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

Abstract

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.

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Affiliated Institutions

• City College of New York US
• Harvard University US
• Athinoula A. Martinos Center for Biomedical Imaging US
• Assistance Publique – Hôpitaux de Paris FR
• Copenhagen University Hospital DK
• Institut Guttmann ES
• Krembil Research Institute
• University of Göttingen DE
• University College London GB
• Krembil Foundation CA
• University of Messina IT
• National Institute on Deafness and Other Communication Disorders US
• University of Toronto CA
• Otto-von-Guericke University Magdeburg DE
• Istituti di Ricovero e Cura a Carattere Scientifico IT
• National Institute of Mental Health US
• Hertie Institute for Clinical Brain Research DE
• Duke University US
• Centre for Addiction and Mental Health CA
• University of Copenhagen DK
• Ludwig-Maximilians-Universität München DE
• Aristotle University of Thessaloniki GR
• Massachusetts General Hospital US
• IRCCS Ospedale San Raffaele IT
• AHEPA University Hospital GR
• Università Campus Bio-Medico IT
• Wellcome Centre for Human Neuroimaging GB
• Cincinnati Children's Hospital Medical Center US
• Bispebjerg Hospital DK
• Providence College US
• Fondazione Santa Lucia IT
• Medical University of South Carolina US
• Hebrew SeniorLife US
• LMU Klinikum DE
• University of Tübingen DE
• Boston Children's Hospital US
• Aalto University FI
• Brown University US
• National Institute of Neurological Disorders and Stroke US
• Agenzia Regionale di Sanità della Toscana IT
• National Institutes of Health US
• Hôpitaux Universitaires Henri-Mondor FR
• University of Siena IT
• University of Trento IT
• University of Cincinnati US
• National Hospital for Neurology and Neurosurgery GB
• Vita-Salute San Raffaele University IT
• Berenson Allen Center for Noninvasive Brain Stimulation US
• Beth Israel Deaconess Medical Center US
• Université Paris-Est Créteil FR
• Butler Hospital US
• Fukushima Medical University JP
• Ben-Gurion University of the Negev IL

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