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Patterns of Neurocircuitry Activation In Severe Asthma

Patterns of Neurocircuitry Activation In Severe Asthma

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03230188
Acronym
PANISA
Enrollment
28
Registered
2017-07-26
Start date
2017-08-01
Completion date
2018-06-17
Last updated
2019-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Diseases

Keywords

asthma, neurocircuitry, severe asthma, mild to moderate asthma, neurocircuitry patterns

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.

Interventions

OTHERfunctional Magnetic Resonance Imaging (research grade)

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)

Sponsors

National Institutes of Health (NIH)
CollaboratorNIH
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Measures of Neural ActivityVisit 1 (1 day)% signal change in brain insula detected by functional Magnetic Resonance Imaging

Secondary

MeasureTime frameDescription
Airway Cellular and Molecular Inflammatory Response- NeutrophilsVisit 1 (1 day)Cell differential counts- Neutrophils (absolute neutrophil count, percent neutrophils)
Airway Cellular and Molecular Inflammatory Response- White Blood CellsVisit 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- EosinophilsVisit 1 (1 day)Cell differential counts- Eosinophils
Airway Cellular and Molecular Inflammatory Response- LymphocytesVisit 1 (1 day)Cell differential counts- Lymphocytes (absolute lymphocyte count, percent lymphocytes)
Airway Cellular and Molecular Inflammatory Response- Monocytes/MacrophagesVisit 1 (1 day)Cell differential counts- Monocytes/Macrophages (absolute monocyte count, percent monocytes)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026