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

Simone Rossi, Andrea Antal, Sven Bestmann, Marom Bikson, Carmen Brewer, Jürgen Brockmöller, Linda L Carpenter, Massimo Cincotta, Robert Chen, Jeff D Daskalakis, Vincenzo Di Lazzaro, Michael D Fox, Mark S George, Donald Gilbert, Vasilios K Kimiskidis, Giacomo Koch, Risto J Ilmoniemi, Jean Pascal Lefaucheur, Letizia Leocani, Sarah H Lisanby, Carlo Miniussi, Frank Padberg, Alvaro Pascual-Leone, Walter Paulus, Angel V Peterchev, Angelo Quartarone, Alexander Rotenberg, John Rothwell, Paolo M Rossini, Emiliano Santarnecchi, Mouhsin M Shafi, Hartwig R Siebner, Yoshikatzu Ugawa, Eric M Wassermann, Abraham Zangen, Ulf Ziemann, Mark Hallett, basis of this article began with a Consensus Statement from the IFCN Workshop on "Present, Future of TMS: Safety, Ethical Guidelines", Siena, October 17-20, 2018, updating through April 2020, Simone Rossi, Andrea Antal, Sven Bestmann, Marom Bikson, Carmen Brewer, Jürgen Brockmöller, Linda L Carpenter, Massimo Cincotta, Robert Chen, Jeff D Daskalakis, Vincenzo Di Lazzaro, Michael D Fox, Mark S George, Donald Gilbert, Vasilios K Kimiskidis, Giacomo Koch, Risto J Ilmoniemi, Jean Pascal Lefaucheur, Letizia Leocani, Sarah H Lisanby, Carlo Miniussi, Frank Padberg, Alvaro Pascual-Leone, Walter Paulus, Angel V Peterchev, Angelo Quartarone, Alexander Rotenberg, John Rothwell, Paolo M Rossini, Emiliano Santarnecchi, Mouhsin M Shafi, Hartwig R Siebner, Yoshikatzu Ugawa, Eric M Wassermann, Abraham Zangen, Ulf Ziemann, Mark Hallett, basis of this article began with a Consensus Statement from the IFCN Workshop on "Present, Future of TMS: Safety, Ethical Guidelines", Siena, October 17-20, 2018, updating through April 2020

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.

Keywords: Neurology; Neuromodulation; Psychiatry; QPS; Safety; TBS; TMS; rTMS.

Conflict of interest statement

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Copyright © 2020 International Federation of Clinical Neurophysiology. Published by Elsevier B.V. All rights reserved.

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