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.

Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research / S., Rossi; M., Hallett; P. M., Rossini; A., Pascual Leone; G., Avanzini; S., Bestmann; A., Berardelli; C., Brewer; T., Canli; R., Cantello; R., Chen; J., Classen; M., Demitrack; V., Di Lazzaro; C. M., Epstein; M. S., George; F., Fregni; I., Risto; R., Jalinous; B., Karp; J. P., Lefaucheur; S., Lisanby; S., Meunier; Miniussi, Carlo; P., Miranda; F., Padberg; W., Paulus; A., Peterchev; C., Porteri; M., Provost; A., Quartarone; A., Rotenberg; J., Rothwell; J., Ruohonen; H., Siebner; G., Thut; J., Valls Solè; Y., Ugaw; A., Zangen; U., Ziemann. - In: CLINICAL NEUROPHYSIOLOGY. - ISSN 1388-2457. - 2009, 120:(2009), pp. 2008-2039. [10.1016/j.clinph.2009.08.016]

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

Miniussi, Carlo;
2009-01-01

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.
2009
S., Rossi; M., Hallett; P. M., Rossini; A., Pascual Leone; G., Avanzini; S., Bestmann; A., Berardelli; C., Brewer; T., Canli; R., Cantello; R., Chen; J., Classen; M., Demitrack; V., Di Lazzaro; C. M., Epstein; M. S., George; F., Fregni; I., Risto; R., Jalinous; B., Karp; J. P., Lefaucheur; S., Lisanby; S., Meunier; Miniussi, Carlo; P., Miranda; F., Padberg; W., Paulus; A., Peterchev; C., Porteri; M., Provost; A., Quartarone; A., Rotenberg; J., Rothwell; J., Ruohonen; H., Siebner; G., Thut; J., Valls Solè; Y., Ugaw; A., Zangen; U., Ziemann
Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research / S., Rossi; M., Hallett; P. M., Rossini; A., Pascual Leone; G., Avanzini; S., Bestmann; A., Berardelli; C., Brewer; T., Canli; R., Cantello; R., Chen; J., Classen; M., Demitrack; V., Di Lazzaro; C. M., Epstein; M. S., George; F., Fregni; I., Risto; R., Jalinous; B., Karp; J. P., Lefaucheur; S., Lisanby; S., Meunier; Miniussi, Carlo; P., Miranda; F., Padberg; W., Paulus; A., Peterchev; C., Porteri; M., Provost; A., Quartarone; A., Rotenberg; J., Rothwell; J., Ruohonen; H., Siebner; G., Thut; J., Valls Solè; Y., Ugaw; A., Zangen; U., Ziemann. - In: CLINICAL NEUROPHYSIOLOGY. - ISSN 1388-2457. - 2009, 120:(2009), pp. 2008-2039. [10.1016/j.clinph.2009.08.016]
File in questo prodotto:
File Dimensione Formato  
Clin-N_Rossi_09.pdf

accesso aperto

Tipologia: Post-print referato (Refereed author’s manuscript)
Licenza: Tutti i diritti riservati (All rights reserved)
Dimensione 688.38 kB
Formato Adobe PDF
688.38 kB Adobe PDF Visualizza/Apri

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11572/145680
Citazioni
  • ???jsp.display-item.citation.pmc??? ND
  • Scopus 3940
  • ???jsp.display-item.citation.isi??? 3672
social impact