Neurological Symptoms and Findings in Individuals Exposed to Indoor Air Pollutants

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

Study Overview

• Status: Completed
• Conditions: Exposure to Polluted Air

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 Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• Finland
  • Finland Proper
    • Turku, Finland Proper, Finland, 20520
      • Turku PET Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
[11C]PK11195 binding in the brain	Change in microglial activity in the brains of the individuals in different study groups as measured by [11C]PK11195 PET imaging	Baseline

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Turku University Hospital
• Investigators: Principal Investigator: Laura Airas, MD,professor, Turku University Hospital, division of clinical neurosciences

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: August 2, 2021
• First Submitted That Met QC Criteria: October 28, 2021
• First Posted (Actual): November 8, 2021

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 1/2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No