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

Not Applicable

Completed

• Conditions: Effects of Neurotoxicants on the Brain
• Interventions: Device: MRI; Other: neuropsychological assessment

• Registration Number: NCT02125110
• Lead Sponsor: Rennes University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-22
• Study First Submitted QC: 2014-04-24
• Study First Posted: 2014-04-29
• Primary Completion: 2016-11
• Study Completion: 2017-10
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-22
• Last Update Posted: 2023-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pilot group (no cohort PELAGIE)	MRI	10 children not included in the PELAGIE cohort to optimise MRI
study group (cohort PELAGIE)	neuropsychological assessment	100 children included in the cohort PELAGIE
study group (cohort PELAGIE)	MRI	100 children included in the cohort PELAGIE

Primary Outcome Measures

Name	Time	Method
Measurement of the brain activity and its functionality	day 1	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.

Secondary Outcome Measures

Name	Time	Method
Measurement of the brain activity and its functionality	day 1	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
Results of neuropsychological tests	day 1	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

Trial Locations

Locations (1)

CHU Rennes; 🇫🇷 Rennes, France