Ewen Joshua B, Sweeney John A, Potter William Z
Department of Neurology and Developmental Medicine, Kennedy Krieger Institute, Baltimore, MD, United States.
Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, United States.
Front Integr Neurosci. 2019 Aug 21;13:45. doi: 10.3389/fnint.2019.00045. eCollection 2019.
Biological treatment development for syndromal neuropsychiatric conditions such as autism has seen slow progress for decades. Speeding drug discovery may result from the judicious development and application of biomarker measures of brain function to select patients for clinical trials, to confirm target engagement and to optimize drug dose. For neurodevelopmental disorders, electrophysiology (EEG) offers considerable promise because of its ability to monitor brain activity with high temporal resolution and its more ready application for pediatric populations relative to MRI. Here, we discuss conceptual/definitional issues related to biomarker development, discuss practical implementation issues, and suggest preliminary guidelines for validating EEG approaches as biomarkers with a context of use in neurodevelopmental disorder drug development.
几十年来，针对自闭症等综合征性神经精神疾病的生物治疗进展缓慢。加速药物研发可能源于明智地开发和应用脑功能生物标志物测量方法，以选择临床试验患者、确认靶点参与情况并优化药物剂量。对于神经发育障碍，电生理学（脑电图，EEG）具有很大的前景，因为它能够以高时间分辨率监测脑活动，并且相对于磁共振成像（MRI）而言，更易于应用于儿科人群。在此，我们讨论与生物标志物开发相关的概念/定义问题，探讨实际实施问题，并提出在神经发育障碍药物研发背景下将脑电图方法验证为生物标志物的初步指南。
