Clinical trial NCT05111678: Neurological Symptoms and Findings in Individuals Exposed to Indoor Air Pollutants
Official title: Neurological Symptoms and Findings in Individuals Exposed to Indoor Air Pollutants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exposure to Polluted Air
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
First posted: 2021-11-08
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will recruit 50 patients who have been exposed to indoor air pollutants and have possibly neurological symptoms. For comparison the study will recruit also 50 patients with neurological symptoms due to a possible adverse external exposure and who have not been exposed to indoor air pollutants. Additionally, 25 healthy controls will be included.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: [11C]PK11195 binding in the brain
timeFrame: Baseline
Secondary outcomes:
measure: DTI-MRI metrics
timeFrame: Baseline
measure: Results from questionnaires
timeFrame: Baseline
measure: Blood biomarkers
timeFrame: Baseline
measure: Neurography measures
timeFrame: Baseline
measure: Electromyography measures
timeFrame: Baseline
measure: Cerebrospinal fluid biomarkers
timeFrame: Baseline
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku PET Centre
state: Finland Proper
Study officials:
affiliation: Turku University Hospital, division of clinical neurosciences
name: Laura Airas, MD,Professor
role: PRINCIPAL_INVESTIGATOR
References: