Evidence map›Paper›PMID 38679530›Full record

ArticleClinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology2024

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.

Andrea Antal, Ana Ganho-Ávila, Sara Assecondi, Tracy Barbour, Jovana Bjekić, Daniel M Blumberger, Nadia Bolognini, Jerome Brunelin, Lorena Chanes, Matthew Dale and 30 more

Abstract read
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In one paragraph

Article in Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Review
  4. Long-term use of tDCS-clinical and ethical considerations.Frontiers in human neuroscience · 2026
    Article
  5. Review
  6. Review
  7. Review
  8. A Horizon Scan of Neurotechnology Innovations.International journal of environmental research and public health · 2025
    Review
  9. Article
  10. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

40 authors.

Andrea AntalDepartment of Neurology, University Medical Center Göttingen, Göttingen. Germany. Electronic address: aantal@gwdg.de.
Ana Ganho-ÁvilaCenter for Research in Neuropsychology and Cognitive Behavioral Intervention, Faculty of Psychology and Educational Sciences, University of Coimbra, Coimbra, Portugal.
Sara AssecondiCentre for Mind/Brain Sciences - CIMeC, University of Trento, Rovereto (TN), Italy.
Tracy BarbourMassachusetts General Hospital, Department of Psychiatry, Harvard Medical School, Boston, MA, USA.
Jovana BjekićUniversity of Belgrade, Institute for Medical Research, Human Neuroscience Group and Centre for Neuroscience and Neuromodulation Belgrade, Serbia.
Daniel M BlumbergerTemerty 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.
Nadia BologniniDepartment of Psychology, University of Milano Bicocca, and Laboratory of Neuropsychology, IRCCS Istituto Auxologico Italiano, Milano, Italy.
Jerome BrunelinCH Le Vinatier, Université Claude Bernard Lyon 1, CNRS, INSERM, Centre de Recherche en Neurosciences de Lyon CRNL, Bron, France.
Lorena ChanesDepartment of Clinical and Health Psychology-Institute of Neurosciences, Universitat Autònoma de Barcelona, Barcelone, Spain.
Matthew DaleMagstim, Spring Gardens, Whitland, Carmarthenshire, SA34 0HR, UK.
Raffaele DubbiosoNeurophysiology Unit, Department of Neurosciences, Reproductive Sciences and Odontostomatology, University of Naples, Naples, Italy.
Giordano D'UrsoDepartment of Neurosciences, Reproductive and Odontostomatological Sciences, University of Naples "Federico II", Naples, Italy.
Igor FilipcicPsychiatric Clinic 'Sveti Ivan', Zagreb, Croatia.
Saša R FilipovićUniversity of Belgrade, Institute for Medical Research, Human Neuroscience Group and Centre for Neuroscience and Neuromodulation, Belgrade, Serbia.
Marco HirnsteinDepartment of Biological and Medical Psychology, University of Bergen, Bergen, Norway.
Femke KoningsIndependent expert by experience contributor, Amsterdam, the Netherlands.
Berthold LangguthChair of the German Society for Brain Stimulation in Psychiatry, Department of Psychiatry and Psychotherapy, Bezirksklinikum, University of Regensburg, Germany.
Letizia LeocaniExperimental Neurophysiology Unit, Institute of Experimental Neurology-INSPE, San Raffaele Scientific Institute, Milan, Italy; Faculty of Medicine, Vita-Salute San Raffaele University, Milan, Italy.
Majid Memarian SorkhabiMagstim, Spring Gardens, Whitland, Carmarthenshire SA34 0HR, UK.
Marc MulderIndependent expert by experience contributor, The Hague, the Netherlands.
Mika NikanderSooma Oy, Helsinki, Finland.
Rafal NowakNeuroelectrics, Barcelona, Catalonia, Spain.
Antonio OlivieroFENNSI Group, Hospital Nacional de PArapléjicos, SESCAM, Toledo, Spain; Center for Clinical Neuroscience - Hospital "Los Madroños", Brunete (Madrid), Spain.
Balder OnarheimSchool of Psychology and Humanities, University of Central Lancashire, U.K.
Jacinta O'SheaDepartment of Psychiatry, University of Oxford, U.K.
Stefano PallantiIstituto di Neuroscienze (Italy) and Albert Einstein College of Medicine (NY. USA) Chair of ECNP Network on Neuromodulation.
Fady RachidPrivate Practice, 7, place de la Fusterie, 1204, Geneva, Switzerland.
Joana Rajão-SaraivaIndependent expert by experience contributor, Coimbra, Portugal.
Simone RossiSiena Brain Investigation and Neuromodulation Lab (SiBIN Lab), Department of Medicine, Surgery and Neuroscience, University of Siena, Italy.
Alexander T SackSection 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.
Anne SauvagetDepartment of Psychiatry, University Hospital of Nantes, France.
Rik van der ScheerIndependent Patient Representative Advisor in Adult, Child & Adolescent Psychiatry, Venlo, the Netherlands.
Klaus SchellhornneuroConn GmbH, Ilmenau, Germany.
Aureli Soria-FrischNeuroscience BU, Starlab Barcelona, Spain.
David SzekelyDeputy Head of Neuromodulation Unit of Princess Grace Hospital Centre, Monaco.
Hatice TankisiHead 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.
Paul Cj TaylorDepartment of Psychology, LMU Munich, Munich, Germany.
Indira TendolkarDonders Institute for Brain, Cognition and Behavior, Department of Psychiatry, Radboud University Nijmegen, Netherlands.
Susanne UusitaloPhilosophy (ethics), University of Oulu, Finland.
Chris BaekenDepartment 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.

Funding

Wellcome Trust 215451
6 · The paper itself

Abstract

A significant amount of European basic and clinical neuroscience research includes the use of transcranial magnetic stimulation (TMS) and low intensity transcranial electrical stimulation (tES), mainly transcranial direct current stimulation (tDCS). Two recent changes in the EU regulations, the introduction of the Medical Device Regulation (MDR) (2017/745) and the Annex XVI have caused significant problems and confusions in the brain stimulation field. The negative consequences of the MDR for non-invasive brain stimulation (NIBS) have been largely overlooked and until today, have not been consequently addressed by National Competent Authorities, local ethical committees, politicians and by the scientific communities. In addition, a rushed bureaucratic decision led to seemingly wrong classification of NIBS products without an intended medical purpose into the same risk group III as invasive stimulators. Overregulation is detrimental for any research and for future developments, therefore researchers, clinicians, industry, patient representatives and an ethicist were invited to contribute to this document with the aim of starting a constructive dialogue and enacting positive changes in the regulatory environment.

Indexed as

Transcranial Direct Current StimulationTranscranial Magnetic StimulationBiomedical ResearchDevice ApprovalEuropeEuropean UnionHumansMedical Device LegislationBrain stimulationMedical device regulationReclassification

Identifiers

PMID38679530
PMCPMC7618791

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.