Open-loop testing, Closed-loop testing - External Spinal Cord Stimulator (SCS)
DeviceSCS therapy with an external neurostimulator using either open-loop or closed loop algorithm
NCT Number: NCT04765735
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.
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Notify Me22 year and older
All sexes
Interventional
Not applicable
Coastal Pain and Spinal Diagnostics, Carlsbad, California, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
SCS therapy with an external neurostimulator using either open-loop or closed loop algorithm
Time frame: In-clinic testing (1 day)
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.
MedtronicNeuro
Industry
Electrically Evoked Compound Action Potentials Human Observation Medtronic Algorithm Comparison Study (ECHO-MAC)
Acronym: ECHO-MAC
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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