Status:
COMPLETED
Optimization of VNS in Epileptic Patients to Induce Cardioprotection
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Epilepsy
Sudden Cardiac Death
Eligibility:
All Genders
18+ years
Phase:
NA
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 invest...
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 Stimulat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2021
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04387435
Start Date
December 1 2020
End Date
July 7 2021
Last Update
April 6 2025
Active Locations (1)
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1
UCLA Health
Los Angeles, California, United States, 90095