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OpenTrials
Completed

NCT Number: NCT05111678

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Turku PET Centre

Turku, Southwest Finland, 20520, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Primary outcomes

  1. [11C]PK11195 binding in the brain

    Time frame: Baseline

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

Secondary outcomes

  1. DTI-MRI metrics

    Time frame: Baseline

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

  2. Results from questionnaires

    Time frame: Baseline

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

  3. Blood biomarkers

    Time frame: Baseline

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

  4. Neurography measures

    Time frame: Baseline

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

  5. Electromyography measures

    Time frame: Baseline

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

  6. Cerebrospinal fluid biomarkers

    Time frame: Baseline

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

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Nov 8, 2021
Registry last updated
Apr 10, 2024

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.