CompletedNot Applicable

Optimization of VNS in Epileptic Patients to Induce Cardioprotection

United States1 participantsStarted 2020-12-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

What they're measuring

Change in Seizure Frequency or Duration Via a Routine Seizure History Used in Clinical Practice.

Timeframe: Following the 4 - week VNS treatment phase to the of the end of study.

Trial details

NCT IDNCT04387435

SponsorUniversity of California, Los Angeles

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-07-07

Results submitted2024-08-02

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