This is a prospective, multi-center, non-significant risk IDE study of evoked waveforms resulting from stimulation of the dorsal column using a closed-loop system. comprised of Medtronic hardware or off the shelf hardware, which uses recorded waveforms to adjust stimulation amplitude.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
201
Spinal Cord Stimulation (SCS) as an aid in the management of chronic, intractable pain of the trunk and/or limbs.
Coastal Pain and Spinal Diagnostics
Carlsbad, California, United States
MercyOne Des Moines Medical Center
Des Moines, Iowa, United States
Nura Research Institute
Edina, Minnesota, United States
Collection of ECAP data (sensing configurations, stimulation parameters eliciting ECAPs, control policies/algorithms for recording ECAPs) via the research system.
The ECAP data collected is prototype system/device information for development of a closed loop system.
Time frame: 1 hour to 72 hours
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Twin Cities Pain Clinic
Edina, Minnesota, United States
iSpine Pain Physicians
Maple Grove, Minnesota, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Kettering Health
Kettering, Ohio, United States
Premier Pain Treatment Institute
Mount Orab, Ohio, United States
Center for Interventional Pain and Spine
Lancaster, Pennsylvania, United States
Rockefeller Neuroscience Institute West Virginia University
Morgantown, West Virginia, United States