METHODS: The study is designed as a randomized, double-blind, 2-arm parallel-group, sham-controlled, trial. Forty-eight participants with SCZ and cognitive impairment (measured via a set of executive functions tests) will be randomly allocated to receive either a single session of active (n = 24) or sham (n = 24) tDCS (20-min, 3-mA). The anodal and cathodal electrodes are positioned over the left and right DLPFC respectively. The stimulation occurs concurrently with the working memory task, which is initiated precisely 5 minutes after the onset of tDCS. Structural and resting-state (rs-fMRI) scans are conducted immediately before and after both active and sham tDCS using a 3 Tesla scanner (Siemens Prisma model) equipped with a 64-channel head coil. The primary outcome will be changes in brain activation (measures vis BOLD response) and working memory performance (accuracy, reaction time).
CONCLUSIONS: The results of this study are helpful in optimizing tDCS protocols in SCZ and inform us of neurocognitive mechanisms underlying 3 mA stimulation. This study will additionally provide initial safety and efficacy data on a 3 mA tDCS protocol to support larger clinical trials. Positive results could lead to rapid and broader testing of a promising tool for debilitating symptoms that affect the majority of patients with SCZ. The results will be made available through publications in peer-reviewed journals and presentations at national and international conferences.
方法:该研究设计为随机,双盲,双臂平行组,假控制,审判。将随机分配48名患有SCZ和认知障碍(通过一组执行功能测试进行测量)的参与者,以接受一次活动(n=24)或假(n=24)tDCS(20分钟,3-mA)。阳极电极和阴极电极分别位于左DLPFC和右DLPFC上方。刺激与工作记忆任务同时发生,它在tDCS发作后精确地5分钟开始。使用配备有64通道头部线圈的3特斯拉扫描仪(西门子Prisma型号),在活动和假tDCS之前和之后立即进行结构和静息状态(rs-fMRI)扫描。主要结果将是大脑激活(测量与BOLD反应)和工作记忆表现(准确性,反应时间)。
结论:这项研究的结果有助于优化SCZ中的tDCS方案,并告知我们3mA刺激的神经认知机制。本研究还将提供3mAtDCS协议的初始安全性和有效性数据,以支持更大的临床试验。阳性结果可能导致对影响大多数SCZ患者的衰弱症状的有希望的工具进行快速和更广泛的测试。结果将通过同行评审期刊上的出版物以及在国家和国际会议上的演讲提供。