Optimization of VNS in Epileptic Patients to Induce Cardioprotection

Not Applicable

Completed

• Conditions: Epilepsy; Sudden Cardiac Death
• Interventions: Other: A change or titration in the current or frequency settings of the VNS therapy system.

• Registration Number: NCT04387435
• Lead Sponsor: University of California, Los Angeles

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.

Study Timeline

• Study First Submitted: 2020-05-04
• Study First Submitted QC: 2020-05-12
• Study First Posted: 2020-05-13
• Study Start: 2020-12-01
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30
• Status Verified: 2024-08
• Results First Submitted: 2024-08-02
• Results First Submitted QC: 2024-08-02
• Last Update Submitted: 2024-08-02
• Results First Posted: 2024-08-28
• Last Update Posted: 2024-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Arm	A change or titration in the current or frequency settings of the VNS therapy system.	Single arm

Primary Outcome Measures

Name	Time	Method
Change in Seizure Frequency or Duration Via a Routine Seizure History Used in Clinical Practice.	Following the 4 - week VNS treatment phase to the of the end of study.

Secondary Outcome Measures

Name	Time	Method
Change in Heart Rate and Blood Pressure in Response to Upright Tilt, Deep Breathing, Valsalva Maneuver and a Cold Pressor Test.	From pre VNS setting changes (baseline) to post VNS setting changes (end of study).

Trial Locations

Locations (1)

UCLA Health; 🇺🇸 Los Angeles, California, United States