Auricular Vagal Nerve Stimulation for Gastric and Brain Outcomes
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Stomach activity during gastric magnetic resonance imaging (MRI)
研究概览
简要总结
This study will determine how noninvasive nerve stimulation affects human brain, stomach, and autonomic activity.
详细描述
Scientific research into the basic mechanisms underlying neuromodulation is relatively recent and incomplete. The purpose of the proposed study is to determine how a form of neuromodulation, transcutaneous electro-accupoint stimulation, which is non-invasive and non-painful, affects human brain, stomach, and autonomic activity. We will accomplish this by integrating whole brain functional MRI (fMRI) methodologies with gastric MRI and physiological monitoring.
This study will comprise 3 functional magnetic resonance imaging (fMRI) brain-gut scans, all while receiving the neuromodulation with varying parameters. Participants will also have their heart rate, breathing, and gastric activity monitored during all visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants are not made aware of the expectation manipulation nor their group assignment until the end of the final visit, at which point they are debriefed.
Outcomes assessors will be blind to group assignments until analysis is complete.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults 18-65
- •Functional dyspepsia
排除标准
- •Any condition contraindicating an fMRI brain scan
结局指标
主要结局
Stomach activity during gastric magnetic resonance imaging (MRI)
时间窗: 30 minutes
Gastric accommodation and sensitivity change between active and inactive auricular tVNS
Brain activity during functional magnetic resonance imaging (fMRI)
时间窗: 1 hour
Blood oxygen-level dependent (BOLD) signal change between active and inactive auricular tVNS
次要结局
- Electrogastrography (EGG)(2 hours)
- Electrocardiography (ECG)(2 hours)
- Respiration(2 hours)
- Skin Conductance Levels (SCL)(2 hours)
研究者
Vitaly Napadow, Ph.D., Lic.Ac.
Assistant Professor
Massachusetts General Hospital