Clinical research with transcranial direct current stimulation (tDCS): challenges and future directions.
Clinical research with transcranial direct current stimulation (tDCS): challenges and future directions.
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DOI：
10.1016/j.brs.2011.03.002
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发表时间：
2012-07
影响因子：
7.7
通讯作者：
Fregni, Felipe
中科院分区：
文献类型：
--
作者：
Brunoni, Andre Russowsky;Nitsche, Michael A.;Bolognini, Nadia;Bikson, Marom;Wagner, Tim;Merabet, Lotfi;Edwards, Dylan J.;Valero-Cabre, Antoni;Rotenberg, Alexander;Pascual-Leone, Alvaro;Ferrucci, Roberta;Priori, Alberto;Boggio, Paulo Sergio;Fregni, Felipe
关键词：
经颅直流电刺激（tDCS）是一种神经调节技术，可向皮质区域提供低强度直流电，促进或抑制自发神经元活动。在过去的十年中，tDCS的生理作用机制已被深入研究，为研究其在临床神经精神病学和康复中的应用提供了支持。然而，当将临床前和I期研究的结果转化为II期和III期临床研究时，出现了新的方法学、伦理学和监管问题。这一全面审查的目的是讨论这一进程的主要挑战和应对这些挑战的可能方法。我们召集了该领域的一系列研究人员，审查、讨论并提供神经调节用于临床研究的最新情况和关键挑战。我们回顾了该领域的几项基础和临床研究，并考虑到该技术的特殊性，确定了潜在的局限性。我们回顾并讨论了四个主题的研究结果：（i）tDCS的作用机制，使用参数和基于计算机的人脑建模，研究tDCS诱导的电流场和幅度;（ii）与tDCS临床研究相关的方法学方面，根据研究阶段划分（即，临床前、I期、II期和III期研究）;（iii）伦理和监管问题;（iv）关于新方法、新器械和涉及tDCS的未来研究的未来方向。最后，我们提出了一些替代方法，以促进tDCS的临床研究。
Transcranial direct current stimulation (tDCS) is a neuromodulatory technique that delivers low-intensity, direct current to cortical areas facilitating or inhibiting spontaneous neuronal activity. In the past ten years, tDCS physiological mechanisms of action have been intensively investigated giving support for the investigation of its applications in clinical neuropsychiatry and rehabilitation. However, new methodological, ethical, and regulatory issues emerge when translating the findings of preclinical and phase I studies into phase II and III clinical studies. The aim of this comprehensive review is to discuss the key challenges of this process and possible methods to address them. We convened a workgroup of researchers in the field to review, discuss and provide updates and key challenges of neuromodulation use for clinical research. We reviewed several basic and clinical studies in the field and identified potential limitations, taking into account the particularities of the technique. We review and discuss the findings into four topics: (i) mechanisms of action of tDCS, parameters of use and computer-based human brain modeling investigating electric current fields and magnitude induced by tDCS; (ii) methodological aspects related to the clinical research of tDCS as divided according to study phase (i.e., preclinical, phase I, phase II and phase III studies); (iii) ethical and regulatory concerns; (iv) future directions regarding novel approaches, novel devices, and future studies involving tDCS. Finally, we propose some alternative methods to facilitate clinical research on tDCS.
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影响因子：
3.4
作者：
Boros, Klara;Poreisz, Csaba;Nitsche, Michael A.
通讯作者：
Nitsche, Michael A.
影响因子：
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Bajwa, Sami;Bermpohl, Felix;Fregni, Felipe
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影响因子：
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Fregni, Felipe
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通讯作者：
Fregni, Felipe
影响因子：
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作者：
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通讯作者：
Vallar, Giuseppe