CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1 enrolled
Drug / intervention
A change or titration in the current or frequency settings of the VNS therapy system.other
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04387435
NCT04387435N/ACompleted
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A Feasibility Study to Evaluate the Safety and Effect of the Optimization of Vagus Nerve Stimulation in Epileptic Patients to Induce Cardioprotection

University of California, Los Angeles·interventional·Posted May 13, 2020·Updated Apr 6, 2025

In Brief

A clinical study evaluating A change or titration in the current or frequency settings of the VNS therapy system. for Epilepsy and Sudden Cardiac Death. Completed, enrolled 1 participant across 1 site.

Detailed Summary

This study is a non-randomized, prospective study in patients with a diagnosis of epilepsy and previously implanted FDA approved Vagus Nerve Stimulation (VNS) devices. The goal of this clinical investigation is to evaluate the effects of adjusting vagus nerve stimulation parameters to engage cardioprotective effects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEpilepsy, Sudden Cardiac Death
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH)

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMay 13, 2020
Enrollment StartDec 1, 2020
Primary CompletionJul 7, 2021
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 6.1 years ago

Interventions

A change or titration in the current or frequency settings of the VNS therapy system.other

The study treatment involves changing the output current or frequency of the default device settings in a FDA approved device for VNS therapy. The proposed frequency changes in this study are within the FDA approved output current and frequency levels.