An interventional study of MRI task in Pollution; Exposure and Neurodevelopmental Disorders, sponsored by New York State Psychiatric Institute. Enrolling by invitation at 2 sites in 2 countries. Open to participants aged 6 Months to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by New York State Psychiatric Institute · Not applicable, Interventional, and Basic science
This study seeks to understand the relationship between prenatal maternal air pollution exposure and offspring risk for ADHD and examine two potential -modifiable- mechanisms: prenatal maternal inflammation and offspring sleep problems. We will employ a longitudinal neuroimaging study design and leverage a well-characterized intergenerational cohort of Puerto Ricans to address prior literature's limitations. This will be the first study to use infant neuroimaging to disassociate the effects of prenatal pollution exposure from those of postnatal pollution exposure, adversity and disadvantage, and offspring genetic risk for ADHD.
The NYSPI site is currently paused and has been paused since an institutional pause on human subjects research began in June, 2023.
The U.S. Department of Health and Human Services (HHS) Office of Human Research Protections (OHRP) issued an FWA restriction on NYSPI research that also included a pause of human subjects research as of June 23, 2023.
352 studies on the registry are indexed under Neurodevelopmental Disorders; 141 are open to participants now.
This study's planned enrollment of 182 is above the median of 88 across 217 interventional studies indexed under Neurodevelopmental Disorders.
Browse Neurodevelopmental Disorders studies →New York State Psychiatric Institute is the lead sponsor of 435 studies on the registry; 27 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 45 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants will be in the same arm.
Other: MRI task
Task fMRI (Simon) \[ Time Frame: Children will undergo MRI scans when they are 6-11 years of age. \] Children will also complete a task, which will allow exploratory analyses of the functionality of attention-related neural circuits. The Simon fMRI task is a non-verbal task equivalent to the Stroop that tests sustained attention and inhibitory control and discriminates children with and without ADHD. Exploratory fMRI time-series data for each participant will be modeled using a general linear model with 3 predictors: congruent correct, incongruent correct, and incorrect. Contrast images for each participant (e.g., incongruent-minus-congruent) will be generated and entered into a group-level random-effects model. Analyses are exploratory, and will focus on frontal lobe activity during each type of trial.
Frontal lobe and corpus callosum volumes
Frontal lobe and corpus callosum volumes in will be measure in offspring. Bilateral middle frontal cortex and corpus callosum volumes will be used in hypothesis testing.
Time frame: Children will be scanned either at 6-36 months or 6-11 years of age, depending on when the participants are enrolled.
Exploratory- Task fMRI (Simon)
Children will also complete a task, which will allow exploratory analyses of the functionality of attention-related neural circuits. The Simon fMRI task is a non-verbal task equivalent to the Stroop that tests sustained attention and inhibitory control and discriminates children with and without ADHD. Exploratory fMRI time-series data for each participant will be modeled using a general linear model with 3 predictors: congruent correct, incongruent correct, and incorrect. Contrast images for each participant (e.g., incongruent-minus-congruent) will be generated and entered into a group-level random-effects model. Analyses are exploratory, and will focus on frontal lobe activity during each type of trial.
Time frame: Children will undergo MRI scans when they are 6-11 years of age.
Plan to share: Undecided — De-identified participant level data will be shared as required by NIH's 2003 Data Sharing Policy. The data sharing plan and elements are still being determined.
No publications or documents are linked to this record.
Started Jan 2023 (actual). Primary completion is estimated for Jun 2028, 64 months after the start.
Of 142 non-industry interventional studies with no phase under Neurodevelopmental Disorders, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 52. This study's planned 64 months is above that.
Counting every sponsor, half of 148 studies reached it within 30 months; a quarter within 15 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Neurodevelopmental Disorders →
New York State Psychiatric Institute →