Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines
•This article updates the previous safety guidelines from 2009.•Safety of new devices and techniques is considered.•Operational guidelines for future protocols using TMS are provided. This article is based on a consensus conference, promoted and supported by the International Federation of Clinical...
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Published in | Clinical neurophysiology Vol. 132; no. 1; pp. 269 - 306 |
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Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
Format | Journal Article |
Language | English |
Published |
Netherlands
Elsevier B.V
01.01.2021
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Subjects | |
Online Access | Get full text |
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Abstract | •This article updates the previous safety guidelines from 2009.•Safety of new devices and techniques is considered.•Operational guidelines for future protocols using TMS are provided.
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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AbstractList | 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. Highlights•This article updates the previous safety guidelines from 2009. •Safety of new devices and techniques is considered. •Operational guidelines for future protocols using TMS are provided. •This article updates the previous safety guidelines from 2009.•Safety of new devices and techniques is considered.•Operational guidelines for future protocols using TMS are provided. 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. 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. 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.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. |
Author | Wassermann, Eric M. Bikson, Marom Cincotta, Massimo Antal, Andrea Lefaucheur, Jean Pascal Kimiskidis, Vasilios K. George, Mark S. Lisanby, Sarah H. Koch, Giacomo Bestmann, Sven Quartarone, Angelo Siebner, Hartwig R. Di Lazzaro, Vincenzo Padberg, Frank Brewer, Carmen Ziemann, Ulf Santarnecchi, Emiliano Gilbert, Donald Ilmoniemi, Risto J. Daskalakis, Jeff D. Rossini, Paolo M. Rotenberg, Alexander Rossi, Simone Pascual-Leone, Alvaro Zangen, Abraham Miniussi, Carlo Paulus, Walter Ugawa, Yoshikatzu Carpenter, Linda L. Hallett, Mark Brockmöller, Jürgen Fox, Michael D. Leocani, Letizia Rothwell, John Shafi, Mouhsin M. Chen, Robert Peterchev, Angel V. |
AuthorAffiliation | j Krembil Research Institute and Division of Neurology, Department of Medicine, University of Toronto, Canada c Institue of Medical Psychology, Otto-Guericke University Magdeburg, Germany ap Human Motor Control Section, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, MD, USA ai Danish Research Centre for Magnetic Resonance, Copenhagen University Hospital Hvidovre, Copenhagen, Denmark e Department of Biomedical Engineering, The City College of New York, New York, NY, USA ae Departments of Psychiatry & Behavioral Sciences, Biomedical Engineering, Electrical & Computer Engineering, and Neurosurgery, Duke University, Durham, NC, USA z Center for Mind/Brain Sciences – CIMeC, University of Trento, Rovereto, Italy ag Department of Neurology, Division of Epilepsy and Clinical Neurophysiology, Children’s Hospital, Harvard Medical School, Boston, MA, USA o Athinoula A. Martinos Center for Biomedical Imaging, Massachusetts General Hospital, |
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Author_xml | – sequence: 1 givenname: Simone surname: Rossi fullname: Rossi, Simone email: Simone.rossi@unisi.it organization: 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 – sequence: 2 givenname: Andrea surname: Antal fullname: Antal, Andrea organization: Department of Clinical Neurophysiology, University Medical Center, Georg-August University of Goettingen, Germany – sequence: 3 givenname: Sven surname: Bestmann fullname: Bestmann, Sven organization: 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 – sequence: 4 givenname: Marom surname: Bikson fullname: Bikson, Marom organization: Department of Biomedical Engineering, The City College of New York, New York, NY, USA – sequence: 5 givenname: Carmen surname: Brewer fullname: Brewer, Carmen organization: National Institute on Deafness and Other Communication Disorders, National Institutes of Health (NIH), Bethesda, MD, USA – sequence: 6 givenname: Jürgen surname: Brockmöller fullname: Brockmöller, Jürgen organization: Department of Clinical Pharmacology, University Medical Center, Georg-August University of Goettingen, Germany – sequence: 7 givenname: Linda L. surname: Carpenter fullname: Carpenter, Linda L. organization: Butler Hospital, Brown University Department of Psychiatry and Human Behavior, Providence, RI, USA – sequence: 8 givenname: Massimo surname: Cincotta fullname: Cincotta, Massimo organization: Unit of Neurology of Florence - Central Tuscany Local Health Authority, Florence, Italy – sequence: 9 givenname: Robert surname: Chen fullname: Chen, Robert organization: Krembil Research Institute and Division of Neurology, Department of Medicine, University of Toronto, Canada – sequence: 10 givenname: Jeff D. surname: Daskalakis fullname: Daskalakis, Jeff D. organization: Center for Addiction and Mental Health (CAMH), University of Toronto, Canada – sequence: 11 givenname: Vincenzo surname: Di Lazzaro fullname: Di Lazzaro, Vincenzo organization: Unit of Neurology, Neurophysiology, Neurobiology, Department of Medicine, Università Campus Bio-Medico, Roma, Italy – sequence: 12 givenname: Michael D. surname: Fox fullname: Fox, Michael D. organization: Berenson-Allen Center for Noninvasive Brain Stimulation, Department of Neurology, Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, MA, USA – sequence: 13 givenname: Mark S. surname: George fullname: George, Mark S. organization: Medical University of South Carolina, Charleston, SC, USA – sequence: 14 givenname: Donald orcidid: 0000-0002-9245-6878 surname: Gilbert fullname: Gilbert, Donald organization: Division of Neurology, Department of Pediatrics, Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, OH, USA – sequence: 15 givenname: Vasilios K. surname: Kimiskidis fullname: Kimiskidis, Vasilios K. organization: Laboratory of Clinical Neurophysiology, Aristotle University of Thessaloniki, AHEPA University Hospital, Greece – sequence: 16 givenname: Giacomo surname: Koch fullname: Koch, Giacomo organization: IRCCS Santa Lucia, Roma, Italy – sequence: 17 givenname: Risto J. surname: Ilmoniemi fullname: Ilmoniemi, Risto J. organization: Department of Neuroscience and Biomedical Engineering (NBE), Aalto University School of Science, Aalto, Finland – sequence: 18 givenname: Jean Pascal surname: Lefaucheur fullname: Lefaucheur, Jean Pascal organization: EA 4391, ENT Team, Faculty of Medicine, Paris Est Creteil University (UPEC), Créteil, France – sequence: 19 givenname: Letizia surname: Leocani fullname: Leocani, Letizia organization: Department of Neurology, Institute of Experimental Neurology (INSPE), IRCCS-San Raffaele Hospital, Vita-Salute San Raffaele University, Milano, Italy – sequence: 20 givenname: Sarah H. surname: Lisanby fullname: Lisanby, Sarah H. organization: National Institute of Mental Health (NIMH), National Institutes of Health (NIH), Bethesda, MD, USA – sequence: 21 givenname: Carlo surname: Miniussi fullname: Miniussi, Carlo organization: Center for Mind/Brain Sciences – CIMeC, University of Trento, Rovereto, Italy – sequence: 22 givenname: Frank surname: Padberg fullname: Padberg, Frank organization: Department of Psychiatry and Psychotherapy, University Hospital, LMU Munich, Munich, Germany – sequence: 23 givenname: Alvaro surname: Pascual-Leone fullname: Pascual-Leone, Alvaro organization: Hinda and Arthur Marcus Institute for Aging Research and Center for Memory Health, Hebrew SeniorLife, USA – sequence: 24 givenname: Walter surname: Paulus fullname: Paulus, Walter organization: Department of Clinical Neurophysiology, University Medical Center, Georg-August University of Goettingen, Germany – sequence: 25 givenname: Angel V. surname: Peterchev fullname: Peterchev, Angel V. organization: Departments of Psychiatry & Behavioral Sciences, Biomedical Engineering, Electrical & Computer Engineering, and Neurosurgery, Duke University, Durham, NC, USA – sequence: 26 givenname: Angelo surname: Quartarone fullname: Quartarone, Angelo organization: Department of Biomedical, Dental Sciences and Morphological and Functional Images, University of Messina, Messina, Italy – sequence: 27 givenname: Alexander surname: Rotenberg fullname: Rotenberg, Alexander organization: Department of Neurology, Division of Epilepsy and Clinical Neurophysiology, Children's Hospital, Harvard Medical School, Boston, MA, USA – sequence: 28 givenname: John surname: Rothwell fullname: Rothwell, John organization: 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 – sequence: 29 givenname: Paolo M. surname: Rossini fullname: Rossini, Paolo M. organization: Department of Neuroscience and Rehabilitation, IRCCS San Raffaele-Pisana, Roma, Italy – sequence: 30 givenname: Emiliano surname: Santarnecchi fullname: Santarnecchi, Emiliano organization: Berenson-Allen Center for Noninvasive Brain Stimulation, Department of Neurology, Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, MA, USA – sequence: 31 givenname: Mouhsin M. surname: Shafi fullname: Shafi, Mouhsin M. organization: Berenson-Allen Center for Noninvasive Brain Stimulation, Department of Neurology, Harvard Medical School and Beth Israel Deaconess Medical Center, Boston, MA, USA – sequence: 32 givenname: Hartwig R. surname: Siebner fullname: Siebner, Hartwig R. organization: Danish Research Centre for Magnetic Resonance, Copenhagen University Hospital Hvidovre, Copenhagen, Denmark – sequence: 33 givenname: Yoshikatzu surname: Ugawa fullname: Ugawa, Yoshikatzu organization: Department of Human Neurophysiology, School of Medicine, Fukushima Medical University, Fukushima, Japan – sequence: 34 givenname: Eric M. surname: Wassermann fullname: Wassermann, Eric M. organization: National Institute of Neurological Disorders and Stroke, Bethesda, MD, USA – sequence: 35 givenname: Abraham surname: Zangen fullname: Zangen, Abraham organization: Zlotowski Center of Neuroscience, Ben Gurion University, Beer Sheva, Israel – sequence: 36 givenname: Ulf orcidid: 0000-0001-8372-3615 surname: Ziemann fullname: Ziemann, Ulf organization: Department of Neurology & Stroke, and Hertie-Institute for Clinical Brain Research, University of Tübingen, Germany – sequence: 37 givenname: Mark surname: Hallett fullname: Hallett, Mark email: hallettm@ninds.nih.gov organization: Human Motor Control Section, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, MD, USA |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/33243615$$D View this record in MEDLINE/PubMed |
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Snippet | •This article updates the previous safety guidelines from 2009.•Safety of new devices and techniques is considered.•Operational guidelines for future protocols... Highlights•This article updates the previous safety guidelines from 2009. •Safety of new devices and techniques is considered. •Operational guidelines for... This article is based on a consensus conference, promoted and supported by the International Federation of Clinical Neurophysiology (IFCN), which took place in... |
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SubjectTerms | Brain - physiology Healthy Volunteers Humans Neurology Neuromodulation Psychiatry QPS rTMS Safety TBS TMS Transcranial Magnetic Stimulation - adverse effects |
Title | Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines |
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