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TMS_Safety,guidelines
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Guidelines Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research q Simone Rossi a,*, Mark Hallettb, Paolo M. Rossinic,d, Alvaro Pascual-Leonee and The Safety of TMS Consensus Group 1 aDipartimento di Neuroscienze, Sezione Neurologia, Università di Siena, Italy bHuman Motor Control Section, NINDS, NIH, Bethesda, USA cUniversità Campus Biomedico, Roma, Italy dCasa di Cura S. Raffaele, Cassino, Italy eBerenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, USA a r t i c l ei n f o Article history: Accepted 21 August 2009 Available online xxxx Keywords: Transcranial magnetic stimulation TMS rTMS Safety a b s t r a c t This article is based on a consensus conference, which took place in Certosa di Pontignano, Siena (Italy) on March 7–9, 2008, intended to update the previous safety guidelines for the application of transcranial magnetic stimulation (TMS) in research and clinical settings. Over the past decade the scientif i c and medical community has had the opportunity to evaluate the safety record of research studies and clinical applications of TMS and repetitive TMS (rTMS). In these years the number of applications of conventional TMS has grown impressively, new paradigms of stim- ulation have been developed (e.g., patterned repetitive TMS) and technical advances have led to new device designs and to the real-time integration of TMS with electroencephalography (EEG), positron emission tomography (PET) and functional magnetic resonance imaging (fMRI). Thousands of healthy subjects and patients with various neurological and psychiatric diseases have undergone TMS allowing a better assessment of relative risks. The occurrence of seizures (i.e., the most serious TMS-related acute adverse effect) has been extremely rare, with most of the few new cases receiving rTMS exceeding pre- vious guidelines, often in patients under treatment with drugs which potentially lower the seizure threshold. The present updated guidelines review issues of risk and safety of conventional TMS protocols, address the undesired effects and risks of emerging TMS interventions, the applications of TMS in patients with 1388-2457/$36.00 ? 2009 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved. doi:10.1016/j.clinph.2009.08.016 q A Consensus Statement from the International Workshop on ‘‘Present and Future of TMS: Safety and Ethical Guidelines”, Siena, March 7–9, 2008. * Corresponding author. Tel.: +39 0577 585401; fax: +39 0577 270260. E-mail address: rossisimo@unisi.it (S. Rossi). 1 Giuliano Avanzini, Neurocienze Cliniche, Istituto Nazionale Neurologico ‘‘C. Besta, Milano, Italy. Sven Bestmann, Sobell Department of Motor Neuroscience and Movement Disorders, UCL Institute of Neurology, London, UK. Alfredo Berardelli, Department of Neurological Sciences and Neuromed Institute, University of Rome ‘‘La Sapienza”, Roma, Italy. Carmen Brewer, National Institute on Deafness and other Communication Disorders, National Institutes of Health, Bethesda, MD, USA. Turhan Canli, Department of Psychology, Stony Brook University, New York, USA. Roberto Cantello, Dipartimento di Medicina Clinica e Sperimentale, Sezione Neurologia, Università del Piemonte Orientale ‘‘A. Avogadro”, Novara, Italy. Robert Chen, Toronto Western Research Institute and Division of Neurology, Department of Medicine, University of Toronto, Canada. Joseph Classen, Department of Neurology, University of Leipzig, Germany. Mark Demitrack, Neuronetics, Inc., Malvern, PA, USA. Vincenzo Di Lazzaro, Institute of Neurology, Univesità Cattolica, Roma, Italy. Charles M. Epstein, Department of Neurology, Emory University School of Medicine, Atlanta, USA. Mark S. George, Medical University of South Carolina, Charleston, SC, USA. Felipe Fregni, Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel. Deaconess Medical Center, Harvard Medical School, Boston, MA, USA. Risto Ilmoniemi, Department Biomed. Eng. and Computational Science (BECS), Helsinki, Finland. Reza Jalinous, Magstim Company, Boston, MA, USA. Barbara Karp, Combined NeuroScience IRB, National Institutes of Health, Bethesda, MD, USA. Jean-Pascal Lefaucheur, Service Physiologie, Explorations Fonctionnelles, Hpital Henri Mondor, Créteil, France. Sarah Lisanby, Division of Brain Stimulation & Therapeutic Modulation, Columbia University College of Physicians and Surgeons, New York State Psychiatric Institute, New York, NY, USA. Sabine Meunier, Service de Réadaptation Fonctionnelle, Hpital de la Salpêtrière, Paris, France. Carlo Miniussi, Cognitive Neuroscience Section, IRCCS San Giovanni di Dio Fatebenefratelli, Brescia, Italy. Pedro Miranda, Institute of Biophysics and Biomedical Engineering, Faculty of Science, University of Lisbon, Portugal. Frank Padberg, Klinik für Psychiatrie und Psychotherapie, Ludwig-Maximilians-Universitt München, Germany. Walter Paulus, Department of Clinical Neurophysiology, University of Goettingen, Germany. Angel Peterchev, Division of Brain Stimulation and Therapeutic Modulation, Department of Psychiatry and Department of Electrical Engineering, Columbia University, New York, NY, USA. Corinna Porteri, Bioethics Unit, IRCCS San Giovanni di Dio Fatebenefratelli, Brescia, Italy. Miriam Provost, Medical Devices Biologics Consulting Group, Inc., Athens, GA, USA. Angelo Quartarone, Dipartimento di Neuroscienze, Scienze Psichiatriche ed Anestesiologiche, Università di Messina, Italy. Alexander Rotenberg, Department of Neurology, Division of Epilepsy and Clinical Neurophysiology, Children’s Hospital, Harvard Medical School, Boston, MA, USA. John Rothwell, Sobell Department, Institute of Neurology, Queen Square, London, UK. Jarmo Ruohonen, Nexstim Ltd., Helsinki, Finland. Hartwig Siebner, Danish Research Centre for Magnetic Resonance, Copenhagen University Hospital Hvidovre, Denmark. Gregor Thut, Centre for Cognitive Neuroimaging, Department of Psychology, University of Glasgow, UK. Josep Valls-Solè, Neurology Department, Hospital Clínic, University of Barcelona, Spain Vincent Walsh, Institute of Cognitive Neuroscience and Department of Psychology University College London, London, UK. Yoshikatzu Ugawa, Department of Neurology, School of Medicine, Fukushima Medical University, Japan. Abraham Zangen, Department of Neurobiology, The Weizmann Institute of Science, Rehovot, Israel. Ulf Ziemann, Klinikum der Johann Wolfgang Goethe-Universitt Frankfurt am Main, Germany. Clinical Neurophysiology xxx (2009) xxx–xxx Contents lists available at ScienceDirect Clinical Neurophysiology journal homepage: www.elsevier.com/locate/clinph ARTICLE IN PRESS Please cite this article in press as: Rossi S et al. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol (2009), doi:10.1016/j.clinph.2009.08.016

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