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Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines
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 magneti...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9094636/ https://www.ncbi.nlm.nih.gov/pubmed/33243615 http://dx.doi.org/10.1016/j.clinph.2020.10.003 |
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author | Rossi, Simone Antal, Andrea Bestmann, Sven Bikson, Marom Brewer, Carmen Brockmöller, Jürgen Carpenter, Linda L. Cincotta, Massimo Chen, Robert Daskalakis, Jeff D. Di Lazzaro, Vincenzo Fox, Michael D. George, Mark S. Gilbert, Donald Kimiskidis, Vasilios K. Koch, Giacomo Ilmoniemi, Risto J. Lefaucheur, Jean Pascal Leocani, Letizia Lisanby, Sarah H. Miniussi, Carlo Padberg, Frank Pascual-Leone, Alvaro Paulus, Walter Peterchev, Angel V. Quartarone, Angelo Rotenberg, Alexander Rothwell, John Rossini, Paolo M. Santarnecchi, Emiliano Shafi, Mouhsin M. Siebner, Hartwig R. Ugawa, Yoshikatzu Wassermann, Eric M. Zangen, Abraham Ziemann, Ulf Hallett, Mark |
author_facet | Rossi, Simone Antal, Andrea Bestmann, Sven Bikson, Marom Brewer, Carmen Brockmöller, Jürgen Carpenter, Linda L. Cincotta, Massimo Chen, Robert Daskalakis, Jeff D. Di Lazzaro, Vincenzo Fox, Michael D. George, Mark S. Gilbert, Donald Kimiskidis, Vasilios K. Koch, Giacomo Ilmoniemi, Risto J. Lefaucheur, Jean Pascal Leocani, Letizia Lisanby, Sarah H. Miniussi, Carlo Padberg, Frank Pascual-Leone, Alvaro Paulus, Walter Peterchev, Angel V. Quartarone, Angelo Rotenberg, Alexander Rothwell, John Rossini, Paolo M. Santarnecchi, Emiliano Shafi, Mouhsin M. Siebner, Hartwig R. Ugawa, Yoshikatzu Wassermann, Eric M. Zangen, Abraham Ziemann, Ulf Hallett, Mark |
author_sort | Rossi, Simone |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-9094636 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
record_format | MEDLINE/PubMed |
spelling | pubmed-90946362022-05-11 Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines Rossi, Simone Antal, Andrea Bestmann, Sven Bikson, Marom Brewer, Carmen Brockmöller, Jürgen Carpenter, Linda L. Cincotta, Massimo Chen, Robert Daskalakis, Jeff D. Di Lazzaro, Vincenzo Fox, Michael D. George, Mark S. Gilbert, Donald Kimiskidis, Vasilios K. Koch, Giacomo Ilmoniemi, Risto J. Lefaucheur, Jean Pascal Leocani, Letizia Lisanby, Sarah H. Miniussi, Carlo Padberg, Frank Pascual-Leone, Alvaro Paulus, Walter Peterchev, Angel V. Quartarone, Angelo Rotenberg, Alexander Rothwell, John Rossini, Paolo M. Santarnecchi, Emiliano Shafi, Mouhsin M. Siebner, Hartwig R. Ugawa, Yoshikatzu Wassermann, Eric M. Zangen, Abraham Ziemann, Ulf Hallett, Mark Clin Neurophysiol Article 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. 2021-01 2020-10-24 /pmc/articles/PMC9094636/ /pubmed/33243615 http://dx.doi.org/10.1016/j.clinph.2020.10.003 Text en https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) ). |
spellingShingle | Article Rossi, Simone Antal, Andrea Bestmann, Sven Bikson, Marom Brewer, Carmen Brockmöller, Jürgen Carpenter, Linda L. Cincotta, Massimo Chen, Robert Daskalakis, Jeff D. Di Lazzaro, Vincenzo Fox, Michael D. George, Mark S. Gilbert, Donald Kimiskidis, Vasilios K. Koch, Giacomo Ilmoniemi, Risto J. Lefaucheur, Jean Pascal Leocani, Letizia Lisanby, Sarah H. Miniussi, Carlo Padberg, Frank Pascual-Leone, Alvaro Paulus, Walter Peterchev, Angel V. Quartarone, Angelo Rotenberg, Alexander Rothwell, John Rossini, Paolo M. Santarnecchi, Emiliano Shafi, Mouhsin M. Siebner, Hartwig R. Ugawa, Yoshikatzu Wassermann, Eric M. Zangen, Abraham Ziemann, Ulf Hallett, Mark Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines |
title | Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines |
title_full | Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines |
title_fullStr | Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines |
title_full_unstemmed | Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines |
title_short | Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines |
title_sort | safety and recommendations for tms use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: expert guidelines |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9094636/ https://www.ncbi.nlm.nih.gov/pubmed/33243615 http://dx.doi.org/10.1016/j.clinph.2020.10.003 |
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