Effect of Electrical Stimulation of the Auricular Branch of the Vagus Nerve (ABVN) on Cervical Vagus Nerve Action Potentials Phase 2
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- Respiratory Changes in heart rate during stimulation
研究概览
简要总结
The purpose of this study is to find out if we can gain access to the vagus nerve which is largely an internal nerve that controls stomach function. We hope to gain access to the internal vagus nerve by electrically stimulating the nerve around the external ear. If we can do this then we hope that this will help our treatment of patients with nausea and vomiting and disordered stomach function
详细描述
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). Gastroparetic subjects will also undergo vagal maneuver using either the regular EKG electrodes or the MEA electrodes.
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
- Parallel
- 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
- 是
入选标准
- •healthy volunteers
- •Healthy volunteers with no gastric symptoms or conditions (except due to COVID 19)
- •Aged 18-80 years
- •Willing to have electrodes placed in the external ear (ABVN arm)
- •Willing to perform vagal activity maneuver (Vagal arm)
- •Willing to have 1 tablespoon (15 ml) of blood drawn at 3 time points
- •Inclusion Criteria gastroparesis subjects
- •Gastroparesis subjects with a confirmed diagnosis of gastroparesis from a GI physician
- •Have a formal diagnosis of gastroparesis or are seeing the GI physician for symptoms related to gastroparesis
- •Aged 18-80 years
- •Willing to have electrodes placed in the external ear (ABVN arm)
- •Willing to perform vagal activity maneuver (Vagal arm)
- •Willing to have 1 tablespoon (15 ml) of blood drawn at 3 time points
排除标准
- •Unable to provide consent
- •Pregnant females
- •Prisoners
研究组 & 干预措施
Healthy Subjects
Subjects who have no gastric symptoms or conditions
干预措施: ML1101 Stimulus Isolator (Device)
Healthy Subjects
Subjects who have no gastric symptoms or conditions
干预措施: Vagal Maneuver (Procedure)
Gastroparesis Subjects
Subjects with a confirmed diagnosis of gastroparesis.
干预措施: ML1101 Stimulus Isolator (Device)
Gastroparesis Subjects
Subjects with a confirmed diagnosis of gastroparesis.
干预措施: Vagal Maneuver (Procedure)
结局指标
主要结局
Respiratory Changes in heart rate during stimulation
时间窗: 3 hours
To measure respiratory changes in heart rate during stimulation of the auricular branch of the vagal nerve and also during the vagal maneuvers phase.
Changes in gastric hormones
时间窗: 3 hours.
To measure the effect of stimulation of the auricular branch of the vagal nerve and/or of vagal maneuvers on gastric hormones.
Amplitude of vagal nerve compound action
时间窗: 3 hours
To measure the amplitude of vagal nerve compound action potentials during stimulation of the auricular branch of the vagal nerve and during vagal maneuvers.
Changes in amplitude of the surface electrogastrogram
时间窗: 3 hours.
To measure the changes of surface electrogastogram during stimulation of the auricular branch of the vagal nerve and also during the vagal maneuvers phase.
次要结局
未报告次要终点
研究者
Thomas V. Nowak
Professor
Indiana University