Department of Psychiatry and Division of Medical Psychology, University Hospital Bonn, Bonn, Germany.
Faculty of Medicine, School of Public Health, Department of Epidemiology and Biostatistics, Imperial College London, London, UK.
BMJ Open. 2019 Feb 19;9(2):e023796. doi: 10.1136/bmjopen-2018-023796.
Non-surgical brain stimulation techniques may be considered as alternative or add-on treatments for patients with major depressive disorder who failed to respond to pharmacological interventions. Electroconvulsive therapy has been shown to be highly effective in reducing depressive symptoms but stakeholders remain concerned about adverse cognitive effects. Repetitive transcranial magnetic stimulation and transcranial direct current stimulation may be associated with more benign adverse effect profiles and may indeed improve certain cognitive functions such as memory and attention. To guide clinical decision-making, we will carry out a systematic review and meta-analysis of the cognitive effects of eight non-surgical brain stimulation techniques.
A systematic literature search of the Embase, PubMed/MEDLINE and PsycINFO databases, the Cochrane Central Register of Controlled Trials, ClinicalTrials.gov and OpenGrey will be performed. We will include both randomised clinical trials which report on at least one cognitive measure post treatment as well as non-randomised trials and pre-post intervention studies. There are no restrictions to the type of cognitive outcome measures, except that the tests are standardised and psychometrically validated. The Revised Cochrane tool for assessing risk of bias in randomised trials (RoB 2.0) will be used to evaluate included trials. Pre-post studies will be evaluated using the quality assessment tool developed by the US National Heart, Lung and Blood Institute. Meta-analysis, meta-regression, subgroup and sensitivity analyses will be conducted where sufficient data are available.
No ethical approval is needed to conduct this work. The findings will be submitted for publication in peer-reviewed journals and presented at scientific meetings.
CRD42018118850.
对于那些对药物干预无反应的重度抑郁症患者,非手术性脑刺激技术可被视为替代或附加治疗方法。电惊厥疗法已被证明在减轻抑郁症状方面非常有效,但利益相关者仍对认知不良影响感到担忧。重复经颅磁刺激和经颅直流电刺激可能与更良性的不良影响特征相关,并且实际上可能改善某些认知功能,如记忆和注意力。为了指导临床决策,我们将对八种非手术性脑刺激技术的认知效果进行系统评价和荟萃分析。
我们将对 Embase、PubMed/MEDLINE 和 PsycINFO 数据库、Cochrane 对照试验中心注册库、ClinicalTrials.gov 和 OpenGrey 进行系统文献检索。我们将包括报告至少一种治疗后认知测量的随机临床试验,以及非随机试验和前后干预研究。认知结果测量的类型不受限制,除非测试是标准化的和心理测量验证的。将使用修订后的 Cochrane 随机试验偏倚评估工具(RoB 2.0)来评估纳入的试验。对于前后研究,将使用美国国家心脏、肺和血液研究所开发的质量评估工具进行评估。如果有足够的数据,将进行荟萃分析、荟萃回归、亚组和敏感性分析。
进行这项工作不需要伦理批准。研究结果将提交给同行评议期刊发表,并在科学会议上展示。
PROSPERO 注册号:CRD42018118850。