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Completed

NCT Number: NCT02125110

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

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.

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Key information

Conditions

Effects of Neurotoxicants on the Brain

Age range

10 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Rennes

Rennes, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Device

Neuropsychological assessment

Other

Primary outcomes

  1. Measurement of the brain activity and its functionality

    Time frame: 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 outcomes

  1. Measurement of the brain activity and its functionality

    Time frame: 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

  2. Results of neuropsychological tests

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

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

Acronym: PERINE

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Apr 29, 2014
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.