Effects of Neurotoxicants on the BrainPERINENCT02125110
PERINE : Effect of Prenatal Exposure to Neurotoxicants on the Developing Brain : an MRI Study
A study testing MRI and neuropsychological assessment in people with Effects of Neurotoxicants on the Brain, run by Rennes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Effects of Neurotoxicants on the Brain
- What is being tested?
- MRI and neuropsychological assessment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children included in the cohort PELAGIE
- Children participated in the study PEPSY
- Age between 10 and 12 years (pilot study)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Effects of Neurotoxicants on the Brain
- Being tested
- MRI, neuropsychological assessment
- Keywords
- neurotoxicants, MRI, developing brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
neuropsychological assessmentOther
| Study group | Role | What they receive |
|---|---|---|
| study group (cohort PELAGIE) | Experimental | 100 children included in the cohort PELAGIE Receives: Device: MRI; Other: neuropsychological assessment |
| pilot group (no cohort PELAGIE) | Experimental | 10 children not included in the PELAGIE cohort to optimise MRI Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 1
Secondary outcomes (2)
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
Measured: 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
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionNov 2016
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Effects of Neurotoxicants on the BrainStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02125110
- Sponsor's protocol ID
- 2013-A01420-45
- Acronym
- PERINE
- Status last verified
- May 2023
- First submitted
- 22 Apr 2014
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Binter AC, Bannier E, Simon G, Saint-Amour D, Ferre JC, Barillot C, Monfort C, Cordier S, Chevrier C, Pele F. Prenatal exposure to glycol ethers and motor inhibition function evaluated by functional MRI at the age of 10 to 12 years in the PELAGIE mother-child cohort. Environ Int. 2019 Dec;133(Pt A):105163. doi: 10.1016/j.envint.2019.105163. Epub 2019 Sep 11.
PubMed 31518935
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prenatal Exposure to Neurotoxicants on the Developing Brain: an MRI Study
- ClinicalTrials.gov ID
- NCT02125110
- Acronym / sponsor ID
- PERINE / 2013-A01420-45
- Conditions
- Effects of Neurotoxicants on the Brain
- Keywords
- neurotoxicants, MRI, developing brain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 29 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group (cohort PELAGIE) | Experimental | Device: MRI, Other: neuropsychological assessment100 children included in the cohort PELAGIE |
| pilot group (no cohort PELAGIE) | Experimental | Device: MRI10 children not included in the PELAGIE cohort to optimise MRI |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children included in the cohort PELAGIE
- Children participated in the study PEPSY
- Age between 10 and 12 years (pilot study)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI | Device | pilot group (no cohort PELAGIE), study group (cohort PELAGIE) |
| neuropsychological assessment | Other | study group (cohort PELAGIE) |
Primary outcome
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.
2 secondary outcomes
Measurement of the brain activity and its functionality
Time frame: day 1
Results of neuropsychological tests
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Results publication: PubMed 31518935Binter AC, Bannier E, Simon G, Saint-Amour D, Ferre JC, Barillot C, Monfort C, Cordier S, Chevrier C, Pele F. Prenatal exposure to glycol ethers and motor inhibition function evaluated by functional MRI at the age of 10 to 12 years in the PELAGIE mother-child cohort. Environ Int. 2019 Dec;133(Pt A):105163. doi: 10.1016/j.envint.2019.105163. Epub 2019 Sep 11.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI and neuropsychological assessment in people with Effects of Neurotoxicants on the Brain, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the brain activity and its functionality (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02125110, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.