Study to Evaluate Neuromodulation Subject Experience With Contemporary Spinal Cord Stimulation (SCS) Modalities for Chronic Pain

Last updated: March 19, 2025
Sponsor: MedtronicNeuro
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Pain

Chronic Pain

Treatment

Commercially available neurostimulation systems

Clinical Study ID

NCT05775510
MDT22020
  • Ages > 18
  • All Genders

Study Summary

Medtronic, Inc. is sponsoring the SENSE SCS clinical study, a prospective, multi-center, post-market, non-randomized, observational study with a hybrid decentralized model of execution, utilizing a mobile application for the collection of patient reported outcomes (PROs). The purpose of the study is to evaluate workflow of a mobile application for collection of PROs and to gather data on patient experience with spinal cord stimulation therapy.

Eligibility Criteria

Inclusion

Pilot Phase Inclusion Criteria:

  1. 18 years of age or older

  2. A clinical decision was made for the patient to receive a commercial Medtronic SCSsystem (trial and implant) limited to the components for an on-label indicationprior to enrollment in the study. NOTE: Vectris™ SureScan™ MRI 1x8 subcompact andSpecify™SureScan™ MRI 2x8 leads are not eligible system components

  3. Able to differentiate between pain associated with the indication for SCS implantand other types of pain, as determined by the Investigator or designee

  4. Willing and able to use a personal smart phone for study surveys. NOTE: All subjectsparticipating in the study must be willing to download the InsightPro™ clinicaltrial app and maintain current software updates on their own smart phone.

  5. Willing and able to provide signed and dated informed consent in English

  6. Willing and able to comply with all study procedures and visits

Exclusion

Pilot Phase Exclusion Criteria:

  1. Any active implantable neuromodulation device or system (e.g., Peripheral NerveStimulation, Sacral Neuromodulation)

  2. Currently participating, or plans to participate, in another investigational studyor has a planned major medical procedure that may interfere with study procedures orconfound study results, as determined by the Investigator or designee, unlessdocumented pre-approval is provided by the sponsor

  3. Major untreated or refractory psychiatric comorbidity or other progressive disease (e.g., neurodegenerative disease, heart failure, cancer) that may confound studyresults, as determined by the Investigator or designee

  4. Serious drug-related behavioral issues (e.g., alcohol dependency, illegal substanceabuse), as determined by the Investigator or designee

  5. Pregnant or planning on becoming pregnant

  6. Involved in an injury claim under current litigation, beneficiary of an injuryclaim, or receiving worker's compensation

  7. Patients with buried lead trials/implants will be excluded from this study

Study Design

Total Participants: 1650
Treatment Group(s): 1
Primary Treatment: Commercially available neurostimulation systems
Phase:
Study Start date:
March 30, 2023
Estimated Completion Date:
March 31, 2026

Connect with a study center

  • Coastal Research Institute

    Carlsbad, California 92009
    United States

    Site Not Available

  • Pain Management Consultants of Southwest Florida

    Fort Myers, Florida 33907
    United States

    Site Not Available

  • Twin Cities Pain Clinic

    Edina, Minnesota 55439
    United States

    Site Not Available

  • Garden State Pain and Orthopedics

    Clifton, New Jersey 07013
    United States

    Site Not Available

  • Novant Health Spine Specialists

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Oklahoma Pain Management

    Oklahoma City, Oklahoma 73134
    United States

    Site Not Available

  • Pain Diagnostics and Interventional Care

    Sewickley, Pennsylvania 15143
    United States

    Site Not Available

  • North Texas Orthopedics and Spine Center

    Grapevine, Texas 76051
    United States

    Site Not Available

  • The San Antonio Orthopaedic Group

    San Antonio, Texas 78235
    United States

    Site Not Available

  • Procura Pain and Spine PLLC

    Shenandoah, Texas 77384
    United States

    Site Not Available

  • Sprintz Center for Pain

    Shenandoah, Texas 77384
    United States

    Active - Recruiting

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