Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines,Clinical Neurophysiology

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Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines
Clinical Neurophysiology ( IF 4.7 ) Pub Date : 2021-01-01 , DOI: 10.1016/j.clinph.2020.10.003
Simone Rossi ₁ , Andrea Antal ₂ , Sven Bestmann ₃ , Marom Bikson ₄ , Carmen Brewer ₅ , Jürgen Brockmöller ₆ , Linda L Carpenter ₇ , Massimo Cincotta ₈ , Robert Chen ₉ , Jeff D Daskalakis ₁₀ , Vincenzo Di Lazzaro ₁₁ , Michael D Fox ₁₂ , Mark S George ₁₃ , Donald Gilbert ₁₄ , Vasilios K Kimiskidis ₁₅ , Giacomo Koch ₁₆ , Risto J Ilmoniemi ₁₇ , Jean Pascal Lefaucheur ₁₈ , Letizia Leocani ₁₉ , Sarah H Lisanby ₂₀ , Carlo Miniussi ₂₁ , Frank Padberg ₂₂ , Alvaro Pascual-Leone ₂₃ , Walter Paulus ₂₄ , Angel V Peterchev ₂₅ , Angelo Quartarone ₂₆ , Alexander Rotenberg ₂₇ , John Rothwell ₃ , Paolo M Rossini ₂₈ , Emiliano Santarnecchi ₂₉ , Mouhsin M Shafi ₂₉ , Hartwig R Siebner ₃₀ , Yoshikatzu Ugawa ₃₁ , Eric M Wassermann ₃₂ , Abraham Zangen ₃₃ , Ulf Ziemann ₃₄ , Mark Hallett ₃₅ ,

Affiliation

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.
Department of Movement and Clinical Neurosciences, UCL Queen Square Institute of Neurology, London, UK and Wellcome Centre for Human Neuroimaging, UCL Queen Square Institute of Neurology, London, UK.
Department of Biomedical Engineering, The City College of New York, New York, NY, USA.
National Institute on Deafness and Other Communication Disorders, National Institutes of Health (NIH), Bethesda, MD, USA.
Department of Clinical Pharmacology, University Medical Center, Georg-August University of Goettingen, Germany.
Butler Hospital, Brown University Department of Psychiatry and Human Behavior, Providence, RI, USA.
Unit of Neurology of Florence - Central Tuscany Local Health Authority, Florence, Italy.
Krembil Research Institute and Division of Neurology, Department of Medicine, University of Toronto, Canada.
Center for Addiction and Mental Health (CAMH), University of Toronto, Canada.
Unit of Neurology, Neurophysiology, Neurobiology, Department of Medicine, Università Campus Bio-Medico, Roma, Italy.
Berenson-Allen Center for Noninvasive Brain Stimulation, Department of Neurology, Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, MA, USA; Department of Neurology, Massachusetts General Hospital, Boston, MA, USA; Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Charlestown, MA, USA.
Medical University of South Carolina, Charleston, SC, USA.
Division of Neurology, Department of Pediatrics, Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, OH, USA.
Laboratory of Clinical Neurophysiology, Aristotle University of Thessaloniki, AHEPA University Hospital, Greece.
IRCCS Santa Lucia, Roma, Italy.
Department of Neuroscience and Biomedical Engineering (NBE), Aalto University School of Science, Aalto, Finland.
EA 4391, ENT Team, Faculty of Medicine, Paris Est Creteil University (UPEC), Créteil, France; Clinical Neurophysiology Unit, Henri Mondor Hospital, Assistance Publique Hôpitaux de Paris, (APHP), Créteil, France.
Department of Neurology, Institute of Experimental Neurology (INSPE), IRCCS-San Raffaele Hospital, Vita-Salute San Raffaele University, Milano, Italy.
National Institute of Mental Health (NIMH), National Institutes of Health (NIH), Bethesda, MD, USA; Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, USA.
Center for Mind/Brain Sciences - CIMeC, University of Trento, Rovereto, Italy.
Department of Psychiatry and Psychotherapy, University Hospital, LMU Munich, Munich, Germany.
Hinda and Arthur Marcus Institute for Aging Research and Center for Memory Health, Hebrew SeniorLife, USA; Department of Neurology, Harvard Medical School, Boston, MA, USA; Guttmann Brain Health Institut, Institut Guttmann, Universitat Autonoma Barcelona, Spain.
Department of Clinical Neurophysiology, University Medical Center, Georg-August University of Goettingen, Germany.
Departments of Psychiatry & Behavioral Sciences, Biomedical Engineering, Electrical & Computer Engineering, and Neurosurgery, Duke University, Durham, NC, USA.
Department of Biomedical, Dental Sciences and Morphological and Functional Images, University of Messina, Messina, Italy.
Department of Neurology, Division of Epilepsy and Clinical Neurophysiology, Children's Hospital, Harvard Medical School, Boston, MA, USA.
Department of Neuroscience and Rehabilitation, IRCCS San Raffaele-Pisana, Roma, Italy.
Berenson-Allen Center for Noninvasive Brain Stimulation, Department of Neurology, Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, MA, USA.
Danish Research Centre for Magnetic Resonance, Copenhagen University Hospital Hvidovre, Copenhagen, Denmark; Department of Neurology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark; Institute for Clinical Medicine, Faculty of Medical and Health Sciences, University of Copenhagen, Copenhagen, Denmark.
Department of Human Neurophysiology, School of Medicine, Fukushima Medical University, Fukushima, Japan.
National Institute of Neurological Disorders and Stroke, Bethesda, MD, USA.
Zlotowski Center of Neuroscience, Ben Gurion University, Beer Sheva, Israel.
Department of Neurology & Stroke, and Hertie-Institute for Clinical Brain Research, University of Tübingen, Germany.
Human Motor Control Section, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, MD, USA.

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.

中文翻译：

TMS 在健康受试者和患者群体中使用的安全性和建议，以及培训、伦理和监管问题的最新信息：专家指南

本文基于由国际临床神经生理学联合会 (IFCN) 推动和支持的共识会议，该会议于 2018 年 10 月在意大利锡耶纳举行。该会议旨在更新已有 10 年历史的安全指南经颅磁刺激 (TMS) 在研究和临床环境中的应用（Rossi 等，2009）。因此，仅详细讨论新出现的问题，而 2009 年关于常规或模式化 TMS 方案的描述、受试者/患者的筛选、新方案的神经生理学监测的需要、参考阈值的利用的建议仍然有效。刺激、癫痫发作的控制和一系列轻微副作用。截至2020年4月的会议详细讨论的新问题是最近开发的刺激装置和脉冲配置的安全问题；设备制造商的职责和责任；TMS 应用的新场景，例如神经影像背景或成像引导和机器人引导的 TMS；TMS 与经颅电刺激交替进行；配对联想刺激干预期间的安全性；以及使用 TMS 诱发治疗性癫痫发作（磁癫痫治疗）的风险。提供了可能诱发癫痫发作的最新信息，理论上这是 TMS 最严重的风险。很明显，即使对于服用作用于中枢神经系统的药物的患者，这种风险也很低，至少在使用传统刺激参数和可获得大量数据集的聚焦线圈的情况下是这样。最后，为基于传统和模式化 TMS 协议规划未来试验的安全性提供了新的操作指南，以及操作员最低培训要求的摘要以及关于神经增强伦理的说明。

更新日期：2021-01-01

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