PDF(Pubmed)
Abstract：
The application of transcranial direct current stimulation (tDCS) at home for the treatment of major depressive disorder (MDD) is the subject of current clinical trials. This is due to its positive safety profile, cost-effectiveness, and potential scalability for a wide outreach in clinical practice. Here, we provide a systematic review of the available studies and also a report on the results of a randomized controlled trial (RCT) on tDCS at home for the treatment of MDD. This trial had to be prematurely terminated due to safety concerns. The HomeDC trial is a double-blinded, placebo-controlled, parallel-group study. Patients with MDD (DSM-5) were randomized to active or sham tDCS. Patients conducted tDCS at home for 6 weeks with 5 sessions/week (30 min at 2 mA) anode over F3, cathode over F4. Sham tDCS resembled active tDCS, with ramp-in and ramp-out periods, but without intermittent stimulation. The study was prematurely terminated due to an accumulation of adverse events (AEs, skin lesions), so that only 11 patients were included. Feasibility was good. Safety monitoring was not sufficient enough to detect or prevent AEs within an appropriate timeframe. Regarding antidepressant effects, the reduction in depression scales over time was significant. However, active tDCS was not superior to sham tDCS in this regard. Both the conclusions from this review and the HomeDC trial show that there are several critical issues with the use of tDCS at home that need to be addressed. Nevertheless the array of transcranial electric simulation (TES) methods that this mode of application offers, including tDCS, is highly interesting and warrants further investigation in high quality RCTs.
BACKGROUND: www.
RESULTS: gov .
BACKGROUND: NCT05172505. Registration date: 12/13/2021, https://clinicaltrials.gov/ct2/show/NCT05172505 . *Consider, if feasible to do so, reporting the number of records identified from each database or register searched (rather than the total number across all databases/registers) **If automation tools were used, indicate how many records were excluded by a human and how many were excluded by automation tools From: Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021;372:n71. https://doi.org/10.1136/bmj.n71 . For more information, visit: http://www.prisma-statement.org/.
BACKGROUND: www.
RESULTS: gov .
BACKGROUND: NCT05172505. Registration date: 12/13/2021, https://clinicaltrials.gov/ct2/show/NCT05172505 . *Consider, if feasible to do so, reporting the number of records identified from each database or register searched (rather than the total number across all databases/registers) **If automation tools were used, indicate how many records were excluded by a human and how many were excluded by automation tools From: Page MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021;372:n71. https://doi.org/10.1136/bmj.n71 . For more information, visit: http://www.prisma-statement.org/.
摘要：
在家中应用经颅直流电刺激（tDCS）治疗重度抑郁症（MDD）是当前临床试验的主题。这是由于其积极的安全性，成本效益，以及在临床实践中广泛推广的潜在可扩展性。这里,我们对现有的研究进行了系统综述,并对一项关于tDCS在家中治疗MDD的随机对照试验(RCT)的结果进行了报道.出于安全考虑，该试验不得不提前终止。HomeDC试验是双盲的,安慰剂对照,平行组研究。MDD（DSM-5）患者被随机分为活动或假tDCS。患者在家中进行tDCS6周,每周5次(在2mA下30分钟)阳极在F3上,阴极在F4上。假tDCS类似于活动tDCS，有流入和流出期，但没有间歇性刺激。由于不良事件的累积，该研究提前终止(AEs，皮肤损伤)，所以只有11名患者被包括在内。可行性很好。安全性监测不足以在适当的时间范围内检测或预防AE。关于抗抑郁作用，随着时间的推移,抑郁量表显著减少.然而,在这方面，主动tDCS并不优于假tDCS。本评论和HomeDC试验的结论都表明，在家中使用tDCS存在一些关键问题，需要解决。尽管如此，这种应用模式提供的一系列经颅电模拟（TES）方法，包括tDCS，非常有趣，值得在高质量的随机对照试验中进一步研究。
背景：www.
结果：政府。
背景：NCT05172505。注册日期：12/13/2021，https://clinicaltrials.gov/ct2/show/NCT05172505。*考虑，如果可行的话，报告从搜索的每个数据库或寄存器中识别的记录数（而不是所有数据库/寄存器的总数）**如果使用自动化工具，指示人类排除了多少条记录以及自动化工具排除了多少条记录来自：页面MJ,McKenzieJE,博苏伊特总理，BoutronI,霍夫曼TC,MulrowCD,etal.PRISMA2020声明：报告系统评价的更新指南。英国医学杂志2021年；372:n71。https://doi.org/10.1136/bmj.N71.有关更多信息，访问:http://www。prisma-statement.org/.
背景：www.
结果：政府。
背景：NCT05172505。注册日期：12/13/2021，https://clinicaltrials.gov/ct2/show/NCT05172505。*考虑，如果可行的话，报告从搜索的每个数据库或寄存器中识别的记录数（而不是所有数据库/寄存器的总数）**如果使用自动化工具，指示人类排除了多少条记录以及自动化工具排除了多少条记录来自：页面MJ,McKenzieJE,博苏伊特总理，BoutronI,霍夫曼TC,MulrowCD,etal.PRISMA2020声明：报告系统评价的更新指南。英国医学杂志2021年；372:n71。https://doi.org/10.1136/bmj.N71.有关更多信息，访问:http://www。prisma-statement.org/.
