Note of concern regarding the sources of scientific evidence used to justify the Reclassification of Non-Invasive Brain Stimulation (NIBS) Devices without an intended medical purpose into Class III

• Andrea Antal,
• Alexander T. Sack,
• Til Ole Bergmann,
• Jovana Bjekic,
• Saša R. Filipovic,
• Ana Ganho-Ávila,
• Vera Moliadze,
• Michael A. Nitsche,
• Simone Rossi,
• Teresa Schuhmann,
• Hartwig Siebner,
• Walter Paulus,
• Chris Baeken

Affiliations

Andrea Antal

Department of Neurology, University Medical Center Göttingen, Germany; Corresponding author. Department of Neurology, University Medical Center Göttingen, Robert Koch Str. 40, 37075, Göttingen, Germany.

Alexander T. Sack

Department of Cognitive Neuroscience, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, the Netherlands

Til Ole Bergmann

Neuroimaging Center, Focus Program Translational Neuroscience, Johannes Gutenberg University Medical Center, Mainz, Germany; Leibniz Institute for Resilience Research (LIR), Mainz, Germany

Jovana Bjekic

Human Neuroscience Group, Centre for Neuroscience and Neuromodulation, Institute for Medical Research, University of Belgrade, Serbia

Saša R. Filipovic

Human Neuroscience Group, Centre for Neuroscience and Neuromodulation, Institute for Medical Research, University of Belgrade, Serbia

Ana Ganho-Ávila

Center for Research in Neuropsychology and Cognitive Behavioral Intervention, Faculty of Psychology and Educational Sciences, University of Coimbra, Coimbra, Portugal

Vera Moliadze

Institute of Medical Psychology and Medical Sociology, University Medical Centre Schleswig-Holstein, Kiel University, Kiel, Germany

Michael A. Nitsche

Dept. Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund, Germany; University Clinic of Psychiatry and Psychotherapy, Protestant Hospital of Bethel Foundation, University Hospital OWL, Bielefeld University, Bielefeld, Germany; German Center for Mental Health (DZPG), Bochum, Germany

Simone Rossi

Department of Medicine, Surgery and Neuroscience, Siena Brain Investigation & Neuromodulation Lab (Si-BIN Lab), University of Siena, Italy

Teresa Schuhmann

Department of Cognitive Neuroscience, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, the Netherlands

Hartwig Siebner

Danish Research Centre for Magnetic Resonance, Department of Radiology and Nuclear Medicine, Copenhagen University Hospital Amager and Hvidovre, Copenhagen, Denmark; Department of Neurology, Copenhagen University Hospital Bispebjerg and Frederiksberg, Copenhagen, Denmark; Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark

Walter Paulus

Department of Neurology, Ludwig-Maximilians University, Munich, Germany

Chris Baeken

Faculty of Medicine and Health Sciences, Department of Head and Skin, Ghent Experimental Psychiatry (GHEP) lab, Ghent University, Ghent, Belgium; Neuroprotection and Neuromodulation Research Group (NEUR), Center for Neurosciences (C4N), Vrije Universiteit Brussel (VUB), Brussels, Belgium; Department of Psychiatry, Universitair Ziekenhuis Brussel (UZ Brussel), Brussels, Belgium; Center for Care and Cure Technology (C3Te), Department of Electrical Engineering, Eindhoven University of Technology, Eindhoven, the Netherlands