Patterns of Neurocircuitry Activation In Severe Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Measures of Neural Activity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Measures of Neural Activity
时间窗: Visit 1 (1 day)
% signal change in brain insula detected by functional Magnetic Resonance Imaging
次要结局
- Airway Cellular and Molecular Inflammatory Response- White Blood Cells(Visit 1 (1 day))
- Airway Cellular and Molecular Inflammatory Response- Eosinophils(Visit 1 (1 day))
- Airway Cellular and Molecular Inflammatory Response- Lymphocytes(Visit 1 (1 day))
- Airway Cellular and Molecular Inflammatory Response- Monocytes/Macrophages(Visit 1 (1 day))
- Airway Cellular and Molecular Inflammatory Response- Neutrophils(Visit 1 (1 day))