Narita Zui, Inagawa Takuma, Maruo Kazushi, Sueyoshi Kazuki, Sumiyoshi Tomiki
Department of Psychiatry, National Center Hospital, National Center of Neurology and Psychiatry, Tokyo, Japan.
Department of Clinical Epidemiology, Translational Medical Center, National Center of Neurology and Psychiatry, Tokyo, Japan.
Front Psychiatry. 2017 Nov 13;8:233. doi: 10.3389/fpsyt.2017.00233. eCollection 2017.
Schizophrenia patients elicit a wide range of psychopathology, including psychotic symptoms, mood symptoms, and cognitive impairment. Functional capacity is defined as the ability to perform everyday living skills, which is linked to cognition and real-world functional outcome. In a previous open trial, we demonstrated that transcranial direct current stimulation (tDCS), one of the neuromodulation methods, improved cognition and functional capacity in 28 patients with schizophrenia. However, since it was a pilot study, a controlled trial is needed. Therefore, we present a study protocol for a randomized controlled trial designed to evaluate the effect of tDCS on functional capacity in patients with schizophrenia. This is a two-arm, parallel-design, randomized controlled trial, in which patients and assessors will be blinded. Patients meeting DSM-5 criteria for schizophrenia will be enrolled and randomized to receive either active or sham stimulation (with 10 sessions in five consecutive days). Functional capacity will be evaluated by the UCSD Performance-based Skills Assessment-Brief as primary outcome. Cognition, as measured by the Brief Assessment of Cognition in Schizophrenia, and psychotic symptoms, as measured by the Positive and Negative Syndrome Scale, will also be evaluated. Data will be collected at baseline, immediately after the last stimulation, and 1 and 2 months thereafter. If active stimulation elicits greater effects compared with those of sham stimulation, it may add to the efforts to improve functional outcomes by neuromodulation in patients with schizophrenia.
UMIN000028224; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000032305.
精神分裂症患者会出现广泛的精神病理学症状，包括精神病性症状、情绪症状和认知障碍。功能能力被定义为执行日常生活技能的能力，这与认知和现实世界的功能结局相关。在之前的一项开放性试验中，我们证明了经颅直流电刺激（tDCS）作为一种神经调节方法，改善了28例精神分裂症患者的认知和功能能力。然而，由于这是一项初步研究，需要进行对照试验。因此，我们提出一项随机对照试验的研究方案，旨在评估tDCS对精神分裂症患者功能能力的影响。这是一项双臂、平行设计的随机对照试验，患者和评估者将被设盲。符合精神分裂症DSM-5标准的患者将被纳入并随机分组，接受主动刺激或假刺激（连续五天进行10次治疗）。功能能力将通过基于表现的加州大学圣地亚哥分校技能评估简表作为主要结局进行评估。还将评估通过精神分裂症认知简短评估所测量的认知以及通过阳性和阴性症状量表所测量的精神病性症状。数据将在基线、最后一次刺激后立即以及此后1个月和2个月收集。如果主动刺激比假刺激产生更大的效果，这可能会增加通过神经调节改善精神分裂症患者功能结局的努力。
UMIN000028224；https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000032305
