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Optimization of VNS in Epileptic Patients to Induce Cardioprotection

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ClinicalTrials.gov Identifier: NCT04387435
Recruitment Status : Recruiting
First Posted : May 13, 2020
Last Update Posted : October 1, 2021
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Inna Keselman, 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.

Condition or disease Intervention/treatment Phase
Epilepsy Sudden Cardiac Death Other: A change or titration in the current or frequency settings of the VNS therapy system. Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility Study to Evaluate the Safety and Effect of the Optimization of Vagus Nerve Stimulation in Epileptic Patients to Induce Cardioprotection
Actual Study Start Date : December 1, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy


Intervention Details:
  • 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.


Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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). ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04387435


Contacts
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Contact: Julie M Sorg, MSN 310-206-2235 jsorg@mednet.ucla.edu
Contact: Olujimi Ajijola, MD, PhD

Locations
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United States, California
UCLA Health Recruiting
Los Angeles, California, United States, 90095
Contact: Inna Keselman, MD, PhD         
Sub-Investigator: Olujimi Ajijola, MD, PhD         
Sub-Investigator: Jeffrey Ardell, PhD         
Sub-Investigator: Jason Bradfield, MD         
Sub-Investigator: Kalyanam Shivkumar, MD, PhD         
Sub-Investigator: Marmar Vaseghi, MD, PhD         
Sponsors and Collaborators
University of California, Los Angeles
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Inna Keselman, MD, PhD University of California, Los Angeles
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Responsible Party: Inna Keselman, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04387435    
Other Study ID Numbers: 19-002279
OT2OD028201 ( U.S. NIH Grant/Contract )
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: October 1, 2021
Last Verified: September 2021

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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
Keywords provided by Inna Keselman, University of California, Los Angeles:
Vagus Nerve Stimulation (VNS)
Neuromodulation
Autonomics
Additional relevant MeSH terms:
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Death, Sudden, Cardiac
Death
Pathologic Processes
Heart Arrest
Heart Diseases
Cardiovascular Diseases
Death, Sudden