Clinical trial NCT04387435: Optimization of VNS in Epileptic Patients to Induce Cardioprotection
Official title: A Feasibility Study to Evaluate the Safety and Effect of the Optimization of Vagus Nerve Stimulation in Epileptic Patients to Induce Cardioprotection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Sudden Cardiac Death
Keywords: Vagus Nerve Stimulation (VNS)
Neuromodulation
Autonomics
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2020-05-13
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: Epilepsy patients are at increased risk for sudden cardiac death. Mechanisms behind this predisposition is poorly understood but parasympathetic dysfunction is heavily implicated. Vagus Nerve Stimulation (VNS) protocols currently set for seizure management are poorly optimized for cardioprotection, therefore this patient population presents a unique opportunity to assess VNS control of cardiac function, when VNS is appropriately titrated for cardiac and seizure benefit.

This study will enroll 12 patients with a diagnosis of epilepsy and previously implanted FDA approved VNS devices. The study will last up to 9 weeks and the patient will undergo changes to their VNS settings during autonomic testing and cardiopulmonary testing.

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

Primary outcomes:
measure: 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.
Secondary outcomes:
measure: Change in Heart Rate and Blood Pressure in Response to Upright Tilt, Deep Breathing, Valsalva Maneuver and a Cold Pressor Test.
timeFrame: From pre VNS setting changes (baseline) to post VNS setting changes (end of study).
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Health
state: California
Study officials:
affiliation: UCLA Health
name: Olujimi Ajijola, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: