Neurological Symptoms and Findings in Individuals Exposed to Indoor Air Pollutants

NCT05111678 | Completed

• 1 other identifier: 1/2021
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Exposure to Polluted Air

Outcome Measures

Primary Outcomes (1)

• [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 Outcomes (6)

• DTI-MRI metrics

  Baseline

• Results from questionnaires

  Baseline

• Blood biomarkers

  Baseline

• Neurography measures

  Baseline

• Electromyography measures

  Baseline

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Turku University Hospital: lead

Study Sites (1)

Turku PET Centre

Turku, Southwest Finland, 20520, Finland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and cerebrospinal fluid

Study Officials

• Laura Airas, MD,Professor

  Turku University Hospital, division of clinical neurosciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: November 8, 2021
• Study Start: April 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: March 31, 2024
• Last Updated: April 10, 2024

Record last verified: 2024-04

Locations

FI (1)