Patterns of Neurocircuitry Activation In Severe Asthma

Completed

• Conditions: Lung Diseases
• Interventions: Other: functional Magnetic Resonance Imaging (research grade); Other: Cognitive Function Testing (non-diagnostic); Other: Asthma and Psychological Questionnaires (non-diagnostic)

• Registration Number: NCT03230188
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-06-28
• Study First Submitted QC: 2017-07-24
• Study First Posted: 2017-07-26
• Study Start: 2017-08-01
• Primary Completion: 2018-06-17
• Study Completion: 2018-06-17
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-22
• Last Update Posted: 2019-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Severe Asthmatics	Cognitive Function Testing (non-diagnostic)	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.
Severe Asthmatics	Asthma and Psychological Questionnaires (non-diagnostic)	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.
Severe Asthmatics	functional Magnetic Resonance Imaging (research grade)	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.

Primary Outcome Measures

Name	Time	Method
Measures of Neural Activity	Visit 1 (1 day)	% signal change in brain insula detected by functional Magnetic Resonance Imaging

Secondary Outcome Measures

Name	Time	Method
Airway Cellular and Molecular Inflammatory Response- White Blood Cells	Visit 1 (1 day)	Cell differential counts- Total White Blood Cell count (sum of absolute counts for: Eosinophils, Monocytes, Neutrophils, Basophils, Lymphocytes)
Airway Cellular and Molecular Inflammatory Response- Eosinophils	Visit 1 (1 day)	Cell differential counts- Eosinophils
Airway Cellular and Molecular Inflammatory Response- Lymphocytes	Visit 1 (1 day)	Cell differential counts- Lymphocytes (absolute lymphocyte count, percent lymphocytes)
Airway Cellular and Molecular Inflammatory Response- Monocytes/Macrophages	Visit 1 (1 day)	Cell differential counts- Monocytes/Macrophages (absolute monocyte count, percent monocytes)
Airway Cellular and Molecular Inflammatory Response- Neutrophils	Visit 1 (1 day)	Cell differential counts- Neutrophils (absolute neutrophil count, percent neutrophils)

Trial Locations

Locations (1)

UW Madison; 🇺🇸 Madison, Wisconsin, United States