Optimization of VNS in Epileptic Patients to Induce Cardioprotection

NCT ID: NCT04387435

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2021-07-07

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.

Conditions

Epilepsy; Sudden Cardiac Death

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Arm

Single arm

Group Type: EXPERIMENTAL

A change or titration in the current or frequency settings of the VNS therapy system.

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Olujimi Ajijola

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Olujimi Ajijola, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UCLA Health

Locations

UCLA Health

Los Angeles, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

OT2OD028201

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-002279

Identifier Type: -

Identifier Source: org_study_id