Optimization of VNS in Epileptic Patients to Induce Cardioprotection

A Feasibility Study to Evaluate the Safety and Effect of the Optimization of Vagus Nerve Stimulation in Epileptic Patients to Induce Cardioprotection

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy; Sudden Cardiac Death
• Intervention / Treatment: Other: A change or titration in the current or frequency settings of the VNS therapy system.

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 Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; Single arm	Other: A change or titration in the current or frequency settings of the VNS therapy system.; The study treatment involves changing the output current or frequency of the default device settings in a FDA approved device for VNS therapy. The proposed frequency changes in this study are within the FDA approved output current and frequency levels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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).

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Olujimi Ajijola, MD, PhD, UCLA Health

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): July 7, 2021
• Study Completion (Actual): July 7, 2021

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 12, 2020
• First Posted (Actual): May 13, 2020

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: March 22, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Neuromodulation; Vagus Nerve Stimulation (VNS); Autonomics
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Heart Arrest; Death, Sudden; Death, Sudden, Cardiac; Death
• Other Study ID Numbers: 19-002279; OT2OD028201 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes