Optimization of VNS in Epileptic Patients to Induce Cardioprotection

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04387435
• Other study ID #: 19-002279
• Secondary ID: OT2OD028201
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: June 30, 2023

Study information

• Verified date: October 2023
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Death
• Death, Sudden, Cardiac
• Epilepsy
• Sudden Cardiac Death

Intervention

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.

Locations

Country	Name	City	State
United States	UCLA Health	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).