Patterns of Neurocircuitry Activation In Severe Asthma

NCT ID: NCT03230188

Last Updated: 2019-01-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-01

Study Completion Date

2018-06-17

Brief Summary

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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

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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.

Conditions

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Lung Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

functional Magnetic Resonance Imaging (research grade)

Intervention Type OTHER

Subjects will undergo a simulated and actual functional Magnetic Resonance Imaging scan.

Cognitive Function Testing (non-diagnostic)

Intervention Type OTHER

Subjects will take non-diagnostic cognitive function tests

Asthma and Psychological Questionnaires (non-diagnostic)

Intervention Type OTHER

Subjects will fill out asthma and psychological questionnaires (non-diagnostic)

Interventions

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functional Magnetic Resonance Imaging (research grade)

Subjects will undergo a simulated and actual functional Magnetic Resonance Imaging scan.

Intervention Type OTHER

Cognitive Function Testing (non-diagnostic)

Subjects will take non-diagnostic cognitive function tests

Intervention Type OTHER

Asthma and Psychological Questionnaires (non-diagnostic)

Subjects will fill out asthma and psychological questionnaires (non-diagnostic)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William W Busse, MD

Role: PRINCIPAL_INVESTIGATOR

The University of Wisconsin School of Medicine and Public Health

Locations

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UW Madison

Madison, Wisconsin, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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5R01HL123284-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2017-0208

Identifier Type: -

Identifier Source: org_study_id

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