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

May 22, 2023 updated by: Rennes University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France
        • CHU Rennes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
day 1
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
day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2014

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

April 22, 2014

First Submitted That Met QC Criteria

April 24, 2014

First Posted (Estimate)

April 29, 2014

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2013-A01420-45

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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