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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pain, Intractable, Pain, Chronic

Intervention / Treatment
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* Device: Commercially available neurostimulation systems


Participation Criteria
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Eligibility Criteria
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Pilot Phase Inclusion Criteria: 18 years of age or older 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 Able to differentiate between pain associated with the indication for SCS implant and other types of pain, as determined by the Investigator or designee 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. Willing and able to provide signed and dated informed consent in English Willing and able to comply with all study procedures and visits Pilot Phase Exclusion Criteria: Any active implantable neuromodulation device or system (e.g., Peripheral Nerve Stimulation, Sacral Neuromodulation) 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 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 Serious drug-related behavioral issues (e.g., alcohol dependency, illegal substance abuse), as determined by the Investigator or designee Pregnant or planning on becoming pregnant Involved in an injury claim under current litigation, beneficiary of an injury claim, or receiving worker's compensation Patients with buried lead trials/implants will be excluded from this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pilot Phase Cohort<br> | Device: Commercially available neurostimulation systems<br>* Spinal cord stimulation therapy delivered during trialing and following implant of commercially available neurostimulation systems<br>|
| Data at Scale Phase Cohort<br> | Device: Commercially available neurostimulation systems<br>* Spinal cord stimulation therapy delivered during trialing and following implant of commercially available neurostimulation systems<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of surveys completed from Baseline through the SCS Trial Period in the Pilot Phase Cohort. | The percentage of surveys with complete data collected via the InsightPro™ clinical trial app from Baseline through the SCS Trial Period, calculated as the number of surveys with complete data divided by the total number of expected surveys within the Pilot Phase Cohort, expressed as a percentage. | Up to 28 days | 
| Rating on the 7-point scale of Patient Global Impression of Change (PGIC) at Month 3 in the Data at Scale Phase Cohort | PGIC is a single question asking the subject to rate their improvement in pain condition on a 7-point scale from 1 (Very Much Improved) to 7 (Very Much Worse) | Month 3 |