PERINE : Effect of Prenatal Exposure to Neurotoxicants on the Developing Brain : an MRI Study

Study Overview
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Brief Summary
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This project aims at evaluating the consequences of prenatal exposure to neurotoxicants (solvents, organophosphate pesticides) on the developing brain, in children aged from 10 to 12 years.

Official Title
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Effect of Prenatal Exposure to Neurotoxicants on the Developing Brain: an MRI Study

Conditions
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Effects of Neurotoxicants on the Brain

Intervention / Treatment
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* Device: MRI
* Other: neuropsychological assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children included in the cohort PELAGIE Children participated in the study PEPSY Age between 10 and 12 years (pilot study) Exclusion Criteria: Maternal smoking and or alcohol consumption during pregnancy (study group) Children with a health event affecting neurodevelopment Children treated with methylphenidate, psychotropic or anti-epileptics

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: study group (cohort PELAGIE)<br>100 children included in the cohort PELAGIE | Device: MRI<br> <br> Other: neuropsychological assessment<br> <br> |
| Experimental: pilot group (no cohort PELAGIE)<br>10 children not included in the PELAGIE cohort to optimise MRI | Device: MRI<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the brain activity and its functionality | Measurement of the fractional anisotropy of the regions of interest on MRI : - with DTI (Diffusion Tensor Imaging) : DTI can be used to generate quantitative maps of the scalar (anisotropy, based on measurements of FA and mean diffusivity (MD)) or tensor (diffusivity expressed in the form of a 3x3 matrix) type. An intergroup analysis will be carried out to identify regions with FA and MD values different between exposed and non-exposed subjects. Tractography of the fibre bundles in the white matter could also be carried out, based on regions of interest extracted, for example, from high resolution morphometry or functional activation maps. The connectivity between these different regions may also be studied. | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of the brain activity and its functionality | Measurement of the cerebral blood flow and the activation of the regions of interest on MRI with : BOLD-fMRI (Blood Oxygen Level Dependent) : detection of the voxels activated, for each child, during the tasks (motor inhibition (Go / No-Go), attention (Posner's task) and working memory (N-back)) and comparison of levels of brain activation between exposure groups ASL (Arterial Spin Labeling) : quantitative value for cerebral blood flow | day 1 | 
| Results of neuropsychological tests | Correlation between the results of neuropsychological tests (subtests of the NEPSY (developmental NEuroPSYchological assessment) and the WISC-IV (Wechsler Intelligence Scale for Children version IV) tests that will evaluate motor inhibition, attention, working memory and graphomotor capacities) and MRI measurement | day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neurotoxicants, MRI, developing brain