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OpenTrials
Completed

NCT Number: NCT03230188

Patterns of Neurocircuitry Activation In Severe Asthma

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UW Madison

Madison, Wisconsin, 53792, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

functional Magnetic Resonance Imaging (research grade)

Other

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

Cognitive Function Testing (non-diagnostic)

Other

Subjects will take non-diagnostic cognitive function tests

Asthma and Psychological Questionnaires (non-diagnostic)

Other

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

Primary outcomes

  1. Measures of Neural Activity

    Time frame: Visit 1 (1 day)

    % signal change in brain insula detected by functional Magnetic Resonance Imaging

Secondary outcomes

  1. Airway Cellular and Molecular Inflammatory Response- White Blood Cells

    Time frame: Visit 1 (1 day)

    Cell differential counts- Total White Blood Cell count (sum of absolute counts for: Eosinophils, Monocytes, Neutrophils, Basophils, Lymphocytes)

  2. Airway Cellular and Molecular Inflammatory Response- Eosinophils

    Time frame: Visit 1 (1 day)

    Cell differential counts- Eosinophils

  3. Airway Cellular and Molecular Inflammatory Response- Lymphocytes

    Time frame: Visit 1 (1 day)

    Cell differential counts- Lymphocytes (absolute lymphocyte count, percent lymphocytes)

  4. Airway Cellular and Molecular Inflammatory Response- Monocytes/Macrophages

    Time frame: Visit 1 (1 day)

    Cell differential counts- Monocytes/Macrophages (absolute monocyte count, percent monocytes)

  5. Airway Cellular and Molecular Inflammatory Response- Neutrophils

    Time frame: Visit 1 (1 day)

    Cell differential counts- Neutrophils (absolute neutrophil count, percent neutrophils)

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)

Registry information

Acronym: PANISA

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 26, 2017
Registry last updated
Jan 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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