Medtronic Closed-Loop Spinal Cord Stimulation System

NCT ID: NCT05177354

Last Updated: 2025-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-30
• Study Completion Date: 2025-07-28

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Group Type: EXPERIMENTAL

Inceptiv

Intervention Type: DEVICE

Implantable Neurostimulator with Neuro Sense

Interventions

Inceptiv

Implantable Neurostimulator with Neuro Sense

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MedtronicNeuro

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Russo, MD

Role: PRINCIPAL_INVESTIGATOR

Genesis Research Services

Locations

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

Countries

Australia

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MDT21017

Identifier Type: -

Identifier Source: org_study_id