Open 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
Treatment
Study Type
Interventional
Phase
N/A

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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

Join this Trial

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Study Stats
Protocol No.
19-002279
Category
Neurosurgery
Contact
Julie Sorg
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04387435
For detailed technical eligibility, visit ClinicalTrials.gov.