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

Rennes University Hospital112 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

112

Conditions

Effects of Neurotoxicants on the Brain

Interventions

MRIDEVICE

neuropsychological assessmentOTHER

Eligibility

Sex: ALLMin age: 10 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

CHU Rennes

Rennes, France

Outcomes

Primary Outcomes

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.

Time frame: day 1

Secondary Outcomes

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

Time frame: 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

Time frame: day 1

Data from ClinicalTrials.gov

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