Neurological Symptoms and Findings in Individuals Exposed to Indoor Air Pollutants

Sponsor
Turku University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05111678
Collaborator
(none)
125
1
28
4.5

Study Details

Study Description

Brief Summary

To evaluate neurological findings with TSPO-PET and MRI in patients who have been exposed to indoor air pollutants and have potentially neurological symptoms.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Health problems related to indoor air pollutants have been studied for several decades but there is still not sufficient scientific evidence to prove the association between many of the described symptoms and exposure to mold and other air pollutants.

    This research aims on studying the activation of microglia and inflammation in the brains of individuals exposed to indoor air pollutants having neurological symptoms with MRI and TSPO-PET imaging, questionnaires and biomarkers and compare the findings to individuals having neurological conditions without exposure to indoor air pollutants as well as healthy controls.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    125 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Neurological Symptoms and Findings in Individuals Exposed to Indoor Air Pollutants
    Actual Study Start Date :
    Apr 1, 2021
    Anticipated Primary Completion Date :
    May 1, 2023
    Anticipated Study Completion Date :
    Aug 1, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Indoor air pollutant groups

    50 patients that have been exposed to indoor air pollutants

    Neurological symptoms groups

    50 patients with neurological symptoms possibly due to adverse external exposure without any exposure to indoor air pollutants

    Healthy controls

    25 healthy age- and gender-matched controls

    Outcome Measures

    Primary Outcome Measures

    1. [11C]PK11195 binding in the brain [Baseline]

      Change in microglial activity in the brains of the individuals in different study groups as measured by [11C]PK11195 PET imaging

    Secondary Outcome Measures

    1. DTI-MRI metrics [Baseline]

      To evaluate the microstructural damage of the brain between individuals in different groups

    2. Results from questionnaires [Baseline]

      Questionnaires about quality of life compared between the indoor air pollutant and neurological symptoms groups

    3. Blood biomarkers [Baseline]

      Biomarkers measured from blood to assess the possible inflammatory state of individuals in different study groups

    4. Neurography measures [Baseline]

      Done additionally if clinical studies indicate necessary, to assess the state of peripheral nerves

    5. Electromyography measures [Baseline]

      Done additionally if clinical studies indicate necessary, rating each examined muscle as normal/myopathic/neuropathic

    6. Cerebrospinal fluid biomarkers [Baseline]

      Biomarkers measured from cerebrospinal fluid to assess the possible inflammatory state of individuals in different study groups

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    All:
    • Signing the informed consent form

    • Adults over 18 years of age

    Indoor air pollutant groups:
    • Exposed to indoor air pollutants

    • Neurological symptoms

    Neurological symptoms groups:
    • Neurological symptoms possibly due to adverse external exposure
    Healthy controls:
    • Reported healthy person
    Exclusion Criteria:
    All:
    • Pregnancy or breast-feeding

    • Corticosteroid treatment within 4 weeks of imaging

    • Patients with claustrophobia, or a history of moderate to severe anxiety disorder or panic attacks (which could potentially lead to preterm termination of the imaging)

    • Contraindication to PET scan and MRI investigations

    • Exposure to experimental radiation in the past 12 months such that radiodosimetry limits would be exceeded by participating in this study.

    • Intolerance to previous PET scans; i.e. previous hypersensitivity reactions to any PET ligand or imaging agent or failure to participate in and comply with previous PET scans.

    Neurological symptoms groups and healthy controls:
    • Exposure to indoor air pollutants

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Turku PET Centre Turku Finland Proper Finland 20520

    Sponsors and Collaborators

    • Turku University Hospital

    Investigators

    • Principal Investigator: Laura Airas, MD,Professor, Turku University Hospital, division of clinical neurosciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Turku University Hospital
    ClinicalTrials.gov Identifier:
    NCT05111678
    Other Study ID Numbers:
    • 1/2021
    First Posted:
    Nov 8, 2021
    Last Update Posted:
    Nov 8, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Nov 8, 2021