Neurological Symptoms and Findings in Individuals Exposed to Indoor Air Pollutants

Completed

• Conditions: Exposure to Polluted Air

• Registration Number: NCT05111678
• Lead Sponsor: Turku University Hospital

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.

Study Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-08-02
• Study First Submitted QC: 2021-10-28
• Study First Posted: 2021-11-08
• Primary Completion: 2023-12-31
• Study Completion: 2024-03-31
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
[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

Name	Time	Method
Results from questionnaires	Baseline	Questionnaires about quality of life compared between the indoor air pollutant and neurological symptoms groups
Neurography measures	Baseline	Done additionally if clinical studies indicate necessary, to assess the state of peripheral nerves
Electromyography measures	Baseline	Done additionally if clinical studies indicate necessary, rating each examined muscle as normal/myopathic/neuropathic
Cerebrospinal fluid biomarkers	Baseline	Biomarkers measured from cerebrospinal fluid to assess the possible inflammatory state of individuals in different study groups
DTI-MRI metrics	Baseline	To evaluate the microstructural damage of the brain between individuals in different groups
Blood biomarkers	Baseline	Biomarkers measured from blood to assess the possible inflammatory state of individuals in different study groups

Trial Locations

Locations (1)

Turku PET Centre; 🇫🇮 Turku, Finland Proper, Finland