Electrically Evoked Compound Action Potentials Human Observation Medtronic Algorithm Comparison Study
CompletedNAResults postedLast updated 26 February 2024
What this trial tests
NA trial testing Open-loop testing, Closed-loop testing - External Spinal Cord Stimulator (SCS) in Chronic Pain in 52 participants. Completed in 29 June 2021.
22 and older, any sex, with Chronic Pain. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The Proportion of Subjects With a Reduction in Overstimulation Sensation With SCS Using a Closed-loop Algorithm Compared With SCS in Open-loopPrimary· 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.
Group
Value
95% CI
Intent-to-treat (ITT)
41
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by MedtronicNeuro
Last refreshed: 26 February 2024
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