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
James McLaughlan
Dr
University of Leeds
Muhammad Zubair
Openwater
Joseph Balfe
University of Oxford
Ellen J Bubrick
Brigham and Women's Hospital, Department of Neurology, Harvard Medical School
Til Ole Bergmann
Prof. Dr.
Johannes Gutenberg University Medical Center Mainz, Germany
Maximilian Lueckel
M.Sc.
Leibniz Institute for Resilience Research (LIR) & Neuroimaging Center (NIC), Johannes Gutenberg University Medical Center, Mainz, Germany
Maxime Lafond
Laboratory of Therapeutic Applications of Ultrasound, LabTAU, Inserm U1032, Lyon, France
Hartwig Roman Siebner
Danish Research Centre for Magnetic Resonance, Department of Radiology and Nuclear Medicine, Copenhagen University Hospital; Amager and Hvidovre
Seiki Konishi
Department of Neurophysiology, Juntendo University School of Medicine
Alexander Bystritsky
CEO
Brainsonix
Marco K Wittmann
University College London
Marcus Kaiser
Centre for Neurotechnology, Neuromodulation, and Neurotherapeutics, University of Nottingham and DeepBrain, United Kingdom
Niklas Kroner-Weigl
Max Planck Institute for Human Cognitive and Brain Sciences, Leipzig, Germany
Kai Yu
Department of Biomedical Engineering, University of Connecticut
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-Michel Escoffre
iBraiN, U1253, Inserm, Université de Tours, France
James Coxon
Turner Institute for Brain and Mental Health, Monash University, Melbourne, Australia
Estelle Raffin
Dr
CNRS, LPNC
Camilla Nord
University of Cambridge, MRC Cognition and Brain Sciences Unit
Suhas Vijayakumar
Neuroimaging Center, Johannes Gutenberg University Medical Center, Mainz
Marwan Engels
Donders Institute
Lei SUN
The Hong Kong Polytechnic University
Oleg A Sapozhnikov
University of Washington, USA and Moscow State University, Russia
Sebastian Reichstein
MSc
Donders Institute Nijmegen, the Netherlands
Jean-Francois Aubry
Institute Physics for Medicine Paris – INSERM, CNRS, ESPCI Paris-PSL, Paris, France
Bin He
Department of Biomedical Engineering, Carnegie Mellon University
Jan Kubanek
Psychiatry, Radiology, Neurology, and Biomedical Engineering; Washington University
Kevin A Caulfield
Department of Psychiatry, Medical University of South Carolina
Sumner Norman
Forest Neurotech
Paul Boon
MD, PhD, FEAN
Ghent University, Belgium and Eindhoven University of Technology, The Netherlands
Bradley E. Treeby
NeuroHarmonics LTD, 71-75 Shelton Street, Covent Garden, London, UK
Johannes Algermissen
University of Zurich
David Norris
Radboud University, Donders Institute for Brain Cognition and Behaviour
Kenneth Bader
University of Chicago
Joshua Marquez
Mr
King's College London
Nader Saffari
University College London (UCL)
Carys Evans
Radboud University
Pavlos Anastasiadis
Assistant Professor
University of Maryland
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
Fady Girgis
University of Calgary
Francesco Prada
Istituto Neurologico C. Besta, Milano
Emilie Franceschini
Aix-Marseille University, CNRS, LMA, Marseille
Tommaso Di Ianni
PhD
University of California San Francisco
Hairong Zheng
David Attali
Unité de Neuropsychiatrie Interventionnelle, Hôpital Sainte-Anne, GHU Paris Psychiatrie & Neurosciences, Université Paris Cité, 75014 Paris, France; Institute Physics for Medicine Paris, Inserm U1273, ESPCI Paris, PSL University, CNRS UMR 8063, 75015 Paris, France
Pierre Pouget
ICM Paris Brain Institute, CNRS
Robin O. Cleveland
Institute of Biomedical Engineering, University of Oxford
Sophie Morse
Dr
Imperial College London
Ayache Bouakaz
Inserm iBraiN
Andrew Bishay
Semel Institute for Neuroscience and Human Behavior Department of Psychiatry & Biobehavioral Sciences University of California, Los Angeles
Julia Sophia Crone
University of Vienna; Paris Lodron University of Salzburg
Antonios Pouliopoulos
King's College London
W Apoutou N'Djin
Laboratory of Therapeutic Applications of Ultrasound (LabTAU), INSERM, University Claude Bernard of Lyon, France
Rajiv Mahadevan
Attune Neurosciences
Yunzhe Liu
Beijing Normal University
Adam C Waspe
Hospital for Sick Children and University of Toronto
Yaoheng Yang
University of Southern California
Benjamin Kop
Stanford University
Eleanor Stride
University of Oxford
Norman Spivak
UCLA
Raag D. Airan
Stanford University
Jonas Kielmann
Localite GmbH
Erik Dumont
CEO, Image Guided Therapy, France
Martin Wimmers
TU/e EM4C&C; Donders Dnstitute for Brain Cognition and Behaviour Radboud University
Harriet Lea-Banks
University College London
Keith R. Murphy
Attune Neurosciences, San Francisco, CA, U.S.A.
Davide Martino
Department of Clinical Neuroscience & Hotchkiss Brain Institute, University of Calgary, Calgary, AB Canada
Ryan T Ash
MD, PhD
Department of Psychiatry and Behavioral Sciences, University of California San Francisco
Leo P Sugrue
MD, PhD
University of California, San Francisco
Kim Butts Pauly
Stanford University
G Bruce Pike
University of Calgary
Matthew Rushworth
University of Oxford
Robert Chen
Krembil Research Institute and University of Toronto
Dennis L Parker
Department of Radiology and Imaging Science, University of Utahs
Mark Schafer
Rockefeller Neuroscience Institute, West Virginia University
Junfeng Sun
Professor
Shanghai Jiao Tong University
James Choi
Imperial College London
Trevor Chong
Monash University
Adam Harouak
Dr. med. univ.
Medical university of Vienna
Chris Butler
Department of Brain Sciences, Imperial College London
Tom Matula
Director, Center for Industrial and Medical Ultrasound
Unhiversity of Washington
Lennart Verhagen
Donders Institute for Brain, Cognition and Behaviour, Radboud University, 6525 GD, Nijmegen, the Netherlands
Robert S Fisher
MD, PhD
Department of Neurology and Neurological Science, Stanford University School of Medicine
Kenneth van der Zee
PhD Candidate
Donders Institute for Brain, Cognition, and Behaviour
Ghazaleh Darmani
Krembil Research Institute, University of Toronto
Ruggero Condorelli
Research Assistant
Donders Centre for Cognition
Mark Palmeri
M.D, Ph.D
Duke University, Department of Biomedical Engineering
Arno Villringer
Max Planck Institute for Human Cognitive and Brain Sciences
Nadège Bault
University of Plymouth, UK
Gregory A. Fonzo, Ph.D.
Assistant Professor
The University of Texas at Austin Dell Medical School
Seung-Schik Yoo
Associate Professor, Department of Radiology, Brigham and Women's Hospital, Harvard Medical School
Charles F. Caskey
Vanderbilt University Medical Center
Mary R Lee
MD
Veterans Affairs Medical Center, Washington DC
Ying Meng
University of Toronto
Soren Konecky
CTO
Openwater
Elsa F. Fouragnan
School of Psychology, Faculty of Health, University of Plymouth, UK; Brain Research Imaging Center, Faculty of Health, University of Plymouth, UK
Jérôme Sallet JS
INSERM - University of Oxford
Lawrence A Crum
University of Washington
Vincent P Ferrera
Zuckerman Institute for Mind Brain and Behavior, Columbia University
William J Tyler
UAB Center for Neuroengineering and Brain Computer Interfaces