Clinical trial NCT05775510: Study to Evaluate Neuromodulation Subject Experience With Contemporary Spinal Cord Stimulation (SCS) Modalities for Chronic Pain
Official title: Study to Evaluate Neuromodulation Subject Experience With Contemporary Spinal Cord Stimulation (SCS) Modalities for Chronic Pain (SENSE SCS Clinical Study)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pain, Intractable
Pain, Chronic
Lead sponsor: MedtronicNeuro
Sponsor class: INDUSTRY
First posted: 2023-03-20
Enrollment: 1650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The intended study population is adults with chronic, intractable pain of the trunk and/or limbs indicated to receive a Medtronic SCS system. Study eligibility criteria must be met to participate in this study.

Brief 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: 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

Primary outcomes:
measure: Percentage of surveys completed from Baseline through the SCS Trial Period in the Pilot Phase Cohort.
timeFrame: Up to 28 days
measure: Rating on the 7-point scale of Patient Global Impression of Change (PGIC) at Month 3 in the Data at Scale Phase Cohort
timeFrame: Month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Carlsbad
country: United States
facility: Coastal Research Institute
state: California
city: Fort Myers
country: United States
facility: Pain Management Consultants of Southwest Florida
state: Florida
city: Edina
country: United States
facility: Twin Cities Pain Clinic
state: Minnesota
city: Clifton
country: United States
facility: Garden State Pain and Orthopedics
state: New Jersey
city: Winston-Salem
country: United States
facility: Novant Health Spine Specialists
state: North Carolina
city: Oklahoma City
country: United States
facility: Oklahoma Pain Management
state: Oklahoma
city: Sewickley
country: United States
facility: Pain Diagnostics and Interventional Care
state: Pennsylvania
city: Grapevine
country: United States
facility: North Texas Orthopedics and Spine Center
state: Texas
city: San Antonio
country: United States
facility: The San Antonio Orthopaedic Group
state: Texas
city: Shenandoah
country: United States
facility: Procura Pain and Spine PLLC
state: Texas
Study officials:
affiliation: Medtronic
name: Mirit Argov
role: STUDY_DIRECTOR
References: