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