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
Brain Stimul. 2025 Jan 21:S1935-861X(25)00014-2.
doi: 10.1016/j.brs.2025.01.012.
Online ahead of print.
1 Department of Neurology, University Medical Center Göttingen, Germany. Electronic address: [email protected].
2 Department of Cognitive Neuroscience, Faculty of Psychology and Neuroscience, Maastricht University, Maastricht, The Netherlands.
3 Neuroimaging Center, Focus Program Translational Neuroscience, Johannes Gutenberg University Medical Center, Mainz, Germany; Leibniz Institute for Resilience Research (LIR), Mainz, Germany.
4 Human Neuroscience Group, Centre for Neuroscience and Neuromodulation, Institute for Medical Research, University of Belgrade, Serbia.
5 Center for Research in Neuropsychology and Cognitive Behavioral Intervention, Faculty of Psychology and Educational Sciences, University of Coimbra, Coimbra, Portugal.
6 Institute of Medical Psychology and Medical Sociology, University Medical Centre Schleswig-Holstein, Kiel University. Kiel, Germany.
7 Dept. Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund, Germany.
8 Department of Medicine, Surgery and Neuroscience, Siena Brain Investigation & Neuromodulation Lab (Si-BIN Lab), University of Siena, Italy.
9 Danish Research Centre for Magnetic Resonance, Centre for Functional and Diagnostic Imaging and Research, 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.
10 Department of Neurology, Ludwig-Maximilians University, Munich, Germany.
11 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.