Evaluation of Brain Plasticity in Premature Infants at School Age After Cognitive
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Activation of cortical areas
研究概览
简要总结
Infantile brain plasticity is still a poorly known phenomenon. However, neuropsychological disorders and behavioral deficits are common disorders that can have serious consequences for school enrollment, family and social adjustment, as well as repercussions on future adult lives.
In addition, generally very premature infants (TGP) have identifiable executive function disorders (EF), particularly those involving attentional processes such as working memory (WM).
The main objective of the study is to evaluate the effects of cognitive remediation (CR) strategies on the brain plasticity of the cortical areas involved in the management of WM in school-aged TGP children (8 years).
The secondary objective of the study is to evaluate the action of CR on the development of cortical areas concerned
It is a monocentric, prospective and comparative study of the exposed type (to cognitive remediation) - unexposed. Recruitment and data collection are carried out prospectively, in connection with the original study (EPIREMED). Included patients will be explored by Magnetic Resonance Imaging (MRI) 3 resting state Tesla.
The main hypothesis is that CR strategies have a beneficial effect on the cognitive processing of visual-spatial executive functions, but also on the cortical areas involved in brain plasticity in general (indirect benefits); not to mention the psychological benefits ad hoc to such studies (self-esteem, increased concentration, new stress management strategies put in place).
The ultimate objective of this study is to better understand the mechanisms of cerebral plasticity concerning higher executive functions. Moreover, this study should make it possible to confirm the improvement of the overall fate of the child by better understanding the neuropsychological and anatomical origins of his disorders. Interventions taking into account the environment of the very premature baby are necessary because it is closely linked to the developmental future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children born between 24 and 34 weeks of amenorrhea and living in the Provence region
- •Possessing an intelligence quotient (IQ) greater than 70
排除标准
- •Child not understanding French
- •Child who did not have all the interventions in the EPIREMED study
研究组 & 干预措施
Group exposed to cognitive remediation
Computerized cognitive remediation program. Program performed during inclusion in the EPIREMED patient study (Clinical trial number NCT02757794)
干预措施: Magnetic Resonance Imaging (MRI) 3 tesla (Device)
Group not exposed to cognitive remediation
Standard remediation performed during inclusion in the EPIREMED patient study (Clinical trial number NCT02757794)
干预措施: Magnetic Resonance Imaging (MRI) 3 tesla (Device)
结局指标
主要结局
Activation of cortical areas
时间窗: 24 months
Hyper activation on the Magnetic Resonance Imaging (MRI) associated with working memory
次要结局
未报告次要终点