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多疗程经颅直流电刺激对精神分裂症社会认知的疗效和安全性:一项开放标签单臂试验的研究方案

Efficacy and Safety of Multi-Session Transcranial Direct Current Stimulation on Social Cognition in Schizophrenia: A Study Protocol for an Open-Label, Single-Arm Trial.

作者信息

Yamada Yuji, Inagawa Takuma, Yokoi Yuma, Shirama Aya, Sueyoshi Kazuki, Wada Ayumu, Hirabayashi Naotsugu, Oi Hideki, Sumiyoshi Tomiki

机构信息

National Center of Neurology and Psychiatry, Department of Psychiatry, National Center Hospital, 4-1-1 Ogawahigashi-cho, Kodaira, Tokyo 187-8551, Japan.

National Center of Neurology and Psychiatry, Department of Preventive Intervention for Psychiatric Disorders, National Institute of Mental Health, 4-1-1 Ogawahigashi-cho, Kodaira, Tokyo 187-8551, Japan.

出版信息

J Pers Med. 2021 Apr 19;11(4):317. doi: 10.3390/jpm11040317.

DOI:10.3390/jpm11040317
PMID:33921706
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8073289/
Abstract

BACKGROUNDS

Social cognition is defined as the mental operations underlying social behavior. Patients with schizophrenia elicit impairments of social cognition, which is linked to poor real-world functional outcomes. In a previous study, transcranial direct current stimulation (tDCS) improved emotional recognition, a domain of social cognition, in patients with schizophrenia. However, since social cognition was only minimally improved by tDCS when administered on frontal brain areas, investigations on the effect of tDCS on other cortical sites more directly related to social cognition are needed. Therefore, we present a study protocol to determine whether multi-session tDCS on superior temporal sulcus (STS) would improve social cognition deficits of schizophrenia.

METHODS

This is an open-label, single-arm trial, whose objective is to investigate the efficacy and safety of multi-session tDCS over the left STS to improve social cognition in patients with schizophrenia. The primary outcome measure will be the Social Cognition Screening Questionnaire. Neurocognition, functional capacity, and psychotic symptoms will also be evaluated by the Brief Assessment of Cognition in Schizophrenia, UCSD Performance-Based Skills Assessment-Brief, and Positive and Negative Syndrome Scale, respectively. Data will be collected at baseline, and 4 weeks after the end of intervention. If social cognition is improved in patients with schizophrenia by tDCS based on this protocol, we may plan randomized controlled trial.

摘要

背景

社会认知被定义为社会行为背后的心理操作。精神分裂症患者存在社会认知障碍,这与现实世界中的不良功能结局相关。在先前的一项研究中,经颅直流电刺激(tDCS)改善了精神分裂症患者的情绪识别能力,情绪识别是社会认知的一个领域。然而,由于在额叶脑区进行tDCS时,社会认知仅得到了最小程度的改善,因此需要研究tDCS对与社会认知更直接相关的其他皮质部位的影响。因此,我们提出一项研究方案,以确定对颞上沟(STS)进行多疗程tDCS是否会改善精神分裂症患者的社会认知缺陷。

方法

这是一项开放标签、单臂试验,其目的是研究对左侧STS进行多疗程tDCS改善精神分裂症患者社会认知的疗效和安全性。主要结局指标将是社会认知筛查问卷。神经认知、功能能力和精神病性症状也将分别通过精神分裂症认知简要评估、基于加州大学圣地亚哥分校表现的技能评估简表以及阳性和阴性症状量表进行评估。数据将在基线时以及干预结束后4周收集。如果根据本方案tDCS能改善精神分裂症患者的社会认知,我们可能会计划进行随机对照试验。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c33c/8073289/8999420bbf0e/jpm-11-00317-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c33c/8073289/1cd1aace73b7/jpm-11-00317-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c33c/8073289/8999420bbf0e/jpm-11-00317-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c33c/8073289/1cd1aace73b7/jpm-11-00317-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c33c/8073289/8999420bbf0e/jpm-11-00317-g002.jpg

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