Open Letter on Intervention Regimes and Adverse Events in Focused Ultrasound for Neuromodulation
A community of researchers and clinicians in focused ultrasound neuromodulation has prepared an open letter on intervention regimes and safety reporting in this field. The letter was prompted by a recently reported adverse event in a clinical trial that used low-frequency ultrasound outside the low-intensity domain.
Its purpose is to provide a clear, broadly shared expert perspective on:
- how to distinguish low-, intermediate-, and high-intensity regimes,
- how cavitation risk should be assessed across these regimes, and
- how continued collaboration and detailed reporting can support safe development of this technology for the benefit of patients and the public.
If you wish to support this position, you are invited to add your name as a signatory below.
Support and sign the Open Letter
If you wish to show your support for this letter, please complete the signature form. By signing, you agree that your name and institutional affiliation may be displayed on a public list of signatories, demonstrating the breadth of support within the scientific, clinical, and broader focused ultrasound communities.
160 Signees
Til Ole Bergmann
Neuroimaging Center (NIC), Johannes Gutenberg University Medical Center Mainz, Langenbeckstr. 1, 55131 Mainz, Germany
Hao-Li Liu
Department of Electrical Engineering, National Taiwan University
Lisa Spiering
University of Oxford
Andrew Bishay
Semel Institute for Neuroscience and Human Behavior Department of Psychiatry & Biobehavioral Sciences University of California, Los Angeles
Christopher Petkov
University of Iowa
Karin Roelofs
Donders Institute, Centre for Cognitive Neuroimaging, Radboud University Nijmegen, The Netherlands
Kenneth Bader
University of Chicago
Tatiana D. Khokhlova
Division of Gastroenterology, University of Washington School of Medicine Applied Physics Laboratory, University of Washington
Marco K Wittmann
University College London
Sjoerd Meijer
Donders Institute
Robin O. Cleveland
Institute of Biomedical Engineering, University of Oxford
J Brian Fowlkes
PhD
Department of Radiology and Department of Biomedical Engineering, University of Michigan
Jonas Kielmann
Localite GmbH
Alexander Bystritsky
CEO
Brainsonix
Jean-Michel Escoffre
iBraiN, U1253, Inserm, Université de Tours, France
Jérôme Sallet JS
INSERM - University of Oxford
Dennis L Parker
Department of Radiology and Imaging Science, University of Utahs
Lei SUN
The Hong Kong Polytechnic University
Yaoheng Yang
University of Southern California
Robert Chen
Krembil Research Institute and University of Toronto
Sophie Morse
Dr
Imperial College London
Adam Harouak
Dr. med. univ.
Medical university of Vienna
Kim Butts Pauly
Stanford University
Julia Sophia Crone
University of Vienna; Paris Lodron University of Salzburg
James McLaughlan
Dr
University of Leeds
Mikhail G Shapiro
Max Delbrück Professor of Chemical & Medical Engineering at Caltech; Investigator at HHM
Wynn Legon
Fralin Biomedical Research Institute at Virginia Tech Carilion
Daniel Whitcomb
University of Bristol
Chris Butler
Department of Brain Sciences, Imperial College London
Bin He
Department of Biomedical Engineering, Carnegie Mellon University
Wayne Kreider
University of Washington, USA
Takahiro Osada
Department of Neurophysiology, Juntendo University School of Medicine
Sumner Norman
Forest Neurotech
Maja Friedemann
PhD
University of Oxford
Jeremy Barenholtz
Nudge
Charlotte Reese Marshall
Assistant Professor
University of Birmingham
Tulika Nandi
Vrije Universiteit Amsterdam
Lawrence A Crum
University of Washington
Thomas Paul
PhD Student
Ecole Polytechnique F�d�rale de Lausanne
Shy Shoham
Tech4Health Institute and Departments of Neuroscience and of Ophthalmology, NYU Grossman School of Medicine
William J Tyler
UAB Center for Neuroengineering and Brain Computer Interfaces
Camilla Nord
University of Cambridge, MRC Cognition and Brain Sciences Unit
Til Ole Bergmann
Prof. Dr.
Johannes Gutenberg University Medical Center Mainz, Germany
Ruggero Condorelli
Research Assistant
Donders Centre for Cognition
Miriam C Klein-Flugge
Oxford Centre for Integrative Neuroimaging, Department of Experimental Psychology, University of Oxford, Oxford OX1 3EL, United Kingdom; Department of Psychiatry,Warneford Hospital, University of Oxford, Oxford OX3 7JX, United Kingdom
Harriet Lea-Banks
University College London
Cyril LAFON
INSERM LabTAU
Raag D. Airan
Stanford University
Benjamin Kop
Stanford University
Hanneke den Ouden
Professor
Donders Institute for Brain, Cognition and Behaviour, Radboud University, the Netherlands
Kevin A Caulfield
Department of Psychiatry, Medical University of South Carolina
Eleanor Stride
University of Oxford
Ellen J Bubrick
Brigham and Women's Hospital, Department of Neurology, Harvard Medical School
Keith R. Murphy
Attune Neurosciences, San Francisco, CA, U.S.A.
Robert S Fisher
MD, PhD
Department of Neurology and Neurological Science, Stanford University School of Medicine
Davide Martino
Department of Clinical Neuroscience & Hotchkiss Brain Institute, University of Calgary, Calgary, AB Canada
Merritt Maduke
Stanford University School of Medicine
Mark Schafer
Rockefeller Neuroscience Institute, West Virginia University
Sebastian Reichstein
MSc
Donders Institute Nijmegen, the Netherlands
Leo P Sugrue
MD, PhD
University of California, San Francisco
Maxime Lafond
Laboratory of Therapeutic Applications of Ultrasound, LabTAU, Inserm U1032, Lyon, France
James Choi
Imperial College London
Tyson Aflalo
Forest Neurotech
Noah Philip
MD
Center for Neurorestoration & Neurotechnology, VA Providence & Alpert Medical School of Brown University, Providence RI USA
Taylor Webb
Department of Radiology and Imaging Sciences, University of Utah
Matthew Rushworth
University of Oxford
Erno Hermans
Donders Institute for Brain, Cognition and Behaviour
Emilie Franceschini
Aix-Marseille University, CNRS, LMA, Marseille
Tom Matula
Director, Center for Industrial and Medical Ultrasound
Unhiversity of Washington
Niklas Kroner-Weigl
Max Planck Institute for Human Cognitive and Brain Sciences, Leipzig, Germany
Eleanor Martin
Department of Medical Physics and Biomedical Engineering, University College London, London
Pavlos Anastasiadis
Assistant Professor
University of Maryland
Yasuo Terao
Department of Medical Physiology, Kyorin University
Yoshikazu Ugawa
Fukushima Medical University
José A Pineda-Pardo
HM CINAC MADRID (Centro Integral de Neurociencias Abarca Campal); Hospital Universitario HM Puerta del Sur, HM Hospitales. Madrid, Spain
Maximilian Lueckel
M.Sc.
Leibniz Institute for Resilience Research (LIR) & Neuroimaging Center (NIC), Johannes Gutenberg University Medical Center, Mainz, Germany
Adam C Waspe
Hospital for Sick Children and University of Toronto
Ivan Suarez-Castellano
PhD
Laboratory of Therapeutic Applications of Ultrasound (LabTAU), INSERM U1032, Lyon, France.
Vincent P Ferrera
Zuckerman Institute for Mind Brain and Behavior, Columbia University
Nima Khalighinejad
University of Oxford
Gianmarco Pinton
Joint Department of Biomedical Engineering, University of North Carolina at Chapel Hill & North, Carolina State University
David J Segar
Nudge
James Hong
Academic Clinical Fellow in psychiatry
Department of Psychiatry, University of Oxford
Andres Lozano
Division of Neurosurgery, University Health Network and University of Toronto
Martin Wimmers
TU/e EM4C&C; Donders Dnstitute for Brain Cognition and Behaviour Radboud University
Elena Andres
Dr.
Leibniz Institute for Resilience Research
Nader Saffari
University College London (UCL)
Fady Girgis
University of Calgary
Marcus Kaiser
Centre for Neurotechnology, Neuromodulation, and Neurotherapeutics, University of Nottingham and DeepBrain, United Kingdom
Paul Boon
MD, PhD, FEAN
Ghent University, Belgium and Eindhoven University of Technology, The Netherlands
Gregory A. Fonzo, Ph.D.
Assistant Professor
The University of Texas at Austin Dell Medical School
Cyril Atkinson-Clement
Brain Research and Imaging Centre, Faculty of Health, University of Plymouth, Plymouth PL6 8BU, United Kingdom.
Suhas Vijayakumar
Neuroimaging Center, Johannes Gutenberg University Medical Center, Mainz
Hairong Zheng
Nadège Bault
University of Plymouth, UK
Ivan Toni
Donders Institute, Radboud University
Estelle Raffin
Dr
CNRS, LPNC
Elsa F. Fouragnan
School of Psychology, Faculty of Health, University of Plymouth, UK; Brain Research Imaging Center, Faculty of Health, University of Plymouth, UK
Hartwig Roman Siebner
Danish Research Centre for Magnetic Resonance, Department of Radiology and Nuclear Medicine, Copenhagen University Hospital; Amager and Hvidovre
James Coxon
Turner Institute for Brain and Mental Health, Monash University, Melbourne, Australia