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

Description

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.

Conditions

Pain, Intractable, Pain, Chronic

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Pain, Intractable
Intervention / Treatment

-

Contacts and Locations

Carlsbad

Coastal Research Institute, Carlsbad, California, United States, 92009

Fort Myers

Pain Management Consultants of Southwest Florida, Fort Myers, Florida, United States, 33907

Edina

Twin Cities Pain Clinic, Edina, Minnesota, United States, 55439

Clifton

Garden State Pain and Orthopedics, Clifton, New Jersey, United States, 07013

Winston-Salem

Novant Health Spine Specialists, Winston-Salem, North Carolina, United States, 27103

Oklahoma City

Oklahoma Pain Management, Oklahoma City, Oklahoma, United States, 73134

Sewickley

Pain Diagnostics and Interventional Care, Sewickley, Pennsylvania, United States, 15143

Grapevine

North Texas Orthopedics and Spine Center, Grapevine, Texas, United States, 76051

San Antonio

The San Antonio Orthopaedic Group, San Antonio, Texas, United States, 78235

Shenandoah

Procura Pain and Spine PLLC, Shenandoah, Texas, United States, 77384

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. 18 years of age or older
  • 2. A clinical decision was made for the patient to receive a commercial Medtronic SCS system (trial and implant) limited to the components for an on-label indication prior to enrollment in the study. NOTE: Vectris™ SureScan™ MRI 1x8 subcompact and Specify™SureScan™ MRI 2x8 leads are not eligible system components
  • 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
  • 7. Patients with buried lead trials/implants will be excluded from this study

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

MedtronicNeuro,

Mirit Argov, STUDY_DIRECTOR, Medtronic

Study Record Dates

2026-03