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临床试验/NCT05269927
NCT05269927已完成不适用

A Multi-domain Approach for the Characterization and Early Diagnosis of Neurodevelopmental Disorders

IRCCS Eugenio Medea2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2016年3月1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
300
试验地点
2
主要终点
EEG power spectral density (PSD)

研究概览

简要总结

Diagnosis and characterization of neurodevelopmental disorders are considered challenging processes because of their complexity, multi-factoriality and heterogeneity. The present project will consider two of the most common neurodevelopmental disorders (i.e. autism spectrum disorders (ASD) and language disorders (LD)), with the aim to overcome these difficulties, by: a) deeply investigating their neuronal correlates; b) identifying multi-domain biomarkers (electrophysiological, genetic, environmental and clinical); c) developing a machine learning algorithm for early diagnosis. To achieve the above mentioned aims a multi-domain dataset will be used, comprising data collected from typically developing infants, infants at high risk for ASD and infants at high risk for LD. The data that will be used have been already collected within other trials performed at the Scientific Institute E. Medea.

研究设计

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

入排标准

年龄范围
5 Months 至 7 Months(Child)
性别
All
接受健康志愿者

入选标准

  • APGAR scores at birth at 1' and 5' > 7;
  • newborn screening otoacoustic emissions in the norm;
  • absence of neurological disorders;
  • Italian as the language mainly spoken in the family nucleus.

排除标准

  • APGAR scores at birth at 1' and 5' <= 7;
  • newborn screening otoacoustic emissions not in the norm;
  • presence of neurological disorders;
  • non-Italian native speaker

结局指标

主要结局

EEG power spectral density (PSD)

时间窗: one year after the end of the recruitment

Power spectral density (PSD) estimated in the delta, theta, alpha, beta and gamma frequency bands of the EEG

EEG signal entropy

时间窗: 18 months after the end of the recruitment

EEG signal entropy

EEG signal coherence

时间窗: 18 months after the end of the recruitment

EEG signal coherence

次要结局

未报告次要终点

研究者

发起方
IRCCS Eugenio Medea
申办方类型
Other
责任方
Sponsor

研究点 (2)

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