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NCT04765735: ECHO-MAC

Electrically Evoked Compound Action Potentials Human Observation Medtronic Algorithm Comparison Study

Completed NA Results posted Last 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.

Timeline
23 February 2021
Primary endpoint
29 June 2021
29 June 2021

Quick facts

Lead sponsorMedtronicNeuro
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingsingle
Primary purposetreatment
Enrollment52
Start date23 February 2021
Primary completion29 June 2021
Estimated completion29 June 2021
Sites9 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

MedtronicNeuro — full company profile →

Who can join

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-loop Primary · 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.

GroupValue95% 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):

  1. Closed-Loop Spinal Cord Stimulation in Chronic Pain Management: Mechanisms, Clinical Evidence, and Emerging Perspectives.
    Mangano N, Torpey A, Devitt C, Wen GA, et al · · 2025 · cited 5× · PMID 40426918 · DOI 10.3390/biomedicines13051091

Verify or expand the search:

Other recruiting trials for Chronic Pain

Currently open trials in the same condition.

Other MedtronicNeuro trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04765735.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing