Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines
Year: 2020
Type: article
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.
Source: Clinical Neurophysiology
Authors: 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
Institutions: University of Siena, Universitätsmedizin Göttingen, University of Göttingen, Otto-von-Guericke-Universität Magdeburg, Wellcome Centre for Human Neuroimaging, UCL Queen Square Institute of Neurology, University College London, City College of New York, National Institutes of Health, National Institute on Deafness and Other Communication Disorders, Brown University, Butler Hospital, University of Toronto, Krembil Research Institute, Centre for Addiction and Mental Health, Università Campus Bio-Medico, Beth Israel Deaconess Medical Center, Massachusetts General Hospital, Athinoula A. Martinos Center for Biomedical Imaging, Berenson Allen Center for Noninvasive Brain Stimulation, Medical University of South Carolina, Cincinnati Children's Hospital Medical Center, University of Cincinnati, Aristotle University of Thessaloniki, AHEPA University Hospital, Aalto University, Université Paris-Est Créteil, Centre Hospitalier Universitaire Henri-Mondor, Assistance Publique – Hôpitaux de Paris, Hôpitaux Universitaires Henri-Mondor, Excitabilité Nerveuse et Thérapeutique, Vita-Salute San Raffaele University, IRCCS Ospedale San Raffaele, Duke University, National Institute of Mental Health, Ben-Gurion University of the Negev, University of Trento, Universitat Autònoma de Barcelona, Institut Guttmann, Ludwig-Maximilians-Universität München, Fukushima Medical University, Harvard University, National Institute of Neurological Disorders and Stroke, Hebrew SeniorLife, University of Messina, Hertie Institute for Clinical Brain Research, University of Tübingen, IRCCS San Raffaele Roma, University of Copenhagen, Bispebjerg Hospital, Hvidovre Hospital, Copenhagen University Hospital
Language: English
Subfield: Neurology
Field: Neuroscience
Domain: Life Sciences
Open Access status: hybrid
Estimated APC paid: $2,500
Funders: Boston Scientific Corporation, Sage Therapeutics, BrainsWay, MagVenture, Lundbeckfonden, National Institutes of Health, Japan Society for the Promotion of Science, National Institute on Aging, National Institute of Mental Health, National Institute on Deafness and Other Communication Disorders, National Institute of Neurological Disorders and Stroke
Awards: Using fMRI-guided TMS to increase central executive function in older adults, Quiet TMS: A Low-Acoustic-Noise Transcranial Magnetic Stimulation System, Gamma Induction for Amyloid Clearance in Alzheimer's Disease, Transcranial magnetic stimulation with enhanced focality and depth (fdTMS), G2671819712, Impact of Timing, Targeting, and Brain State on rTMS of Human and Non-Human Primates, Neo-Rehabilitation and its Systems Neuroscience Explored by Novel Non-invasive Brain Stimulation, Clinical Analysis of Disorders of Hearing and Balance
OpenAlex ID: W3093743108