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

Medtronic

Status: Active, not recruiting

Conditions: Pain, Intractable; Pain, Chronic

Treatments: Device: Commercially available neurostimulation systems

Study type: Observational

Funder types: Industry

Identifiers

NCT05775510

MDT22020

Details and patient eligibility

About

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.

Enrollment: 1,650 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 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

Pilot Phase Exclusion Criteria:

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

Trial design

1,650 participants in 2 patient groups

Pilot Phase Cohort

Treatment:

Device: Commercially available neurostimulation systems

Data at Scale Phase Cohort

Treatment:

Device: Commercially available neurostimulation systems