Effect of Electrical Stimulation of the Auricular Branch of the Vagus Nerve (ABVN) on Cervical Vagus Nerve Action Potentials Phase 2 - VNS Seizure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Measure changes in chest diameter resulting from breathing
研究概览
简要总结
The purpose of this study is to find out if manual stimulation of the vagus nerve is possible. The vagus nerve is a largely-internal nerve that controls many bodily functions, including stomach function. The hope is that electrically stimulating the nerve around the external ear will also stimulate the internal vagus nerve.
详细描述
The purpose of this study is to find out if it is possible to gain access to the vagus nerve which is largely an internal nerve that controls stomach function. The hope is to gain access to the internal vagus nerve by electrically stimulating the nerve around the external ear. If this is possible to do this then there is hope that this will help the treatment of patients with nausea and vomiting and disordered stomach function. Healthy subjects and subjects with gastroparesis will be recruited. Subjects will undergo transcutaneous stimulation of the auricular branch of the vagus nerve and also undergo blood draw before, after stimulation and later a third draw after a period of no stimulation. Healthy subjects will also undergo vagal maneuver using the Multi Array Electrodes (MEA). Subjects will also complete health history questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteers with no GI symptoms
- •Ages 18-80
- •Undergoing VNS Therapy as part of clinical treatment for focal or partial epilepsy or seizure
- •Willing to have MEA electrodes placed on the neck and bipolar electrodes placed on chest and stomach
排除标准
- •Unable to provide consent
- •Having gastric motility issues (not due to COVID 19) as determined by the PI or Sub I
- •Taking medications affecting gastric motility
- •Pregnant females
- •Prisoners
结局指标
主要结局
Measure changes in chest diameter resulting from breathing
时间窗: 3 hours
To measure and evaluate respiratory variation of heart rate.
Amplitude surface electrogastrogram
时间窗: 3 hours
To measure changes in the amplitude of the surface electrogastrogram during ABVN and also during the vagal maneuvers phase.
Vagal Nerve Activation
时间窗: 3 hours
To measure the amplitude of vagal nerve compound action potentials in gastroparetic subjects with symptoms of nausea and vomiting with skin electrodes over right and left vagus nerve during ABVN stimulation and also during the vagal maneuvers phase
Heart rate variability
时间窗: 3 hours
To measure the Heart rate variability(HRV), vagal nerve compound action potentials and electrogastrogram in subjects undergoing VNS Therapy for focal or partial seizures.
次要结局
未报告次要终点
研究者
Thomas V. Nowak
Professor of Clinical Medicine
Indiana University