This is a prospective, multi-center, randomized, single-blind, cross-over, non-significant risk IDE research study to evaluate the in-clinic performance of a closed-loop algorithm in Spinal Cord Stimulation (SCS) therapy with an ENS device.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
52
SCS therapy with an external neurostimulator using either open-loop or closed loop algorithm
Coastal Pain and Spinal Diagnostics
Carlsbad, California, United States
Lakewalk Surgery Center
Duluth, Minnesota, United States
Nura Research Institute
Edina, Minnesota, United States
Twin Cities Pain Clinic
The Proportion of Subjects With a Reduction in Overstimulation Sensation With SCS Using a Closed-loop Algorithm Compared With SCS in Open-loop
For every overstimulation sensation brought about by protocol-prescribed activities, subjects will rate the intensity of the sensation using a 5-point Likert scale. The average intensity score during OL and CL periods will be calculated for each subject. If the average intensity score during CL period is less than that from the OL period, the subject is considered as a subject with a reduction in overstimulation sensation during CL vs. OL period. The primary endpoint is the proportion of subjects with a reduction in overstimulation sensation among subjects who have in-clinic testing.
Time frame: In-clinic testing (1 day)
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Edina, Minnesota, United States
The Ohio State University
Columbus, Ohio, United States
Kettering Medical Center
Kettering, Ohio, United States
Premier Pain Treatment Institute
Mount Orab, Ohio, United States
Center for Interventional Pain and Spine
Lancaster, Pennsylvania, United States
Innovative Pain Center
Watertown, South Dakota, United States