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Medtronic Closed-Loop Spinal Cord Stimulation System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05177354
Recruitment Status : Recruiting
First Posted : January 4, 2022
Last Update Posted : August 2, 2022
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

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.

Condition or disease Intervention/treatment Phase
Low Back Pain Leg Pain Upper Limb Pain Device: Inceptiv Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Long-term Patient Experience With a Medtronic Closed-Loop Spinal Cord Stimulation System
Actual Study Start Date : November 30, 2021
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : March 31, 2025

Arm Intervention/treatment
Experimental: Treatment Device: Inceptiv
Implantable Neurostimulator with Neuro Sense




Primary Outcome Measures :
  1. Reduction in overstimulation sensation [ Time Frame: 30 days from device activation ]
    Comparison of Neuro Sense On vs Off at in-clinic testing for low-back and/or leg pain subjects. Subjects will perform protocol prescribed activities and rate the intensity of the sensation on a 5-point Likert scale. The average intensity scores during each period will be calculated for each subject. The proportion of low-back and leg pain subjects with a reduction in overstimulation sensation during Neuro Sense On compared to Neuro Sense Off will be calculated, with a one-sided 97.5% lower bound.


Secondary Outcome Measures :
  1. Responder rate for treatment of overall pain [ Time Frame: 3 months from device activation ]
    Low-back and/or leg pain subjects

  2. Responder rate for treatment of low-back pain [ Time Frame: 3 months from device activation ]
    Low-back pain subjects (baseline back VAS ≥60mm)

  3. Responder rate for treatment of leg pain [ Time Frame: 3 months from device activation ]
    Leg pain subjects (baseline leg VAS ≥60mm)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05177354


Contacts
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Contact: Garrett Grenier 1-800-MEDTRONIC garrett.grenier@medtronic.com

Locations
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Australia, New South Wales
Sydney Pain Specialists Recruiting
Bella Vista, New South Wales, Australia, 2153
Contact: Alan Nazha, MD         
Genesis Research Services Recruiting
Broadmeadow, New South Wales, Australia, 2292
Contact: Marc Russo, MD         
Australian Medical Research Recruiting
Hurstville, New South Wales, Australia, 2220
Contact: James Yu, MD         
Royal North Shore Hospital Recruiting
Saint Leonards, New South Wales, Australia, 2065
Contact: Charles Brooker, MD         
Sydney Pain Research Centre Recruiting
Wahroonga, New South Wales, Australia, 2076
Contact: Vahid Mohabbati, MD         
Australia, Victoria
Precision Brain Spine and Pain Center Recruiting
Kew, Victoria, Australia, 3101
Contact: Richard Sullivan, MD         
Sponsors and Collaborators
MedtronicNeuro
Investigators
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Principal Investigator: Marc Russo, MD Genesis Research Services
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Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT05177354    
Other Study ID Numbers: MDT21017
First Posted: January 4, 2022    Key Record Dates
Last Update Posted: August 2, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Low Back Pain
Back Pain
Pain
Neurologic Manifestations