Using a Transcutaneous Electrical Auricular Stimulator to Harness the Cholinergic Anti-Inflammatory Pathway
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Lipopolysaccharide stimulated levels of TNF in whole blood.
研究概览
简要总结
Persistent chronic inflammation is an important underlying event in multiple diseases including rheumatoid arthritis, inflammatory bowel diseases and type 2 diabetes. These disorders are characterized as inflammatory in part because of the important mediating role of pro-inflammatory cytokines in their pathogenesis. This study will investigate whether transcutaneous auricular electrical stimulation of the vagus nerve will affect and decrease the inflammatory cytokine response in healthy individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18-60 years,
- •Currently healthy with no medical problems
- •Able and willing to give written informed consent and comply with the requirements of the study protocol.
排除标准
- •History of any of the following: cardiac arrhythmia, coronary artery disease, autoimmune disease, chronic inflammatory disease, anemia, malignancy, depression, neurologic disease, diabetes mellitus, renal disease, malignancy, dementia, psychiatric illness including active psychosis, or any other chronic medical condition.
- •Family history of inflammatory disease
- •Treatment with an anti-cholinergic medication, including over the counter medications,
- •Implantable electronic devices such as pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators.
- •Current tobacco or nicotine user (to limit potential confounding effects of exposure to nicotine),
- •Chronic inflammatory disorders
- •Investigational drug and/or treatment during the 28 days or seven half-lives of the investigational drug prior to the start of study drug dosing (Day 0), whichever is the greater length of time,
- •Any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to a study intervention,
- •Pregnancy or lactation (Pregnancy status & lactation will be determined via self-report),
- •Implanted vagus nerve stimulator
- •Inability to comply with study procedures
- •Ear infection (otitis media or externa)
结局指标
主要结局
Lipopolysaccharide stimulated levels of TNF in whole blood.
时间窗: 4 hours
Whole blood will be taken from patients and stimulated by lipopolysaccharide. Levels of TNF produced by the cells in the whole blood after 4 hours of incubation will be measured.
次要结局
- Percentage of subjects with treatment emergent adverse events(1 hour)
- Lipopolysaccharide stimulated levels of cytokines such as IL-1, IL-6, IL-8, IL-10 and HMGB1 in whole blood.(4 hours)
研究者
Cynthia Aranow, MD
Investigator
Northwell Health