Optimization of VNS in Epileptic Patients to Induce Cardioprotection

Completed · Not applicable

Conditions studied: Epilepsy, Sudden Cardiac Death

In brief

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.

Key facts

Study ID

NCT04387435

Run by

University of California, Los Angeles

People needed

1

Starts

2020-12-01

Expected to finish

2021-07-07

Last updated by the study team

2025-04-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of refractory epilepsy and implanted with a VNS device or are scheduled to be implanted with a VNS device.
• 18 years of age or older
• Subjects must demonstrate willingness and ability to comply with study requirements

You may not qualify if…

• Other implantable neuromodulatory device (e.g., brain stimulator)
• Treatment with cholinergic or anticholinergic medication in the past month
• Pre-existing cardiac arrhythmia or presence of cardiac pacemaker/defibrillator
• History of dysautonomias
• History of vasovagal syncope
• Progressive neurological diseases other than epilepsy
• Women that are pregnant
• Cognitive or psychiatric deficit that in the investigator's judgment would interfere with the subject's ability to accurately complete study assessments

Where it is running

• UCLA Health — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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