Effect of Electrical Stimulation of the Auricular Branch of the Vagus Nerve (ABVN) on Cervical Vagus Nerve Compound Nerve Action Potentials(CNAPs)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Amplitude of Vagus Nerve with Vagal Maneuvers
研究概览
简要总结
The vagus nerve is a largely-internal nerve that controls many bodily functions, including stomach function. Investigators hope that electrically stimulating the nerve around the external ear will also stimulate the internal vagus nerve. If it does, then investigators hope that this will help the treatment of patients with nausea and vomiting and disordered stomach function.
Investigators also hope to be able to measure the activity of the vagus nerve when it is stimulated in other ways. This could help investigators learn more about studying this nerve in the future.
详细描述
Only healthy volunteer subjects will be recruited and studied for this project. Volunteer subjects will undergo transcutaneous stimulation of the auricular branch of the vagus nerve (ABVN) to determine whether this modality will also produce cervical vagus nerve compound action potentials. Ear Stimulation Group
Another part of the study is to measure the vagal response to maneuvers which are known to stimulate the vagus nerve. The implementation of these vagal maneuvers will allow comparison of ABVN stimulation to traditional methods of vagal stimulation.- Vagal Maneuver Group
EAR STIMULATION GROUP:
This is a onetime visit only that involves baseline and test procedures.
Two MRI compatible electrodes will be placed in the auricle of the left ear, fixed by a plastic armature that wraps around the ear. The leads from the electrodes are connected to a stimulator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Aged 18-80 years
- •Willing to have electrodes placed in the external ear (ABVN arm)
- •Willing to perform vagal activity maneuver ( Vagal arm)
排除标准
- •Unable to provide consent
- •Having gastric motility issues as determined by the PI or Sub I
- •Taking medications affecting gastric motility
- •Pregnant females
研究组 & 干预措施
Healthy Subjects
Healthy volunteers aged 18-80 years old who will undergo vagus nerve stimulation.
干预措施: Transcutaneous Auricular Vagus Nerve Stimulation (Device)
Healthy Subjects
Healthy volunteers aged 18-80 years old who will undergo vagus nerve stimulation.
干预措施: Vagal Stimulation (Procedure)
结局指标
主要结局
Amplitude of Vagus Nerve with Vagal Maneuvers
时间窗: 3 years
measure the amplitude of vagal nerve compound action potentials in healthy volunteers with skin electrodes over right and left vagus nerve during Vagal Maneuvers.
Amplitude of the Vagus nerve with ABVN
时间窗: 3 years
measure the amplitude of vagal nerve compound action potentials in healthy volunteers with skin electrodes over right and left vagus nerve during ABVN stimulation
次要结局
- EGG and ABVN(3 years)
- EGG and Vagal maneuver(3 years)
研究者
Thomas V. Nowak
Clinical Professor and Principal Investigator
Indiana University