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临床试验/NCT03084848
NCT03084848已完成不适用

Cerebral Bases of the Cognitive Learning in the Executive Control In the Adolescence

Centre Hospitalier St Anne4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年5月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
4
主要终点
Brain plasticity : Longitudinal cortical thickness change

研究概览

简要总结

The purpose of this study is to investigate the cognitive and brain effects of inhibitory control (IC) training at adolescence.

详细描述

Brain imaging now allows to study non-invasively cognitive learning processes. An area of strong scientific interest is the development of executive control, an essential cognitive domain for academic and professional success and for mental and physical health. These functions are essentially located within the prefrontal cortex, characterising by a late maturation until the end of adolescence and, while under genetic control, can likely be improved with targeted interventions. The objective of this project is simple and innovative: testing in adolescents with the most appropriate brain imaging technologies available today (the Magnetic Resonance Imaging, MRI), the effect of an executive training focused on the inhibitory control (IC). This project aims at precisely testing the effect at the cognitive and brain levels of IC training in adolescence. To do this, the investigators will recruit two groups of 30 teenagers aged 16 to 17 years old, each assigned to one of two learning situations: IC vs Active Control (AC). Each participant will participate in 25 training sessions of 15 minutes per day, 5 days a week for a month. Brain structural and functional differences in the brain and between the pre-test and post-test related to intense IC training will be correlated with cognitive progress.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
16 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 16-17 years old
  • girl or boy ;
  • French mother tongue;
  • Handedness: Right;
  • Schooled in a level corresponding to its age (2nd or 1st)
  • Informed consent signed by the (s) holder (s) of parental authority, in agreement with the teenager
  • Normal medical, neurological, neuroradiological examinations.
  • Health insurance

排除标准

  • classical exclusion criteria for MRI
  • Has chronic use of alcohol or drugs;
  • Abuse or substance dependence (excluding nicotine) or a toxic over 5 years or has led to comas (overdoses)
  • Cognitive disorders of sudden onset that may reflect a stroke; history of head trauma with loss of consciousness for more than 1 hour, or encephalitis;
  • A chronic neurological disorder, psychiatric, endocrine, hepatic and infectious disorder;
  • Major disease history (diabetes, chronic lung disease, heart disorder, metabolic, hematologic, endocrine or immunological severe cancer);
  • A medication that may interfere with brain imaging measures (psychotropic drugs, hypnotics, anxiolytics, antipsychotics, anti-Parkinson, benzodiazepines, anti-inflammatory drugs, antiepileptics, antihistamines, analgesics and muscle relaxants central);
  • dyschromatopsia
  • Impossibility to submit itself to the study for geographical or psychiatric reasons;
  • Pregnant and lactating women;
  • Has pervasive developmental disorders and / or acquisitions identified by parents or legal guardian and (or) the teachers;
  • Cerebral palsy;
  • Fine motor disorder
  • Unaccompanied by parent (s) (s) or at least a person with parental authority during the visit to the research platform;
  • Tattoo on the head, neck or shoulders

结局指标

主要结局

Brain plasticity : Longitudinal cortical thickness change

时间窗: one month IC training

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier St Anne
申办方类型
Other
责任方
Sponsor

研究点 (4)

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