Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research

Simone Rossi, Mark Hallett, Paolo M. Rossini, Alvaro Pascual-Leone, Giuliano Avanzini, Sven Bestmann, Alfredo Berardelli, Carmen Brewer, Turhan Canli, Roberto Cantello, Robert Chen, Joseph Classen, Mark Demitrack, Vincenzo Di Lazzaro, Charles M. Epstein, Mark S. George, Felipe Fregni, Risto Ilmoniemi, Reza Jalinous, Barbara KarpJean Pascal Lefaucheur, Sarah Lisanby, Sabine Meunier, Carlo Miniussi, Pedro Miranda, Frank Padberg, Walter Paulus, Angel Peterchev, Corinna Porteri, Miriam Provost, Angelo Quartarone, Alexander Rotenberg, John Rothwell, Jarmo Ruohonen, Hartwig Siebner, Gregor Thut, Josep Valls-Solè, Vincent Walsh, Yoshikatzu Ugawa, Abraham Zangen, Ulf Ziemann

Research output: Contribution to journalReview articlepeer-review

4062 Scopus citations

Abstract

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 scientific 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 stimulation 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 previous 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 implanted electrodes in the central nervous system, and safety aspects of TMS in neuroimaging environments. We cover recommended limits of stimulation parameters and other important precautions, monitoring of subjects, expertise of the rTMS team, and ethical issues. While all the recommendations here are expert based, they utilize published data to the extent possible.

Original languageEnglish
Pages (from-to)2008-2039
Number of pages32
JournalClinical Neurophysiology
Volume120
Issue number12
DOIs
StatePublished - 1 Dec 2009
Externally publishedYes

Keywords

  • Safety
  • TMS
  • Transcranial magnetic stimulation
  • rTMS

ASJC Scopus subject areas

  • Sensory Systems
  • Neurology
  • Clinical Neurology
  • Physiology (medical)

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