Effects of Transauricular Vagal Nerve Stimulation on Electrogastrography (EGG) and Heart Rate Variability (HRV) in Healthy Subjects, Functional Dyspepsia, and Gastroparesis
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 60
- 主要终点
- Establish EGG/HRV parameters and effects following taVNS
研究概览
简要总结
The goal of this study is to establish parameters of gastric myoelectrical activity and heart rate variability in healthy human subjects and compare and contrast them to those with gastroparesis and functional dyspepsia, at baseline and following taVNS.
详细描述
This is a prospective pilot study assessing the relationship of electrogastrography and heart rate variability, with transauricular stimulation of the vagal nerve in healthy subjects compared to gastroparesis and functional dyspepsia patients. The investigators plan to recruit a total of 60 patients: 20 healthy volunteers, 20 gastroparesis, and 20 functional dyspepsia patients. Participants will undergo two testing sessions in which electrogastrography (EGG) and heart rate variability (HRV) will be measured using electrodes following transauricular vagal nerve stimulation (tAVNS) at various frequencies.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female.
- •Age 18-85 years.
- •Healthy volunteer or established diagnosis of idiopathic, diabetic, or postsurgical gastroparesis and functional dyspepsia.
- •Patient is capable of giving informed consent.
- •Patient is on stable doses of other medications for gastroparesis or functional dyspepsia for preceding 4 weeks prior to enrollment (including cholinergics, anti-cholinergics, dopamine and serotonin receptor agonists/antagonists, motility agents, neuromodulators, herbals).
排除标准
- •Any diagnosis of systemic autonomic dysfunction.
- •Use of narcotic, anticholinergic, cholinergic, or promotility medications in preceding 2 weeks of study.
- •Enteric feeding tubes.
- •Parenteral nutrition.
- •Severe disease flare requiring hospitalization or ER visits within 3 months of study.
- •Untreated depression or suicidal thoughts.
- •Pregnant/breastfeeding women.
- •History of gastric pacemaker implantation.
- •Implantable electronic devices (i.e. cardiac pacemakers)
- •Extrinsic myopathy/neuropathy
- •Vagal nerve injury.
- •High risk cardiac arrhythmias (high grade AV block, atrial fibrillation, atrial flutter).
- •History of dumping syndrome.
- •History of rapid gastric emptying.
- •Severe allergy to skin adhesives.
- •Concurrent enrollment in other clinical trials.
结局指标
主要结局
Establish EGG/HRV parameters and effects following taVNS
时间窗: 3-5 years
The first primary outcome measure will be to establish measures of EGG and HRV parameters in healthy volunteers and determine effects of tAVNS on EGG and HRV. The HRV parameters to be measured will include mean heart rate (HR), standard deviation of HR, mean respiratory rate (RR) interval, standard deviation of RR interval, low/high frequency (LF, HF, LF/HF), normalized LF, and normalized HF. The EGG parameters to be measured will be of gastric slow wave power, gastric slow wave propagation, and phase gradient directionality.
次要结局
- Determine deviations in EGG/HRV parameters and effects following taVNS(3-5 years)
研究者
Linda Nguyen
Clinical Professor of Medicine
Stanford University