Optimization of VNS in Epileptic Patients to Induce Cardioprotection
Primary Purpose
Epilepsy, Sudden Cardiac Death
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
A change or titration in the current or frequency settings of the VNS therapy system.
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Vagus Nerve Stimulation (VNS), Neuromodulation, Autonomics
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
Sites / Locations
- UCLA Health
Outcomes
Primary Outcome Measures
Change in seizure frequency or duration via a routine seizure history used in clinical practice.
Secondary Outcome Measures
Change in heart rate and blood pressure in response to upright tilt, deep breathing, Valsalva maneuver and a cold pressor test.
Full Information
NCT ID
NCT04387435
First Posted
May 4, 2020
Last Updated
October 5, 2023
Sponsor
University of California, Los Angeles
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT04387435
Brief Title
Optimization of VNS in Epileptic Patients to Induce Cardioprotection
Official Title
A Feasibility Study to Evaluate the Safety and Effect of the Optimization of Vagus Nerve Stimulation in Epileptic Patients to Induce Cardioprotection
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
National Institutes of Health (NIH)
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Sudden Cardiac Death
Keywords
Vagus Nerve Stimulation (VNS), Neuromodulation, Autonomics
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
A change or titration in the current or frequency settings of the VNS therapy system.
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
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).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olujimi Ajijola, MD, PhD
Organizational Affiliation
UCLA Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Health
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Optimization of VNS in Epileptic Patients to Induce Cardioprotection
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