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

Publikation: Bidrag til tidsskrift › Review › Forskning › fagfællebedømt

Standard

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.; Pascal Lefaucheur, Jean; 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.

I: Clinical Neurophysiology, Bind 132, Nr. 1, 2021, s. 269-306.

Publikation: Bidrag til tidsskrift › Review › Forskning › fagfællebedømt

Harvard

Rossi, S, Antal, A, Bestmann, S, Bikson, M, Brewer, C, Brockmöller, J, Carpenter, LL, Cincotta, M, Chen, R, Daskalakis, JD, Di Lazzaro, V, Fox, MD, George, MS, Gilbert, D, Kimiskidis, VK, Koch, G, Ilmoniemi, RJ, Pascal Lefaucheur, J, Leocani, L, Lisanby, SH, Miniussi, C, Padberg, F, Pascual-Leone, A, Paulus, W, Peterchev, AV, Quartarone, A, Rotenberg, A, Rothwell, J, Rossini, PM, Santarnecchi, E, Shafi, MM, Siebner, HR, Ugawa, Y, Wassermann, EM, Zangen, A, Ziemann, U & Hallett, M 2021, 'Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines', Clinical Neurophysiology, bind 132, nr. 1, s. 269-306. https://doi.org/10.1016/j.clinph.2020.10.003

APA

Rossi, S., Antal, A., Bestmann, S., Bikson, M., Brewer, C., Brockmöller, J., Carpenter, L. L., Cincotta, M., Chen, R., Daskalakis, J. D., Di Lazzaro, V., Fox, M. D., George, M. S., Gilbert, D., Kimiskidis, V. K., Koch, G., Ilmoniemi, R. J., Pascal Lefaucheur, J., Leocani, L., ... Hallett, M. (2021). Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines. Clinical Neurophysiology, 132(1), 269-306. https://doi.org/10.1016/j.clinph.2020.10.003

Vancouver

Rossi S, Antal A, Bestmann S, Bikson M, Brewer C, Brockmöller J o.a. Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines. Clinical Neurophysiology. 2021;132(1):269-306. https://doi.org/10.1016/j.clinph.2020.10.003

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. ; Pascal Lefaucheur, Jean ; 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. I: Clinical Neurophysiology. 2021 ; Bind 132, Nr. 1. s. 269-306.

Bibtex

@article{0bb7587dac4b4d41a4f312a2d32e4710,
title = "Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines",
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, rTMS, Safety, TBS, TMS",
author = "Simone Rossi and Andrea Antal and Sven Bestmann and Marom Bikson and Carmen Brewer and J{\"u}rgen Brockm{\"o}ller and Carpenter, {Linda L.} and Massimo Cincotta and Robert Chen and Daskalakis, {Jeff D.} and {Di Lazzaro}, Vincenzo and Fox, {Michael D.} and George, {Mark S.} and Donald Gilbert and Kimiskidis, {Vasilios K.} and Giacomo Koch and Ilmoniemi, {Risto J.} and {Pascal Lefaucheur}, Jean and Letizia Leocani and Lisanby, {Sarah H.} and Carlo Miniussi and Frank Padberg and Alvaro Pascual-Leone and Walter Paulus and Peterchev, {Angel V.} and Angelo Quartarone and Alexander Rotenberg and John Rothwell and Rossini, {Paolo M.} and Emiliano Santarnecchi and Shafi, {Mouhsin M.} and Siebner, {Hartwig R.} and Yoshikatzu Ugawa and Wassermann, {Eric M.} and Abraham Zangen and Ulf Ziemann and Mark Hallett",
year = "2021",
doi = "10.1016/j.clinph.2020.10.003",
language = "English",
volume = "132",
pages = "269--306",
journal = "Clinical Neurophysiology",
issn = "1388-2457",
publisher = "Elsevier Ireland Ltd",
number = "1",

}

RIS

TY - JOUR

T1 - Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues

T2 - Expert Guidelines

AU - Rossi, Simone

AU - Antal, Andrea

AU - Bestmann, Sven

AU - Bikson, Marom

AU - Brewer, Carmen

AU - Brockmöller, Jürgen

AU - Carpenter, Linda L.

AU - Cincotta, Massimo

AU - Chen, Robert

AU - Daskalakis, Jeff D.

AU - Di Lazzaro, Vincenzo

AU - Fox, Michael D.

AU - George, Mark S.

AU - Gilbert, Donald

AU - Kimiskidis, Vasilios K.

AU - Koch, Giacomo

AU - Ilmoniemi, Risto J.

AU - Pascal Lefaucheur, Jean

AU - Leocani, Letizia

AU - Lisanby, Sarah H.

AU - Miniussi, Carlo

AU - Padberg, Frank

AU - Pascual-Leone, Alvaro

AU - Paulus, Walter

AU - Peterchev, Angel V.

AU - Quartarone, Angelo

AU - Rotenberg, Alexander

AU - Rothwell, John

AU - Rossini, Paolo M.

AU - Santarnecchi, Emiliano

AU - Shafi, Mouhsin M.

AU - Siebner, Hartwig R.

AU - Ugawa, Yoshikatzu

AU - Wassermann, Eric M.

AU - Zangen, Abraham

AU - Ziemann, Ulf

AU - Hallett, Mark

PY - 2021

Y1 - 2021

N2 - 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.

AB - 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.

KW - Neurology

KW - Neuromodulation

KW - Psychiatry

KW - QPS

KW - rTMS

KW - Safety

KW - TBS

KW - TMS

U2 - 10.1016/j.clinph.2020.10.003

DO - 10.1016/j.clinph.2020.10.003

M3 - Review

C2 - 33243615

AN - SCOPUS:85096381932

VL - 132

SP - 269

EP - 306

JO - Clinical Neurophysiology

JF - Clinical Neurophysiology

SN - 1388-2457

IS - 1

ER -

ID: 253146531