Patterns of Neurocircuitry Activation In Severe Asthma (PANISA)
2019年1月22日 更新者：University of Wisconsin, Madison
The overall purpose of the study is to compare the patterns of neurocircuitry activation in severe asthmatics vs. mild to moderate and healthy controls.
The Investigators hypothesize that neurocircuitry activation increases with asthma severity, producing different neurocircuitry patterns for severe asthmatics than those of mild to moderate asthmatics or non-asthmatics.
研究概览
地位
完全的
条件
详细说明
To begin to further address possible relationships of asthma and brain function, the investigators propose the following hypothesis, "patients with defined characteristics of severe asthma will have distinct patterns of persistent neurocircuitry activation.
The investigators further propose that the detection of ongoing neurocircuitry activation occurs because of persistent and active airway inflammation in severe asthma.
Finally, the investigators propose that the intensity of specific neurocircuitry activation will relate to the severity of underlying asthma.
研究类型
观察性的
注册 (实际的)
28
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Wisconsin
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Madison、Wisconsin、美国、53792
- UW Madison
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Adults ages 18 and older who are currently rolled in the Severe Asthma Research Program III study at the University of Wisconsin-Madison (all subjects have severe asthma)
描述
Inclusion Criteria:
- Currently enrolled in Severe Asthma Research Program III (2012-0571) study
- Has severe asthma
- Is a male or female with no health concerns that might affect the outcome of the study
- Provided a negative urine pregnancy test prior to visit (Females only)
- Capable and willing to grant written informed consent and cooperate with study procedures and requirements (investigator discretion)
- Is able to tolerate a simulated functional Magnetic Resonance Imaging brain scanning session
- Is able to give valid informed consent to participate by signing and dating a written consent form
Exclusion Criteria:
- Uses psychotropic medication that might affect function of neurocircuitry implicated in our hypotheses (at the discretion of a study physician or Co-Investigator)
- Has one or more contraindications for functional Magnetic Resonance Imaging
- Has needle phobia or claustrophobia
- Unable to distinguish specific colors used in Stroop task
- History of a diagnosed Bipolar Disorder, Schizophrenia, or Schizoaffective Disorder
- Is a pregnant or lactating female
- Has had an upper or lower respiratory infection within 1 month of the visit
- Has unstable asthma as indicated by self-report of increased symptoms or increased beta-agonist use over the 2 weeks preceding the visit
- Is a current smoker (defined as smoked within the last year) or a former smoker with a history of >5 pack years
- Any condition which, in the opinion of the investigator, might interfere with participation in the study
- Inability or unwillingness to perform required study procedures
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Severe Asthmatics
Individuals with severe asthma that are already enrolled in the University of Wisconsin Severe Asthma Research Program III study will fill out asthma and psychological questionnaires (non-diagnostic), will undergo Cognitive Function Testing (non-diagnostic), and will undergo a simulated and actual functional Magnetic Resonance Imaging (research grade) scan.
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Subjects will undergo a simulated and actual functional Magnetic Resonance Imaging scan.
Subjects will take non-diagnostic cognitive function tests
Subjects will fill out asthma and psychological questionnaires (non-diagnostic)
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Measures of Neural Activity
大体时间：Visit 1 (1 day)
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% signal change in brain insula detected by functional Magnetic Resonance Imaging
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Visit 1 (1 day)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Airway Cellular and Molecular Inflammatory Response- White Blood Cells
大体时间：Visit 1 (1 day)
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Cell differential counts- Total White Blood Cell count (sum of absolute counts for: Eosinophils, Monocytes, Neutrophils, Basophils, Lymphocytes)
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Visit 1 (1 day)
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Airway Cellular and Molecular Inflammatory Response- Eosinophils
大体时间：Visit 1 (1 day)
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Cell differential counts- Eosinophils
|
Visit 1 (1 day)
|
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Airway Cellular and Molecular Inflammatory Response- Lymphocytes
大体时间：Visit 1 (1 day)
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Cell differential counts- Lymphocytes (absolute lymphocyte count, percent lymphocytes)
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Visit 1 (1 day)
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Airway Cellular and Molecular Inflammatory Response- Monocytes/Macrophages
大体时间：Visit 1 (1 day)
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Cell differential counts- Monocytes/Macrophages (absolute monocyte count, percent monocytes)
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Visit 1 (1 day)
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Airway Cellular and Molecular Inflammatory Response- Neutrophils
大体时间：Visit 1 (1 day)
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Cell differential counts- Neutrophils (absolute neutrophil count, percent neutrophils)
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Visit 1 (1 day)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：William W Busse, MD、The University of Wisconsin School of Medicine and Public Health
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年8月1日
初级完成 (实际的)
2018年6月17日
研究完成 (实际的)
2018年6月17日
研究注册日期
首次提交
2017年6月28日
首先提交符合 QC 标准的
2017年7月24日
首次发布 (实际的)
2017年7月26日
研究记录更新
最后更新发布 (实际的)
2019年1月24日
上次提交的符合 QC 标准的更新
2019年1月22日
最后验证
2019年1月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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