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Cited by 1,573Transcranial Magnetic Stimulation StudiesElectroconvulsive Therapy StudiesUltrasound and Hyperthermia Applications

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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Rossi, Simone, Antal, Andrea, Bestmann, Sven, Bikson, Marom, Brewer, Carmen, Brockmöller, Jürgen, Carpenter, Linda L., Cincotta, Massimo +29 more·2021·Clinical Neurophysiology
DOI 10.1016/j.clinph.2020.10.003PMC PMC9094636
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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.

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  • That no adverse events occurred is noteworthy because older adults have a higher likelihood of brain lesions, which may increase risk for TMS-related adverse events.

    “Older adults have a higher likelihood of having brain lesions [50] which may increase risk for TMS-related adverse events [51]; that no adverse events (e.g. seizures) occurred is therefore noteworthy.”

    From A phase I trial of accelerated intermittent theta burst rTMS for amnestic MCI (2024) · cites this paper as [51]

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Authors
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., Lefaucheur, J. P., Leocani, L., Lisanby, S. H., Miniussi, C., Padberg, F., Pascual-Leone, A., Paulus, W., Peterchev, A. V., Quartarone, A., Rotenberg, A., Rothwell, J., Rossini, P. M., Santarnecchi, E., Shafi, M. M., Siebner, H. R., Ugawa, Y., Wassermann, E. M., Zangen, A., Ziemann, U., & Hallett, M.
Affiliations
  • Universitätsmedizin Göttingen (DE)
  • Wellcome Centre for Human Neuroimaging (GB)
  • City College of New York (US)
  • National Institutes of Health (US)
  • Brown University (US)
  • University of Toronto (CA)
  • Beth Israel Deaconess Medical Center (US)
  • Medical University of South Carolina (US)
  • Cincinnati Children's Hospital Medical Center (US)
  • Aalto University (FI)
  • Université Paris-Est Créteil (FR)
  • Vita-Salute San Raffaele University (IT)
  • Ben-Gurion University of the Negev (IL)
  • Universitat Autònoma de Barcelona (ES)
  • Fukushima Medical University (JP)
  • Duke University (US)
  • University of Messina (IT)
  • Harvard University (US)
  • University of Copenhagen (DK)
ORCID
Venue
Clinical Neurophysiology
Publisher
Elsevier BV
Published
2021-01
Volume
132
Issue
1
Pages
269-306
ISSN
1388-2457 (ISSN-L)
DOI
10.1016/j.clinph.2020.10.003
PMC
PMC9094636
OpenAlex
W3093743108
Cited by
1,573
References
28
Citations by year
2026: 333 · 2025: 384 · 2024: 324 · 2023: 248 · 2022: 179 · 2021: 101 · 2020: 4
FWCI
51.50
Type
journal article
Language
en
Open access
Licence
Locations
  • Clinical Neurophysiology (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
  • Research at the University of Copenhagen (University of Copenhagen) (publishedVersion, cc-by-nc-nd)
  • PubMed Central (acceptedVersion, cc-by-nc-nd)
  • Aaltodoc (Aalto University) (submittedVersion, other-oa)
  • Dipòsit Digital de Documents de la UAB (Universitat Autònoma de Barcelona) (submittedVersion, cc-by-nc-nd)
  • UCL Discovery (University College London) (submittedVersion)
  • Institutional Research Information System University of Ferrara (University of Ferrara) (submittedVersion, other-oa)
  • Archivio Istituzionale della Ricerca - Università Vita-Salute San Raffaele (submittedVersion)
  • Institutional Research Information System (Università degli Studi di Trento) (submittedVersion, cc-by-nc-nd)
  • GoeScholar The Publication Server of the Georg-August-Universität Göttingen (Georg-August-Universität Göttingen) (submittedVersion, cc-by)
  • Use Siena air (University of Siena) (submittedVersion, cc-by-nc-nd)
Funders
  • Boston Scientific Corporation
  • Sage Therapeutics
  • BrainsWay
  • MagVenture
  • Lundbeckfonden (R186-2015-2138)
  • National Institutes of Health
  • Japan Society for the Promotion of Science (19H01091)
  • National Institute on Aging (U01AG050618, R01AG060981)
  • National Institute of Mental Health (R01MH111865, RF1MH114268, RF1MH114253)
  • National Institute on Deafness and Other Communication Disorders (ZIADC000064)
  • National Institute of Neurological Disorders and Stroke
Topics
  • Life Sciences › Neuroscience › Neurology › Transcranial Magnetic Stimulation Studies
  • Health Sciences › Medicine › Psychiatry and Mental health › Electroconvulsive Therapy Studies
  • Physical Sciences › Engineering › Biomedical Engineering › Ultrasound and Hyperthermia Applications
Keywords
transcranial magnetic stimulation, TMS safety, seizure induction, magnetic seizure therapy, paired associative stimulation, transcranial electrical stimulation, operator training, healthy volunteers, clinical trials
MeSH terms
Brain, Humans, Transcranial Magnetic Stimulation, Healthy Volunteers

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