Effect of Prenatal Exposure to Neurotoxicants on the Developing Brain: an MRI Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Measurement of the brain activity and its functionality
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children included in the cohort PELAGIE
- •Children participated in the study PEPSY
- •Age between 10 and 12 years (pilot study)
排除标准
- •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
结局指标
主要结局
Measurement of the brain activity and its functionality
时间窗: 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.
次要结局
- Measurement of the brain activity and its functionality(day 1)
- Results of neuropsychological tests(day 1)