Department of Scienze Mediche, Chirurgiche e Neuroscienze, Unit of Neurology and Clinical Neurophysiology, Brain Investigation and Neuromodulation Lab (SI-BIN Lab), University of Siena, Italy.
Department of Clinical Neurophysiology, University Medical Center, Georg-August University of Goettingen, Germany; Institue of Medical Psychology, Otto-Guericke University Magdeburg, Germany.
Clin Neurophysiol. 2021 Jan;132(1):269-306. doi: 10.1016/j.clinph.2020.10.003. Epub 2020 Oct 24.
This article is based on a consensus conference, promoted and supported by the International Federation of Clinical Neurophysiology (IFCN), which took place in Siena (Italy) in October 2018. The meeting intended to update the ten-year-old safety guidelines for the application of transcranial magnetic stimulation (TMS) in research and clinical settings (Rossi et al., 2009). Therefore, only emerging and new issues are covered in detail, leaving still valid the 2009 recommendations regarding the description of conventional or patterned TMS protocols, the screening of subjects/patients, the need of neurophysiological monitoring for new protocols, the utilization of reference thresholds of stimulation, the managing of seizures and the list of minor side effects. New issues discussed in detail from the meeting up to April 2020 are safety issues of recently developed stimulation devices and pulse configurations; duties and responsibility of device makers; novel scenarios of TMS applications such as in the neuroimaging context or imaging-guided and robot-guided TMS; TMS interleaved with transcranial electrical stimulation; safety during paired associative stimulation interventions; and risks of using TMS to induce therapeutic seizures (magnetic seizure therapy). An update on the possible induction of seizures, theoretically the most serious risk of TMS, is provided. It has become apparent that such a risk is low, even in patients taking drugs acting on the central nervous system, at least with the use of traditional stimulation parameters and focal coils for which large data sets are available. Finally, new operational guidelines are provided for safety in planning future trials based on traditional and patterned TMS protocols, as well as a summary of the minimal training requirements for operators, and a note on ethics of neuroenhancement.
本文基于国际临床神经生理学联合会(IFCN)于 2018 年 10 月在意大利锡耶纳举行的共识会议。会议旨在更新十年前的经颅磁刺激(TMS)在研究和临床环境中应用的安全指南(Rossi 等人,2009 年)。因此,仅详细介绍新出现的问题,对于常规或模式 TMS 方案的描述、对象/患者的筛选、新方案的神经生理监测需求、刺激参考阈值的利用、癫痫发作的管理以及较小的副作用列表,仍然有效。会议上详细讨论了 2020 年 4 月之前的新问题,包括新开发的刺激设备和脉冲配置的安全问题;设备制造商的职责和责任;TMS 在神经影像学环境或影像引导和机器人引导 TMS 等新场景中的应用;TMS 与经颅电刺激的联合应用;配对联想刺激干预期间的安全性;以及使用 TMS 诱导治疗性癫痫发作(磁刺激治疗)的风险。提供了对 TMS 可能引起癫痫发作(理论上是 TMS 最严重的风险)的最新情况。很明显,即使在服用作用于中枢神经系统的药物的患者中,这种风险也很低,至少在使用传统刺激参数和用于大型数据集的焦点线圈的情况下。最后,根据传统和模式 TMS 方案,为规划未来试验的安全性提供了新的操作指南,以及对操作人员最低培训要求的总结,以及关于神经增强的伦理说明。
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