Determining the Impact of Air Pollution on the Developing Brain

Attention Deficit Hyperactivity Disorder Clinical Trial

— NeuroSmog  

Official title:

NeuroSmog: Determining the Impact of Air Pollution on the Developing Brain

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04574414
• Other study ID #: KE_24042019A
• Status: Not yet recruiting
• Start date: October 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2020
• Source: Jagiellonian University
• Contact: Marcin Szwed, Dr. hab.
• Phone: 12 663 24 40
• Email: m.szwed[@]uj.edu.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

• Background: Recent studies have linked exposure to airborne particulate matter (PM) to neurodevelopmental outcomes but the findings are mixed and mechanisms are unclear. We aim to determine the impact of PM on the developing brain of schoolchildren in Poland, a European country characterized by very high levels of air pollution. The investigators aim to determine the impact of PM on the developing brain of schoolchildren in Poland, a European country characterized by very high levels of air pollution.

• Study area: 19 towns in three voivodeships (Lesser Poland, Silesian, Opole) in the southern Poland. To reduce confounding by urbanicity and at the same time, to achieve sufficient contrasts in PM levels without too high logistic costs, towns were selected by size (big and small) and by PM levels (high, medium and low).

• Design: Case-control study with 800 children recruited over two school years, with two population controls per one ADHD case. Suspected cases will be recruited in specialized facilities and presumably ADHD-free children will be recruited in primary schools.

• Exposure assessment: Poland-wide PM and other air pollutants' grids will be created for the years 2006 to 2021 using statistical models to incorporate land use data, estimates from transport models, satellite observations and air pollution measurements from Polish monitoring network. Prenatal, early-life, lifelong and concurrent exposures will be calculated.

• Psychological testing: Every child and their parents will complete a series of psychological tests and interviews that will be conducted during their three visits to the recruitment facility.

• Neuroimaging: Each participant will undergo a Magnetic Resonance Imaging (MRI) scanning session that will be performed accordingly to the Human Connectome Adolescent Brain Cognitive Development project recommendations. Scanning will be performed on a single scanner in Krakow.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 800
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 13 Years

Eligibility

Inclusion Criteria:

• Attending school in one of the specified towns

• Age 10-13 years (4th-6th grade)

• Native Polish speaker

• Normal or above intelligence

• Standard educational opportunities

• Normal or corrected to normal visual and auditory acuity

• No gross sensory deficit, no gross behavioural problems

• No history of neurological disease

Exclusion Criteria:

• Autism spectrum disorder (ASD)

• FAS

• FAE

• Intellectual disability

• Metabolic disorders

• Genetic disorders

• Epilepsy

• Cerebral palsy

• Mood disorders

• Tourette Syndrome

• Other illnesses including pharmacotherapy

• Apgar score < 8

• Low birth weight (below 2500 g)

• Preterm birth (below 35th weeks of gestation)

Related Conditions & MeSH terms

• Attention
• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Executive Functioning
• Social Functioning

Intervention

Diagnostic Test:
• Psychological testing and MRI imaging
Every child will have three sessions with psychologists and be diagnosed as having or not having ADHD. Every child will be invited to Krakow to undergo MRI measurements, including resting-state and event-related functional MRI, Diffusion Tensor Imaging (DTI), and T1/T2 structural MRI.

Locations

Country	Name	City	State
Poland	Institute of Psychology	Kraków

Sponsors (3)

Lead Sponsor	Collaborator
Jagiellonian University	Foundation for Polish Science, Institute of Environmental Protection - National Research Institute (IOS-PIB)

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Attention Deficit Hyperactivity Disorder (ADHD)	ADHD and comorbidities will be assessed by Conners 3 questionnaire	October 1, 2020 until December 31, 2022
Primary	Cognitive functioning	Memory, attention, and executive functions measurement will be assessed by Diagnostic battery for cognitive functions evaluation (PU1)	October 1, 2020 until December 31, 2022
Primary	Attention control	Attention Network Test (ANT) will be used.	October 1, 2020 until December 31, 2022
Primary	Sustained and selective attention	Computer Conners Continuous Performance Task (CPT) will be used.	October 1, 2020 until December 31, 2022
Primary	Inhibition control	Conditioned Approach Response Inhibition Task (CARIT) will be used as part of MRI measurements.	October 1, 2020 until December 31, 2022
Primary	Inhibition control	Go/No Go task will be used as part of MRI measurements.	October 1, 2020 until December 31, 2022
Secondary	Full-Scale Intelligence Quotient (IQ)	IQ will be measured by Stanford-Binet Intelligence Scales, 5th Edition (SB5).	October 1, 2020 until December 31, 2022
Secondary	Family functioning	Polish adaptation of the FACES-IV (Flexibility and Cohesion Evaluation Scales; SOR) will be used to estimate social functioning of the children (family functioning).	October 1, 2020 until December 31, 2022
Secondary	Relationships with siblings	Siblings Relationship Questionnaire (KRR), which is a supplement for the SOR Scale will be used to assess social functioning of the children (relationships with siblings).	October 1, 2020 until December 31, 2022
Secondary	Behavioural, emotional, and social problems	Youth Self-Report Scale (YSR) will be used for this assessment.	October 1, 2020 until December 31, 2022
Secondary	Behavioural problems	Child Behaviour Checklist (CBCL) questionnaire will collect information on the eight syndrome domains: anxious/depressed, depressed, somatic complaints, social problems, thought problems, attention problems, rule-breaking behaviour, aggressive behaviour	October 1, 2020 until December 31, 2022