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Study to Evaluate Neuromodulation Subject Experience With Contemporary Spinal Cord Stimulation (SCS) Modalities for Chronic Pain | Clinical Trials | Clareo Health

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

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

NCT05775510•MedtronicNeuro

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 18 years of age or older

Exclusion Criteria

•3. Able to differentiate between pain associated with the indication for SCS implant and 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 subjects participating in the study must be willing to download the InsightPro™ clinical trial 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
•1. Any active implantable neuromodulation device or system (e.g., Peripheral Nerve Stimulation, Sacral Neuromodulation)
•2. Currently participating, or plans to participate, in another investigational study or has a planned major medical procedure that may interfere with study procedures or confound study results, as determined by the Investigator or designee, unless documented 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 study results, as determined by the Investigator or designee
•4. Serious drug-related behavioral issues (e.g., alcohol dependency, illegal substance abuse), 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 injury claim, or receiving worker's compensation
+1 more criteria

Locations (10)

Coastal Research Institute

Carlsbad, California, United States

Pain Management Consultants of Southwest Florida

Fort Myers, Florida, United States

Twin Cities Pain Clinic

Edina, Minnesota, United States

Garden State Pain and Orthopedics

Clifton, New Jersey, United States

Novant Health Spine Specialists

Winston-Salem, North Carolina, United States

Oklahoma Pain Management

Oklahoma City, Oklahoma, United States

Pain Diagnostics and Interventional Care

Sewickley, Pennsylvania, United States

North Texas Orthopedics and Spine Center

Grapevine, Texas, United States

The San Antonio Orthopaedic Group

San Antonio, Texas, United States

Procura Pain and Spine PLLC

Shenandoah, Texas, United States

Key Dates

Start Date

April 25, 2023

Primary Completion Date

May 29, 2025

Completion Date

May 29, 2025

Last Updated

January 14, 2026

Enrollment

ACTUAL participants

Conditions

Pain, IntractablePain, Chronic

Interventions

Commercially available neurostimulation systems

DEVICE

Nutrition Care in Patients Living With Chronic Pain

NCT06277232

Nutrition PoorOverweight and Obesity+2 more

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RECRUITINGPHASE2

Prescription Opioids, Brain Structure, and Cognition in Older Adults With Chronic Pain

NCT06837857

Pain, Chronic

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RECRUITING

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: January 14, 2026Data 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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Study to Evaluate Neuromodulation Subject Experience With Contemporary Spinal Cord Stimulation (SCS) Modalities for Chronic Pain

Inclusion Criteria

Exclusion Criteria

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