N/A N=1 Treatment

Optimization of VNS in Epileptic Patients to Induce Cardioprotection

Epilepsy · Sudden Cardiac Death

Bottom Line

View on ClinicalTrials.gov: NCT04387435 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2024

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

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: A change or titration in the current or frequency settings of the VNS therapy system. (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of California, Los Angeles
Primary completion: Jul 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Seizure Frequency or Duration Via a Routine Seizure History Used in Clinical Practice.	—	—
SECONDARY Change in Heart Rate and Blood Pressure in Response to Upright Tilt, Deep Breathing, Valsalva Maneuver and a Cold Pressor Test.	—	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04387435). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.