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Actively Recruiting
Optimization of VNS in Epileptic Patients to Induce Cardioprotection
About
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.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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
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Study Stats
Protocol No.
19-002279
Category
Brain/Neurological Diseases
Heart/Cardiovascular Diseases
Principal Investigator
Contact
Location
- UCLA Westwood