Regulatory Considerations for the Clinical and Research Use of Transcranial Direct Current Stimulation (tDCS): review and recommendations from an expert panel.
Regulatory Considerations for the Clinical and Research Use of Transcranial Direct Current Stimulation (tDCS): review and recommendations from an expert panel.
复制标题
DOI：
10.3109/10601333.2015.980944
复制
发表时间：
2015-03-01
期刊：
影响因子：
--
通讯作者：
Bikson M
中科院分区：
文献类型：
--
作者：
Fregni F;Nitsche MA;Loo CK;Brunoni AR;Marangolo P;Leite J;Carvalho S;Bolognini N;Caumo W;Paik NJ;Simis M;Ueda K;Ekhitari H;Luu P;Tucker DM;Tyler WJ;Brunelin J;Datta A;Juan CH;Venkatasubramanian G;Boggio PS;Bikson M
经颅电刺激(TES)领域在过去的15年中经历了显著的增长。导致这种兴趣增加的TES技术之一是经颅直流电刺激(TDC)。已有大量研究致力于确定tdcs在人类中的临床潜力。尽管tDCs在基础和临床神经科学方面取得了令人振奋的成果，但由于国际调控途径缺乏明确性，进一步的进展受到阻碍。因此，我们召集了一个关于tdcs的研究和临床专家小组，以审查tdcs的研究和临床应用。在这份报告中，我们回顾了tdcs的监管现状，并根据以下国家对tdcs的研究、标签外和同情使用情况总结了结果：澳大利亚、巴西、法国、德国、印度、伊朗、意大利、葡萄牙、韩国、台湾和美国。在这项研究中回顾的大多数国家都使用了tdcs的研究用途、标签外治疗和同情使用。在充分的随机对照试验的基础上，组织全球性或地区性的努力，寻求明确的证据，以批准、规范或限制tDCs在临床实践中的使用，这一点至关重要。
The field of transcranial electrical stimulation (tES) has experienced significant growth in the past 15 years. One of the tES techniques leading this increased interest is transcranial direct current stimulation (tDCS). Significant research efforts have been devoted to determining the clinical potential of tDCS in humans. Despite the promising results obtained with tDCS in basic and clinical neuroscience, further progress has been impeded by a lack of clarity on international regulatory pathways. We therefore convened a group of research and clinician experts on tDCS to review the research and clinical use of tDCS. In this report, we review the regulatory status of tDCS, and we summarize the results according to research, off-label and compassionate use of tDCS in the following countries: Australia, Brazil, France, Germany, India, Iran, Italy, Portugal, South Korea, Taiwan and United States. Research use, off label treatment and compassionate use of tDCS are employed in most of the countries reviewed in this study. It is critical that a global or local effort is organized to pursue definite evidence to either approve and regulate or restrict the use of tDCS in clinical practice on the basis of adequate randomized controlled treatment trials.