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The consequences of the new European reclassification of non-invasive brain stimulation devices and the medical device regulations pose an existential threat to research and treatment: An invited opinion paper.

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Title: The consequences of the new European reclassification of non-invasive brain stimulation devices and the medical device regulations pose an existential threat to research and treatment: An invited opinion paper.
Authors: Antal A; Department of Neurology, University Medical Center Göttingen, Göttingen. Germany. Electronic address: aantal@gwdg.de., Ganho-Ávila A; Center for Research in Neuropsychology and Cognitive Behavioral Intervention, Faculty of Psychology and Educational Sciences, University of Coimbra, Coimbra, Portugal., Assecondi S; Centre for Mind/Brain Sciences - CIMeC, University of Trento, Rovereto (TN), Italy., Barbour T; Massachusetts General Hospital, Department of Psychiatry, Harvard Medical School, Boston, MA, USA., Bjekić J; University of Belgrade, Institute for Medical Research, Human Neuroscience Group and Centre for Neuroscience and Neuromodulation Belgrade, Serbia., Blumberger DM; Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health and Department of Psychiatry, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada., Bolognini N; Department of Psychology, University of Milano Bicocca, and Laboratory of Neuropsychology, IRCCS Istituto Auxologico Italiano, Milano, Italy., Brunelin J; CH Le Vinatier, Université Claude Bernard Lyon 1, CNRS, INSERM, Centre de Recherche en Neurosciences de Lyon CRNL, Bron, France., Chanes L; Department of Clinical and Health Psychology-Institute of Neurosciences, Universitat Autònoma de Barcelona, Barcelone, Spain., Dale M; Magstim, Spring Gardens, Whitland, Carmarthenshire, SA34 0HR, UK., Dubbioso R; Neurophysiology Unit, Department of Neurosciences, Reproductive Sciences and Odontostomatology, University of Naples, Naples, Italy., D'Urso G; Department of Neurosciences, Reproductive and Odontostomatological Sciences, University of Naples 'Federico II', Naples, Italy., Filipcic I; Psychiatric Clinic 'Sveti Ivan', Zagreb, Croatia., Filipović SR; University of Belgrade, Institute for Medical Research, Human Neuroscience Group and Centre for Neuroscience and Neuromodulation, Belgrade, Serbia., Hirnstein M; Department of Biological and Medical Psychology, University of Bergen, Bergen, Norway., Konings F; Independent expert by experience contributor, Amsterdam, the Netherlands., Langguth B; Chair of the German Society for Brain Stimulation in Psychiatry, Department of Psychiatry and Psychotherapy, Bezirksklinikum, University of Regensburg, Germany., Leocani L; Experimental Neurophysiology Unit, Institute of Experimental Neurology-INSPE, San Raffaele Scientific Institute, Milan, Italy; Faculty of Medicine, Vita-Salute San Raffaele University, Milan, Italy., Sorkhabi MM; Magstim, Spring Gardens, Whitland, Carmarthenshire SA34 0HR, UK., Mulder M; Independent expert by experience contributor, The Hague, the Netherlands., Nikander M; Sooma Oy, Helsinki, Finland., Nowak R; Neuroelectrics, Barcelona, Catalonia, Spain., Oliviero A; FENNSI Group, Hospital Nacional de PArapléjicos, SESCAM, Toledo, Spain; Center for Clinical Neuroscience - Hospital 'Los Madroños', Brunete (Madrid), Spain., Onarheim B; School of Psychology and Humanities, University of Central Lancashire, U.K., O'Shea J; Department of Psychiatry, University of Oxford, U.K., Pallanti S; Istituto di Neuroscienze (Italy) and Albert Einstein College of Medicine (NY. USA) Chair of ECNP Network on Neuromodulation., Rachid F; Private Practice, 7, place de la Fusterie, 1204, Geneva, Switzerland., Rajão-Saraiva J; Independent expert by experience contributor, Coimbra, Portugal., Rossi S; Siena Brain Investigation and Neuromodulation Lab (SiBIN Lab), Department of Medicine, Surgery and Neuroscience, University of Siena, Italy., Sack AT; Section Brain Stimulation and Cognition, Department of Cognitive Neuroscience, Faculty of Psychology and Neuroscience, Maastricht University (UM); Department of Psychiatry and Neuropsychology, School for Mental Health and Neuroscience (MHeNs), Brain+Nerve Centre, Maastricht University Medical Center (MUMC+), Center for Integrative Neuroscience (CIN), the Netherlands., Sauvaget A; Department of Psychiatry, University Hospital of Nantes, France., van der Scheer R; Independent Patient Representative Advisor in Adult, Child & Adolescent Psychiatry, Venlo, the Netherlands., Schellhorn K; neuroConn GmbH, Ilmenau, Germany., Soria-Frisch A; Neuroscience BU, Starlab Barcelona, Spain., Szekely D; Deputy Head of Neuromodulation Unit of Princess Grace Hospital Centre, Monaco., Tankisi H; Head of the Europa, Middle East, Africa Chapter of the International Federation of Clinical Neurophysiology, Department of Clinical Neurophysiology, Aarhus University Hospital and Department of Clinical Institute, Aarhus University, Aarhus, Denmark., Cj Taylor P; Department of Psychology, LMU Munich, Munich, Germany., Tendolkar I; Donders Institute for Brain, Cognition and Behavior, Department of Psychiatry, Radboud University Nijmegen, Netherlands., Uusitalo S; Philosophy (ethics), University of Oulu, Finland., Baeken C; Department of Head and Skin - Psychiatry and Medical Psychology, Ghent Experimental Psychiatry (GHEP) Lab, Ghent University, Ghent, Belgium; Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Department of Psychiatry, Brussels, Belgium; Department of Electrical Engineering, Eindhoven University of Technology, Eindhoven, the Netherlands.
Source: Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology [Clin Neurophysiol] 2024 Jul; Vol. 163, pp. 280-291. Date of Electronic Publication: 2024 Apr 10.
Publication Type: Journal Article
Journal Info: Publisher: Elsevier Country of Publication: Netherlands NLM ID: 100883319 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1872-8952 (Electronic) Linking ISSN: 13882457 NLM ISO Abbreviation: Clin Neurophysiol Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: The consequences of the new European reclassification of non-invasive brain stimulation devices and the medical device regulations pose an existential threat to research and treatment: An invited opinion paper.
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  Data: <searchLink fieldCode="AU" term="%22Antal+A%22">Antal A</searchLink>; Department of Neurology, University Medical Center Göttingen, Göttingen. Germany. Electronic address: aantal@gwdg.de.<br /><searchLink fieldCode="AU" term="%22Ganho-Ávila+A%22">Ganho-Ávila A</searchLink>; Center for Research in Neuropsychology and Cognitive Behavioral Intervention, Faculty of Psychology and Educational Sciences, University of Coimbra, Coimbra, Portugal.<br /><searchLink fieldCode="AU" term="%22Assecondi+S%22">Assecondi S</searchLink>; Centre for Mind/Brain Sciences - CIMeC, University of Trento, Rovereto (TN), Italy.<br /><searchLink fieldCode="AU" term="%22Barbour+T%22">Barbour T</searchLink>; Massachusetts General Hospital, Department of Psychiatry, Harvard Medical School, Boston, MA, USA.<br /><searchLink fieldCode="AU" term="%22Bjekić+J%22">Bjekić J</searchLink>; University of Belgrade, Institute for Medical Research, Human Neuroscience Group and Centre for Neuroscience and Neuromodulation Belgrade, Serbia.<br /><searchLink fieldCode="AU" term="%22Blumberger+DM%22">Blumberger DM</searchLink>; Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health and Department of Psychiatry, Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada.<br /><searchLink fieldCode="AU" term="%22Bolognini+N%22">Bolognini N</searchLink>; Department of Psychology, University of Milano Bicocca, and Laboratory of Neuropsychology, IRCCS Istituto Auxologico Italiano, Milano, Italy.<br /><searchLink fieldCode="AU" term="%22Brunelin+J%22">Brunelin J</searchLink>; CH Le Vinatier, Université Claude Bernard Lyon 1, CNRS, INSERM, Centre de Recherche en Neurosciences de Lyon CRNL, Bron, France.<br /><searchLink fieldCode="AU" term="%22Chanes+L%22">Chanes L</searchLink>; Department of Clinical and Health Psychology-Institute of Neurosciences, Universitat Autònoma de Barcelona, Barcelone, Spain.<br /><searchLink fieldCode="AU" term="%22Dale+M%22">Dale M</searchLink>; Magstim, Spring Gardens, Whitland, Carmarthenshire, SA34 0HR, UK.<br /><searchLink fieldCode="AU" term="%22Dubbioso+R%22">Dubbioso R</searchLink>; Neurophysiology Unit, Department of Neurosciences, Reproductive Sciences and Odontostomatology, University of Naples, Naples, Italy.<br /><searchLink fieldCode="AU" term="%22D'Urso+G%22">D'Urso G</searchLink>; Department of Neurosciences, Reproductive and Odontostomatological Sciences, University of Naples 'Federico II', Naples, Italy.<br /><searchLink fieldCode="AU" term="%22Filipcic+I%22">Filipcic I</searchLink>; Psychiatric Clinic 'Sveti Ivan', Zagreb, Croatia.<br /><searchLink fieldCode="AU" term="%22Filipović+SR%22">Filipović SR</searchLink>; University of Belgrade, Institute for Medical Research, Human Neuroscience Group and Centre for Neuroscience and Neuromodulation, Belgrade, Serbia.<br /><searchLink fieldCode="AU" term="%22Hirnstein+M%22">Hirnstein M</searchLink>; Department of Biological and Medical Psychology, University of Bergen, Bergen, Norway.<br /><searchLink fieldCode="AU" term="%22Konings+F%22">Konings F</searchLink>; Independent expert by experience contributor, Amsterdam, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Langguth+B%22">Langguth B</searchLink>; Chair of the German Society for Brain Stimulation in Psychiatry, Department of Psychiatry and Psychotherapy, Bezirksklinikum, University of Regensburg, Germany.<br /><searchLink fieldCode="AU" term="%22Leocani+L%22">Leocani L</searchLink>; Experimental Neurophysiology Unit, Institute of Experimental Neurology-INSPE, San Raffaele Scientific Institute, Milan, Italy; Faculty of Medicine, Vita-Salute San Raffaele University, Milan, Italy.<br /><searchLink fieldCode="AU" term="%22Sorkhabi+MM%22">Sorkhabi MM</searchLink>; Magstim, Spring Gardens, Whitland, Carmarthenshire SA34 0HR, UK.<br /><searchLink fieldCode="AU" term="%22Mulder+M%22">Mulder M</searchLink>; Independent expert by experience contributor, The Hague, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Nikander+M%22">Nikander M</searchLink>; Sooma Oy, Helsinki, Finland.<br /><searchLink fieldCode="AU" term="%22Nowak+R%22">Nowak R</searchLink>; Neuroelectrics, Barcelona, Catalonia, Spain.<br /><searchLink fieldCode="AU" term="%22Oliviero+A%22">Oliviero A</searchLink>; FENNSI Group, Hospital Nacional de PArapléjicos, SESCAM, Toledo, Spain; Center for Clinical Neuroscience - Hospital 'Los Madroños', Brunete (Madrid), Spain.<br /><searchLink fieldCode="AU" term="%22Onarheim+B%22">Onarheim B</searchLink>; School of Psychology and Humanities, University of Central Lancashire, U.K.<br /><searchLink fieldCode="AU" term="%22O'Shea+J%22">O'Shea J</searchLink>; Department of Psychiatry, University of Oxford, U.K.<br /><searchLink fieldCode="AU" term="%22Pallanti+S%22">Pallanti S</searchLink>; Istituto di Neuroscienze (Italy) and Albert Einstein College of Medicine (NY. USA) Chair of ECNP Network on Neuromodulation.<br /><searchLink fieldCode="AU" term="%22Rachid+F%22">Rachid F</searchLink>; Private Practice, 7, place de la Fusterie, 1204, Geneva, Switzerland.<br /><searchLink fieldCode="AU" term="%22Rajão-Saraiva+J%22">Rajão-Saraiva J</searchLink>; Independent expert by experience contributor, Coimbra, Portugal.<br /><searchLink fieldCode="AU" term="%22Rossi+S%22">Rossi S</searchLink>; Siena Brain Investigation and Neuromodulation Lab (SiBIN Lab), Department of Medicine, Surgery and Neuroscience, University of Siena, Italy.<br /><searchLink fieldCode="AU" term="%22Sack+AT%22">Sack AT</searchLink>; Section Brain Stimulation and Cognition, Department of Cognitive Neuroscience, Faculty of Psychology and Neuroscience, Maastricht University (UM); Department of Psychiatry and Neuropsychology, School for Mental Health and Neuroscience (MHeNs), Brain+Nerve Centre, Maastricht University Medical Center (MUMC+), Center for Integrative Neuroscience (CIN), the Netherlands.<br /><searchLink fieldCode="AU" term="%22Sauvaget+A%22">Sauvaget A</searchLink>; Department of Psychiatry, University Hospital of Nantes, France.<br /><searchLink fieldCode="AU" term="%22van+der+Scheer+R%22">van der Scheer R</searchLink>; Independent Patient Representative Advisor in Adult, Child & Adolescent Psychiatry, Venlo, the Netherlands.<br /><searchLink fieldCode="AU" term="%22Schellhorn+K%22">Schellhorn K</searchLink>; neuroConn GmbH, Ilmenau, Germany.<br /><searchLink fieldCode="AU" term="%22Soria-Frisch+A%22">Soria-Frisch A</searchLink>; Neuroscience BU, Starlab Barcelona, Spain.<br /><searchLink fieldCode="AU" term="%22Szekely+D%22">Szekely D</searchLink>; Deputy Head of Neuromodulation Unit of Princess Grace Hospital Centre, Monaco.<br /><searchLink fieldCode="AU" term="%22Tankisi+H%22">Tankisi H</searchLink>; Head of the Europa, Middle East, Africa Chapter of the International Federation of Clinical Neurophysiology, Department of Clinical Neurophysiology, Aarhus University Hospital and Department of Clinical Institute, Aarhus University, Aarhus, Denmark.<br /><searchLink fieldCode="AU" term="%22Cj+Taylor+P%22">Cj Taylor P</searchLink>; Department of Psychology, LMU Munich, Munich, Germany.<br /><searchLink fieldCode="AU" term="%22Tendolkar+I%22">Tendolkar I</searchLink>; Donders Institute for Brain, Cognition and Behavior, Department of Psychiatry, Radboud University Nijmegen, Netherlands.<br /><searchLink fieldCode="AU" term="%22Uusitalo+S%22">Uusitalo S</searchLink>; Philosophy (ethics), University of Oulu, Finland.<br /><searchLink fieldCode="AU" term="%22Baeken+C%22">Baeken C</searchLink>; Department of Head and Skin - Psychiatry and Medical Psychology, Ghent Experimental Psychiatry (GHEP) Lab, Ghent University, Ghent, Belgium; Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Department of Psychiatry, Brussels, Belgium; Department of Electrical Engineering, Eindhoven University of Technology, Eindhoven, the Netherlands.
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