Mode
Home
Research
Clinical Trials Drug Pipeline Weekly Digests
Reference
Conditions Medications
Community
Questions
Text Size
Log in / Sign up
N/A Completed N=1 Treatment

Optimization of VNS in Epileptic Patients to Induce Cardioprotection

Epilepsy · Sudden Cardiac Death
Source: ClinicalTrials.gov NCT04387435 ↗
Enrolled (actual)
1
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcomePrimary: Change in Seizure Frequency or Duration Via a Routine Seizure History Used in Clinical Practice.

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Seizure Frequency or Duration Via a Routine Seizure History Used in Clinical Practice.		 — —
SECONDARY
Change in Heart Rate and Blood Pressure in Response to Upright Tilt, Deep Breathing, Valsalva Maneuver and a Cold Pressor Test.		 — —

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04387435). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

Back to search