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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02125110
Acronym
PERINE
Enrollment
112
Registered
2014-04-29
Start date
2014-04-30
Completion date
2017-10-31
Last updated
2023-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Effects of Neurotoxicants on the Brain

Keywords

neurotoxicants, MRI, developing brain

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.

Interventions

DEVICEMRI
OTHERneuropsychological assessment

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to 12 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Measurement of the brain activity and its functionalityday 1Measurement 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

MeasureTime frameDescription
Measurement of the brain activity and its functionalityday 1Measurement 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 testsday 1Correlation 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026