A questionnaire to collect unintended effects of transcranial magnetic stimulation: A consensus based approach

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  • A. Giustiniani
  • A. Vallesi
  • M. Oliveri
  • V. Tarantino
  • E. Ambrosini
  • M. Bortoletto
  • F. Masina
  • P. Busan
  • L. Fadiga
  • G. Koch
  • L. Leocani
  • J. P. Lefaucheur
  • A. Rotenberg
  • A. Zangen
  • I. R. Violante
  • V. Moliadze
  • O. L. Gamboa
  • Y. Ugawa
  • A. Pascual-Leone
  • U. Ziemann
  • C. Miniussi
  • F. Burgio

Transcranial magnetic stimulation (TMS) has been widely used in both clinical and research practice. However, TMS might induce unintended sensations and undesired effects as well as serious adverse effects. To date, no shared forms are available to report such unintended effects. This study aimed at developing a questionnaire enabling reporting of TMS unintended effects. A Delphi procedure was applied which allowed consensus among TMS experts. A steering committee nominated a number of experts to be involved in the Delphi procedure. Three rounds were conducted before reaching a consensus. Afterwards, the questionnaire was publicized on the International Federation of Clinical Neurophysiology website to collect further suggestions by the wider scientific community. A last Delphi round was then conducted to obtain consensus on the suggestions collected during the publicization and integrate them in the questionnaire. The procedure resulted in a questionnaire, that is the TMSens_Q, applicable in clinical and research settings. Routine use of the structured TMS questionnaire and standard reporting of unintended TMS effects will help to monitor the safety of TMS, particularly when applying new protocols. It will also improve the quality of data collection as well as the interpretation of experimental findings.

OriginalsprogEngelsk
BogserieClinical Neurophysiology
Vol/bind141
Sider (fra-til)101-108
ISSN1388-2457
DOI
StatusUdgivet - 2022

Bibliografisk note

Funding Information:
Yoshikazu Ugawa received grants (KAKENHI grant numbers 19H01091 and 20K07866) from Japan Society for the Promotion of Science and grants from the Association of Radio Industries and Business and Tokyo Metropolitan Institute of Medical Science.

Funding Information:
We thank dr. Tendler Aron for reading the manuscript and providing his feedback. We are grateful to all panel members who participated in this Delphi consensus study: T.O. Bergmann, D. Blumberger, S. Borgomaneri, L. Boyd, N. Brihmat, A. Brunoni, G. Campana, L. Carpenter, L. Cattaneo, G. Cona, A. D'Ausilio, R. Dubbioso, M. Feurra, F. Fiori, P. Fitzgerald, A. Flöel, K. Hoy, Kallioniemi, C. Licht, L. Meteyard, T. Mitsuaki, M. Nitsche, G. Pellegrino, M.C. Pellicciari, I. Premoli, N. Rogasch, S. Rossi, M. Scheckelman, C.M. Stinear, A. Tomeh, P. Turriziani, C. Urgesi, A. Valero-Cabré, D. Veniero, X. Xue. Additionally, we thank all the authors that gave their contribution through the IFCN website: J.P. Appendino, M. Berg, N. Brihmat, A. Del Cerro León, C. Licht, M. Rogic, M. Scheckelman, C. Semenza, L. Seynaeve, M. Swash, A. Tomeh. Yoshikazu Ugawa received grants (KAKENHI grant numbers 19H01091 and 20K07866) from Japan Society for the Promotion of Science and grants from the Association of Radio Industries and Business and Tokyo Metropolitan Institute of Medical Science. Ulf Ziemann received grants from the German Ministry of Education and Research (BMBF), European Research Council (ERC), German Research Foundation (DFG), Janssen Pharmaceuticals NV and Takeda Pharmaceutical Company Ltd. and consulting fees from CorTec GmbH, all not related to this work. Hartwig R. Siebner has received honoraria as speaker from Sanofi Genzyme, Denmark and Novartis, Denmark, as consultant from Sanofi Genzyme, Denmark, Lophora, Denmark, and Lundbeck AS, Denmark, and as editor-in-chief (Neuroimage Clinical) and senior editor (NeuroImage) from Elsevier Publishers, Amsterdam, The Netherlands. He has received royalties as book editor from Springer Publishers, Stuttgart, Germany and from Gyldendal Publishers, Copenhagen, Denmark. Yoshikazu Ugawa has received honoraria from Takeda Pharmaceutical Company Limited, Eisai Co. Ltd. FP Pharmaceutical Corporation, Otsuka Pharmaceutical Co. Ltd. Elsevier Japan K. K. Kyowa Hakko Kirin Co. Ltd. Dainippon Sumitomo Pharma Co. Ltd. Mitsubishi Tanabe Pharma Corporation, NIHON PHARMACEUTICAL Co. Ltd. and Novartis Pharma K.K. He has received royalties as journal editor from CHUGAI-IGAKUSHA, Igaku-Shoin Ltd, Medical View Co. Ltd. and Blackwell Publishing K.K. This work was in part supported by “Progetto Giovani Ricercatori” from the Italian Ministry of Health (project code: GR-2018-12367927 – FINAGE, to F.B. and A.V.; project code: GR-2018-12366027, to P.B.), and by the “Department of Excellence 2018-2022” initiative of the Italian Ministry of University and Research (MIUR), awarded to the Department of Neuroscience – University of Padua. This work has been in part supported by a grant PRIN 2020 to L.F.

Funding Information:
Ulf Ziemann received grants from the German Ministry of Education and Research (BMBF), European Research Council (ERC), German Research Foundation (DFG), Janssen Pharmaceuticals NV and Takeda Pharmaceutical Company Ltd., and consulting fees from CorTec GmbH, all not related to this work.

Funding Information:
This work was in part supported by “Progetto Giovani Ricercatori” from the Italian Ministry of Health (project code: GR-2018-12367927 – FINAGE, to F.B. and A.V.; project code: GR-2018-12366027, to P.B.), and by the “Department of Excellence 2018-2022” initiative of the Italian Ministry of University and Research (MIUR), awarded to the Department of Neuroscience – University of Padua. This work has been in part supported by a grant PRIN 2020 to L.F.

Publisher Copyright:
© 2022 International Federation of Clinical Neurophysiology

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