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临床试验/NCT01692561
NCT01692561已完成不适用

Study Title: Brain Transmitters/Metabolites, Magnetic Resonance Spectroscopy, and Brain Connectivity: Diagnostic Strategies to Study the Effects of Non-Pharmacologic Therapies for Dysautonomia and Chronic Nausea

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2012年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
Assessment of the implication of dysautonomia on the brain and better evaluate its potential mechanistic process.

研究概览

简要总结

The purpose of this research study is to better understand what causes dysautonomia and how this affects blood pressure and pulse. Dysautonomia is a condition of the autonomic nervous system. It is associated with fluctuations in blood pressure and pulse and may cause symptoms of nausea and belly pain, fatigue, excessive thirst, lightheadedness, dizziness, feelings of anxiety or panic, and fainting. A common example of dysautonomia is postural orthostatic tachycardia syndrome or POTS. Sometimes symptoms worsen when people move from lying down to standing, called orthostatic intolerance. We would like to learn more about the link between orthostatic intolerance and nausea. While medications currently used to treat orthostatic intolerance and nausea have proven to be effective in some patients, this may not be the best treatment for everyone as long term use could pose certain risks including high blood pressure. In order to provide a more focused and safer treatment for patients suffering from nausea and orthostatic intolerance, we have looked at how the blood pressure, pulse, and certain blood tests change during a tilt table test. This test helps to create the same circumstances that patients with orthostatic intolerance experience when they stand. To better understand if some of these problems are associated with the brain, we will study MRI in patients with dysautonomia compared to children without dysautonomia. This information may allow us to use alternative and safer treatments in the future.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • subjects who have completed tilt autonomic testing
  • subjects from 9 - 18 years of age

排除标准

  • subjects who have a metabolic, mechanical, or mucosal inflammatory cause which has been defined to explain their gastrointestinal symptoms
  • Patients with cardiac or cardiovascular disease, malignancy, psychiatric illness, neurodevelopmental delay, or other co-morbid conditions
  • Patients with with pacemakers, implanted devices, or any other MRI contraindications will be excluded from this study.

结局指标

主要结局

Assessment of the implication of dysautonomia on the brain and better evaluate its potential mechanistic process.

时间窗: Assessments will occur in a one and a half hour visit.

The first objective of the proposed project is to study central transmitter/metabolite profiles using in vivo 1H Magnetic Resonance Spectroscopy (MRS) in children with dysautonomia diagnosed by tilt table testing compared to healthy children without symptoms of dysautonomia. The second objective will be to determine whether dysautonomia associated with nausea and cardiovascular instability shares common alterations in brain networks. We will be using cognitive and sensory processing tasks based on our prior experience with both traditional fMRI and network analyses.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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