Optimization of VNS in Epileptic Patients to Induce Cardioprotection

October 5, 2023 updated by: Olujimi Ajijola, University of California, Los Angeles

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Olujimi Ajijola, MD, PhD

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
Time Frame: Following the 4 - week VNS treatment phase to the of the end of study.
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.
Time Frame: From pre VNS setting changes (baseline) to post VNS setting changes (end of study).
From pre VNS setting changes (baseline) to post VNS setting changes (end of study).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Olujimi Ajijola, MD, PhD, UCLA Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

June 30, 2023

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)

October 6, 2023

Last Update Submitted That Met QC Criteria

October 5, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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