closed-Loop Spinal Cord Stimulation System

A study testing Inceptiv in people with Low Back Pain and Leg Pain, run by MedtronicNeuro at 7 sites in Australia.

Completed

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

Trial summary

The purpose of the study is to further understand the closed-loop feature in chronically implanted patients by characterizing the efficacy of the next generation, spinal cord stimulator. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Low Back Pain, Leg Pain, Upper Limb Pain
What is being tested?: Inceptiv
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 94 participants
Where: 7 sitesAustralia
Study dates: 30 Nov 2021to 28 Jul 2025
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
Candidate is undergoing Medtronic SCS device trial for chronic, intractable pain of the trunk and/or limbs
If being treated for low-back and/or leg pain,
the baseline overall^ Visual Analog Scale is ≥ 60 mm and
baseline back and/or leg pain Visual Analog Scale is ≥60 mm. ^Average overall pain in the back and/or leg in the 72 hours prior to the baseline visit, measured using Visual Analog Scale.
If being treated for upper limb pain - baseline Visual Analog Scale is ≥ 60 mm for upper limb pain

Show all 9Show fewer

On stable (no change in dose, route, or frequency) prescribed pain medications being used for back and leg pain or upper limb pain, as determined by the investigator, for at least 28 days prior to device trial
Willing and able to provide signed and dated informed consent
Willing and able to comply with all study procedures and visits

Who cannot join

Indicated for an SCS device to treat stable intractable Angina Pectoris or Peripheral Vascular Disease of Fontaine Stage III or higher
Previously trialed or implanted with spinal cord stimulator, peripheral or vagus nerve stimulator, deep brain stimulator or an implantable intrathecal drug delivery system
Currently participating, or plans to participate, in another investigational study unless written approval is provided by the Medtronic study team
Major psychiatric comorbidity or other progressive diseases that may confound study results, as determined by the Investigator
Serious drug-related behavioral issues (e.g. alcohol dependency, illegal substance abuse), as determined by the Investigator
Pregnant or planning on becoming pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile, or be at least 2 years post-menopausal)
Be involved in an injury claim or under current litigation

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

Australia7 sites

Sydney Pain Specialists
Bella Vista, New South Wales, 2153
Genesis Research Services
Broadmeadow, New South Wales, 2292
Australian Medical Research
Hurstville, New South Wales, 2220
Precision Brain Spine and Pain Center
Kew, Victoria, 3101
Sunshine Coast Clinical Research
Noosa, Queensland, 4567
Royal North Shore Hospital
Saint Leonards, New South Wales, 2065
Sydney Pain Research Centre
Wahroonga, New South Wales, 2076

Other trials in Australia

About this study

Official title: Evaluation of Long-term Patient Experience With a Medtronic Closed-Loop Spinal Cord Stimulation System

The purpose of the study is to further understand the closed-loop feature in chronically implanted patients by characterizing the efficacy of the next generation, spinal cord stimulator.

Conditions: Low Back Pain, Leg Pain, Upper Limb Pain
Being tested: Inceptiv
Medical subject headings: Low Back Pain

What participants receive

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

InceptivDevice
Implantable Neurostimulator with Neuro Sense

Study groups in NCT05177354
Study group	Role	What they receive
Treatment	Experimental	Not described Receives: Device: Inceptiv

What is being measured

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

Reduction in Overstimulation Sensation
The primary outcome is the proportion of low-back and/or leg pain subjects whose average overstimulation intensity score with Closed Loop On is less than their average overstimulation intensity score with Closed Loop Off. During in-clinic testing, subjects perform protocol prescribed activities and rate the intensity of the sensations on a 5-point Likert scale with both Closed Loop On and Off. The average overstimulation intensity scores within each subject are calculated separately for Closed Loop On and Off, and the proportion of subjects with a lower average overstimulation intensity score during Closed Loop On compared to their overstimulation intensity score during Closed Loop Off is calculated with a one-sided 97.5% lower bound.
Measured: 30 days from device activation

Secondary outcomes (3)

Responder Rate for Treatment of Overall Pain
Responder rate defined as a reduction in Overall (back/leg) pain VAS of at least 50%.
Measured: 3 months from device activation
Responder Rate for Treatment of Low-back Pain
Responder rate defined as a reduction in back pain VAS of at least 50%.
Measured: 3 months from device activation
Responder Rate for Treatment of Leg Pain
Responder rate defined as a reduction in leg pain VAS of at least 50%.
Measured: 3 months from device activation

Timeline

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

30 Nov 202128 Jul 2025

First posted4 Jan 2022
Study start30 Nov 2021
Primary completion4 May 2023
Study completion28 Jul 2025

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.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Low Back 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: 94 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05177354
Sponsor's protocol ID: MDT21017
Status last verified: Oct 2025
First submitted: 30 Nov 2021
Last updated: 5 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Mohabbati V, Sullivan R, Yu J, Georgius P, Brooker CD, Siorek M, Ditterline B, Friedman JK, Russo MA. In-Clinic and At-Home Patient Experiences with Closed-Loop Spinal Cord Stimulation: 12-Month Outcomes from the Closed-Loop Australia Randomized Crossover Trial. Pain Ther. 2026 Jul 28. doi: 10.1007/s40122-026-00863-6. Online ahead of print.
PubMed 42518116
Mohabbati V, Sullivan R, Yu J, Georgius P, Brooker CD, Siorek M, McClelland NL, Coletti F, Sun X, Franke A, Russo MA. Early outcomes with a flexible ECAP based closed loop using multiplexed spinal cord stimulation waveforms-single-arm study with in-clinic randomized crossover testing. Pain Med. 2025 Nov 1;26(11):773-782. doi: 10.1093/pm/pnaf058.
PubMed 40378232

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 Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Long-term Patient Experience With a Medtronic Closed-Loop Spinal Cord Stimulation System
ClinicalTrials.gov ID: NCT05177354
Acronym / sponsor ID: MDT21017
Conditions: Low Back Pain, Leg Pain, Upper Limb Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 94 participants (actual)
Lead sponsor: MedtronicNeuroIndustry (pharma, biotech, devices)
Study start: 30 Nov 2021 (actual)
Primary completion: 4 May 2023 (actual)
Study completion: 28 Jul 2025 (actual)
First posted: 4 Jan 2022 (actual)
Results: Posted 2 Oct 2024

Clinical summary

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

The purpose of the study is to further understand the closed-loop feature in chronically implanted patients by characterizing the efficacy of the next generation, spinal cord stimulator.

Study design

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

Arm	Type	Receives
Treatment	Experimental	Device: Inceptiv

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
Candidate is undergoing Medtronic SCS device trial for chronic, intractable pain of the trunk and/or limbs
If being treated for low-back and/or leg pain,
If being treated for upper limb pain - baseline Visual Analog Scale is ≥ 60 mm for upper limb pain
On stable (no change in dose, route, or frequency) prescribed pain medications being used for back and leg pain or upper limb pain, as determined by the investigator, for at least 28 days prior to device trial

Key exclusion criteria (7 listed)

Indicated for an SCS device to treat stable intractable Angina Pectoris or Peripheral Vascular Disease of Fontaine Stage III or higher
Previously trialed or implanted with spinal cord stimulator, peripheral or vagus nerve stimulator, deep brain stimulator or an implantable intrathecal drug delivery system
Currently participating, or plans to participate, in another investigational study unless written approval is provided by the Medtronic study team
Major psychiatric comorbidity or other progressive diseases that may confound study results, as determined by the Investigator
Serious drug-related behavioral issues (e.g. alcohol dependency, illegal substance abuse), as determined by the Investigator

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
InceptivImplantable Neurostimulator with Neuro Sense	Device	Treatment

Primary outcome

Reduction in Overstimulation Sensation
Time frame: 30 days from device activation
The primary outcome is the proportion of low-back and/or leg pain subjects whose average overstimulation intensity score with Closed Loop On is less than their average overstimulation intensity score with Closed Loop Off. During in-clinic testing, subjects perform protocol prescribed activities and rate the intensity of the sensations on a 5-point Likert scale with both Closed Loop On and Off. The average overstimulation intensity scores within each subject are calculated separately for Closed Loop On and Off, and the proportion of subjects with a lower average overstimulation intensity score during Closed Loop On compared to their overstimulation intensity score during Closed Loop Off is calculated with a one-sided 97.5% lower bound.

3 secondary outcomes

Responder Rate for Treatment of Overall Pain
Time frame: 3 months from device activation
Responder Rate for Treatment of Low-back Pain
Time frame: 3 months from device activation
Responder Rate for Treatment of Leg Pain
Time frame: 3 months from device activation

Results and safety

Results posted to the registry on 2 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Implanted Subjects	60	57

Primary outcome: Reduction in Overstimulation Sensation

Time frame: 30 days from device activation. Count of participants. Unit: Participants

Measure	All Implanted Subjects n = 28
Value	25

All Implanted Subjects: Proportion: 89.3, p <0.001, Binomial Exact Test

Population analysed: The pre-specified Primary Analysis Set includes the first 28 low-back and/or leg pain subjects within the All Implanted Subjects Arm with clear and measurable Evoked Compound Action Potentials (ECAPs) who completed in-clinic testing at the 30-day visit. Of the 60 implanted subjects, 2 missed the 30-day visit, 55 completed the 30-day visit, 50 had low-back and/or leg pain and clear and measurable ECAPs, and the first 28 of these subjects are included in the analysis for this objective.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Implant through 3 months post activation. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Implanted Subjects	10 of 60 (16.7%)	3 of 60 (5%)	0 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42518116Mohabbati V, Sullivan R, Yu J, Georgius P, Brooker CD, Siorek M, Ditterline B, Friedman JK, Russo MA. In-Clinic and At-Home Patient Experiences with Closed-Loop Spinal Cord Stimulation: 12-Month Outcomes from the Closed-Loop Australia Randomized Crossover Trial. Pain Ther. 2026 Jul 28. doi: 10.1007/s40122-026-00863-6. Online ahead of print.
Derived from this study: PubMed 40378232Mohabbati V, Sullivan R, Yu J, Georgius P, Brooker CD, Siorek M, McClelland NL, Coletti F, Sun X, Franke A, Russo MA. Early outcomes with a flexible ECAP based closed loop using multiplexed spinal cord stimulation waveforms-single-arm study with in-clinic randomized crossover testing. Pain Med. 2025 Nov 1;26(11):773-782. doi: 10.1093/pm/pnaf058.
Individual participant dataSharing planned: No

Related trials for Low Back Pain

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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.

Marc Russo, MD principal investigator

Genesis Research Services

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

Questions about this trial

What is this clinical trial studying?

A study testing Inceptiv in people with Low Back Pain and Leg Pain, run by MedtronicNeuro at 7 sites in Australia.

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 7 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 5 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Australia. 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 2 Oct 2024). 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?

Reduction in Overstimulation Sensation (time frame: 30 days from device activation). 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 NCT05177354, which also lists 2 linked publications.

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 5 Nov 2025; AzTrials last refreshed its copy on 29 Oct 2026.