Medtronic Closed-Loop Spinal Cord Stimulation System

NCT05177354 | Completed Results FDA Device

• 1 other identifier: MDT21017
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Low Back Pain; Leg Pain; Upper Limb Pain

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days from device activation

Secondary Outcomes (3)

• Responder Rate for Treatment of Overall Pain

  3 months from device activation

• Responder Rate for Treatment of Low-back Pain

  3 months from device activation

• Responder Rate for Treatment of Leg Pain

  3 months from device activation

Study Arms (1)

Treatment

EXPERIMENTAL

Device: Inceptiv

Interventions

Inceptiv DEVICE

Implantable Neurostimulator with Neuro Sense

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MedtronicNeuro: lead

Study Sites (7)

Sydney Pain Specialists

Bella Vista, New South Wales, 2153, Australia

Location

Genesis Research Services

Broadmeadow, New South Wales, 2292, Australia

Location

Australian Medical Research

Hurstville, New South Wales, 2220, Australia

Location

Royal North Shore Hospital

Saint Leonards, New South Wales, 2065, Australia

Location

Sydney Pain Research Centre

Wahroonga, New South Wales, 2076, Australia

Location

Sunshine Coast Clinical Research

Noosa, Queensland, 4567, Australia

Location

Precision Brain Spine and Pain Center

Kew, Victoria, 3101, Australia

Location

Related Publications (1)

• 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.

  PMID: 40378232 DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Nancy McClelland
• Organization: Medtronic Neuromodulation

nancy.l.mcclelland@medtronic.com

1-800-633-8766

Study Officials

• Marc Russo, MD

  Genesis Research Services

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: January 4, 2022
• Study Start: November 30, 2021
• Primary Completion: May 4, 2023
• Study Completion: July 28, 2025
• Last Updated: November 5, 2025
• Results First Posted: October 2, 2024

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (7)