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Medtronic Closed-Loop Spinal Cord Stimulation System | Clinical Trials | Clareo Health

COMPLETEDNA

Medtronic Closed-Loop Spinal Cord Stimulation System

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

NCT05177354•MedtronicNeuro

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (7)

Sydney Pain Specialists

Bella Vista, New South Wales, Australia

Genesis Research Services

Broadmeadow, New South Wales, Australia

Australian Medical Research

Hurstville, New South Wales, Australia

Royal North Shore Hospital

Saint Leonards, New South Wales, Australia

Sydney Pain Research Centre

Wahroonga, New South Wales, Australia

Sunshine Coast Clinical Research

Noosa, Queensland, Australia

Precision Brain Spine and Pain Center

Kew, Victoria, Australia

Key Dates

Start Date

November 30, 2021

Primary Completion Date

May 4, 2023

Completion Date

July 28, 2025

Last Updated

November 5, 2025

Enrollment

ACTUAL participants

Conditions

Low Back PainLeg PainUpper Limb Pain

Interventions

Inceptiv

DEVICE

Examination of Nociscan Impact on Discogenic Low Back Pain Surgical Outcomes

NCT06661850

Discogenic Low Back Pain

View study

RECRUITINGNA

Study of the Contribution of Osteopathic Treatment to Classic Medical Management in Patients With Chronic Low Back Pain

NCT03836248

Chronic Low Back Pain

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RECRUITING

Time to BBVNA Relief

NCT07433634

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Medtronic Closed-Loop Spinal Cord Stimulation System

Inclusion Criteria

Exclusion Criteria

Examination of Nociscan Impact on Discogenic Low Back Pain Surgical Outcomes

Study of the Contribution of Osteopathic Treatment to Classic Medical Management in Patients With Chronic Low Back Pain

Time to BBVNA Relief

MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion

The Effects of EXOPULSE Mollii Suit on Low Back Pain

The Effect of ESWT Added to Conservative Treatment on Pain, Disability, and Ultrasonographic Outcomes in Chronic Low Back Pain