Medtronic Closed-Loop Spinal Cord Stimulation System

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Leg Pain; Upper Limb Pain
• Intervention / Treatment: Device: Inceptiv

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment	Device: Inceptiv; Implantable Neurostimulator with Neuro Sense

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder Rate for Treatment of Overall Pain	Responder rate defined as a reduction in Overall (back/leg) pain VAS of at least 50%.	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%.	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%.	3 months from device activation

Collaborators and Investigators

• Sponsor: MedtronicNeuro
• Investigators: Principal Investigator: Marc Russo, MD, Genesis Research Services

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2021
• Primary Completion (Actual): May 4, 2023
• Study Completion (Actual): July 28, 2025

Study Registration Dates

• First Submitted: November 30, 2021
• First Submitted That Met QC Criteria: December 14, 2021
• First Posted (Actual): January 4, 2022

Study Record Updates

• Last Update Posted (Estimated): November 5, 2025
• Last Update Submitted That Met QC Criteria: October 31, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Low Back Pain
• Other Study ID Numbers: MDT21017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes