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临床试验/NCT01569789
NCT01569789已完成1 期

Effects of Auricular Vagus Nerve Stimulation on the Pro-inflammatory Cytokine Response in Healthy Adults

Northwell Health2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2012年1月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
24
试验地点
2
主要终点
TNF levels in the ex vivo LPS-stimulated whole blood

研究概览

简要总结

The autonomic (self-regulating) nervous system is important for the function of many organs in the body. The vagus nerve is part of the autonomic nervous system. The vagus nerve carries incoming information from the nervous system to the brain, providing information about what the body is doing, and it also transmits outgoing information which governs a range of reflex responses. It plays an important role in the immune system. A part of the vagus nerve is reachable for stimulation at specific locations in the ear.

The purpose of this study is to better understand how different ways of stimulating the vagus nerve at the ear can affect a chemical marker of inflammation found in human blood that is associated with a variety of inflammatory diseases such as rheumatoid arthritis and lupus. This information may lead to in future studies to see if stimulation of the vagus nerve can improve inflammation in chronic inflammatory diseases.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Between 18 and 60 years old
  • Currently healthy with no medical problems
  • Non-smoker

排除标准

  • History of any of the following: cardiac arrhythmia, coronary artery disease, chronic inflammatory disease, anemia, malignancy, depression, connective tissue disease (arthritis, vasculitis), neurologic disease, diabetes mellitus, renal disease, malignancy, dementia, psychiatric illness including active psychosis, or any other chronic medical condition
  • Use of cholinergic, anti-cholinergic, or beta-blocking medications
  • Family history of inflammatory disease
  • Pregnancy
  • Ear infection (otitis media or externa)
  • Implanted vagus nerve stimulator

结局指标

主要结局

TNF levels in the ex vivo LPS-stimulated whole blood

时间窗: 30 minutes (or 5 days) post stimulation

次要结局

  • IL-1B, IL-6, IL-8 and IL-10 levels will also be determined by using the same assay(30 minutes (or 5 days) post stimulation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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