A Feasibility Study to Evaluate the Safety and Effect of the Optimization of Vagus Nerve Stimulation in Epileptic Patients to Induce Cardioprotection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Change in Seizure Frequency or Duration Via a Routine Seizure History Used in Clinical Practice.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Seizure Frequency or Duration Via a Routine Seizure History Used in Clinical Practice.
时间窗: Following the 4 - week VNS treatment phase to the of the end of study.
次要结局
- Change in Heart Rate and Blood Pressure in Response to Upright Tilt, Deep Breathing, Valsalva Maneuver and a Cold Pressor Test.(From pre VNS setting changes (baseline) to post VNS setting changes (end of study).)
研究者
Olujimi Ajijola
MD, PhD
University of California, Los Angeles