Phase
Condition
Pain
Chronic Pain
Treatment
Commercially available neurostimulation systems
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Pilot Phase Inclusion Criteria:
18 years of age or older
A clinical decision was made for the patient to receive a commercial Medtronic SCSsystem (trial and implant) limited to the components for an on-label indicationprior to enrollment in the study. NOTE: Vectris™ SureScan™ MRI 1x8 subcompact andSpecify™SureScan™ MRI 2x8 leads are not eligible system components
Able to differentiate between pain associated with the indication for SCS implantand 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 subjectsparticipating in the study must be willing to download the InsightPro™ clinicaltrial 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
Exclusion
Pilot Phase Exclusion Criteria:
Any active implantable neuromodulation device or system (e.g., Peripheral NerveStimulation, Sacral Neuromodulation)
Currently participating, or plans to participate, in another investigational studyor has a planned major medical procedure that may interfere with study procedures orconfound study results, as determined by the Investigator or designee, unlessdocumented 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 studyresults, as determined by the Investigator or designee
Serious drug-related behavioral issues (e.g., alcohol dependency, illegal substanceabuse), as determined by the Investigator or designee
Pregnant or planning on becoming pregnant
Involved in an injury claim under current litigation, beneficiary of an injuryclaim, or receiving worker's compensation
Patients with buried lead trials/implants will be excluded from this study
Study Design
Connect with a study center
Coastal Research Institute
Carlsbad, California 92009
United StatesSite Not Available
Pain Management Consultants of Southwest Florida
Fort Myers, Florida 33907
United StatesSite Not Available
Twin Cities Pain Clinic
Edina, Minnesota 55439
United StatesSite Not Available
Garden State Pain and Orthopedics
Clifton, New Jersey 07013
United StatesSite Not Available
Novant Health Spine Specialists
Winston-Salem, North Carolina 27103
United StatesSite Not Available
Oklahoma Pain Management
Oklahoma City, Oklahoma 73134
United StatesSite Not Available
Pain Diagnostics and Interventional Care
Sewickley, Pennsylvania 15143
United StatesSite Not Available
North Texas Orthopedics and Spine Center
Grapevine, Texas 76051
United StatesSite Not Available
The San Antonio Orthopaedic Group
San Antonio, Texas 78235
United StatesSite Not Available
Procura Pain and Spine PLLC
Shenandoah, Texas 77384
United StatesSite Not Available
Sprintz Center for Pain
Shenandoah, Texas 77384
United StatesActive - Recruiting
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