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
Maja Friedemann
PhD
University of Oxford
Elena Andres
Dr.
Leibniz Institute for Resilience Research
Mark Schafer
Rockefeller Neuroscience Institute, West Virginia University
Eva Feredoes
Dr
University of Reading
Gianmarco Pinton
Joint Department of Biomedical Engineering, University of North Carolina at Chapel Hill & North, Carolina State University
James Coxon
Turner Institute for Brain and Mental Health, Monash University, Melbourne, Australia
Emilie Franceschini
Aix-Marseille University, CNRS, LMA, Marseille
Erik Dumont
CEO, Image Guided Therapy, France
Sebastian Reichstein
MSc
Donders Institute Nijmegen, the Netherlands
Matthew Rushworth
University of Oxford
Ellen J Bubrick
Brigham and Women's Hospital, Department of Neurology, Harvard Medical School
Adam Harouak
Dr. med. univ.
Medical university of Vienna
Johannes Algermissen
University of Zurich
Shy Shoham
Tech4Health Institute and Departments of Neuroscience and of Ophthalmology, NYU Grossman School of Medicine
José A Pineda-Pardo
HM CINAC MADRID (Centro Integral de Neurociencias Abarca Campal); Hospital Universitario HM Puerta del Sur, HM Hospitales. Madrid, Spain
Fady Girgis
University of Calgary
Merritt Maduke
Stanford University School of Medicine
Antonios Pouliopoulos
King's College London
Suhas Vijayakumar
Neuroimaging Center, Johannes Gutenberg University Medical Center, Mainz
Daniel Whitcomb
University of Bristol
J Brian Fowlkes
PhD
Department of Radiology and Department of Biomedical Engineering, University of Michigan
Hao-Li Liu
Department of Electrical Engineering, National Taiwan University
Andrew Bishay
Semel Institute for Neuroscience and Human Behavior Department of Psychiatry & Biobehavioral Sciences University of California, Los Angeles
Wayne Kreider
University of Washington, USA
Jean-Michel Escoffre
iBraiN, U1253, Inserm, Université de Tours, France
Carys Evans
Radboud University
Kim Butts Pauly
Stanford University
Li Min Chen
MD, PhD
Department of Radiology and Radiological Sciences, Institute of Imaging Science, Vanderbilt University Medical Center
Muhammad Zubair
Openwater
Leo P Sugrue
MD, PhD
University of California, San Francisco
Ying Meng
University of Toronto
Pierre Pouget
ICM Paris Brain Institute, CNRS
Ryan T Ash
MD, PhD
Department of Psychiatry and Behavioral Sciences, University of California San Francisco
Charlotte Reese Marshall
Assistant Professor
University of Birmingham
Arno Villringer
Max Planck Institute for Human Cognitive and Brain Sciences
Seiki Konishi
Department of Neurophysiology, Juntendo University School of Medicine
Lei SUN
The Hong Kong Polytechnic University
Tommaso Di Ianni
PhD
University of California San Francisco
Ghazaleh Darmani
Krembil Research Institute, University of Toronto
David J Segar
Nudge
Cyril LAFON
INSERM LabTAU
Yunzhe Liu
Beijing Normal University
Maxime Lafond
Laboratory of Therapeutic Applications of Ultrasound, LabTAU, Inserm U1032, Lyon, France
Soren Konecky
CTO
Openwater
Lisa Spiering
University of Oxford
Wynn Legon
Fralin Biomedical Research Institute at Virginia Tech Carilion
Andres Lozano
Division of Neurosurgery, University Health Network and University of Toronto
Til Ole Bergmann
Prof. Dr.
Johannes Gutenberg University Medical Center Mainz, Germany
Hartwig Roman Siebner
Danish Research Centre for Magnetic Resonance, Department of Radiology and Nuclear Medicine, Copenhagen University Hospital; Amager and Hvidovre
Samuel Pichardo
Radiology and Clinical Neurosciences, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary
Yasuo Terao
Department of Medical Physiology, Kyorin University
Francesco Prada
Istituto Neurologico C. Besta, Milano
Lennart Verhagen
Donders Institute for Brain, Cognition and Behaviour, Radboud University, 6525 GD, Nijmegen, the Netherlands
James Choi
Imperial College London
Raag D. Airan
Stanford University
Alexander Bystritsky
CEO
Brainsonix
Marco K Wittmann
University College London
Rajiv Mahadevan
Attune Neurosciences
Joseph Balfe
University of Oxford
Karin Roelofs
Donders Institute, Centre for Cognitive Neuroimaging, Radboud University Nijmegen, The Netherlands
Benjamin Kop
Stanford University
Sophie Morse
Dr
Imperial College London
Maximilian Lueckel
M.Sc.
Leibniz Institute for Resilience Research (LIR) & Neuroimaging Center (NIC), Johannes Gutenberg University Medical Center, Mainz, Germany
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
Jean-Francois Aubry
Institute Physics for Medicine Paris – INSERM, CNRS, ESPCI Paris-PSL, Paris, France
Kenneth van der Zee
PhD Candidate
Donders Institute for Brain, Cognition, and Behaviour
Julia Sophia Crone
University of Vienna; Paris Lodron University of Salzburg
Eleanor Martin
Department of Medical Physics and Biomedical Engineering, University College London, London
Axel Thielscher
Technical Unversity of Denmark & Danish Research Centre for MR
Hairong Zheng
Estelle Raffin
Dr
CNRS, LPNC
Mary R Lee
MD
Veterans Affairs Medical Center, Washington DC
Til Ole Bergmann
Neuroimaging Center (NIC), Johannes Gutenberg University Medical Center Mainz, Langenbeckstr. 1, 55131 Mainz, Germany
Ryan M. Jones
Physical Sciences Platform, Sunnybrook Research Institute, Toronto, ON, Canada
Christopher R Bawiec
Prophetic
Seung-Schik Yoo
Associate Professor, Department of Radiology, Brigham and Women's Hospital, Harvard Medical School
Vincent P Ferrera
Zuckerman Institute for Mind Brain and Behavior, Columbia University
James McLaughlan
Dr
University of Leeds
Nadège Bault
University of Plymouth, UK
Elsa F. Fouragnan
School of Psychology, Faculty of Health, University of Plymouth, UK; Brain Research Imaging Center, Faculty of Health, University of Plymouth, UK
Brooke Staveland
Postdoctoral Fellow
University of California, San Francisco
Mikhail G Shapiro
Max Delbrück Professor of Chemical & Medical Engineering at Caltech; Investigator at HHM
Charles F. Caskey
Vanderbilt University Medical Center
Tom Matula
Director, Center for Industrial and Medical Ultrasound
Unhiversity of Washington
Adam C Waspe
Hospital for Sick Children and University of Toronto
Takahiro Osada
Department of Neurophysiology, Juntendo University School of Medicine
Nader Saffari
University College London (UCL)
William J Tyler
UAB Center for Neuroengineering and Brain Computer Interfaces
Sumner Norman
Forest Neurotech
Bin He
Department of Biomedical Engineering, Carnegie Mellon University
Harriet Lea-Banks
Department of Medical Physics and Biomedical Engineering, University College London, London, UK; UCL Centre for Advanced Biomedical Imaging, Division of Medicine, University College London, London, UK
Roshan Cools
Professor of Cognitive Neuropsychiatry
Donders Institute for Brain, Cognition and Behaviour, Centre for Cognitive Neuroimaging; Radboud university medical Center, Department of Psychiatry, Nijmegen
Sjoerd Meijer
Donders Institute
Niklas Kroner-Weigl
Max Planck Institute for Human Cognitive and Brain Sciences, Leipzig, Germany
Jérôme Sallet JS
INSERM - University of Oxford
Mark Palmeri
M.D, Ph.D
Duke University, Department of Biomedical Engineering
Robert Chen
Krembil Research Institute and University of Toronto
James Hong
Academic Clinical Fellow in psychiatry
Department of Psychiatry, University of Oxford
Marwan Engels
Donders Institute
Kevin A Caulfield
Department of Psychiatry, Medical University of South Carolina