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
José A Pineda-Pardo
HM CINAC MADRID (Centro Integral de Neurociencias Abarca Campal); Hospital Universitario HM Puerta del Sur, HM Hospitales. Madrid, Spain
James Coxon
Turner Institute for Brain and Mental Health, Monash University, Melbourne, Australia
Maja Friedemann
PhD
University of Oxford
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
Yoshikazu Ugawa
Fukushima Medical University
Nima Khalighinejad
University of Oxford
Noah Philip
MD
Center for Neurorestoration & Neurotechnology, VA Providence & Alpert Medical School of Brown University, Providence RI USA
James Choi
Imperial College London
Andrew Bishay
Semel Institute for Neuroscience and Human Behavior Department of Psychiatry & Biobehavioral Sciences University of California, Los Angeles
Raag D. Airan
Stanford University
Elisa Konofagou
Columbia University
Matthew Rushworth
University of Oxford
Pavlos Anastasiadis
Assistant Professor
University of Maryland
Lilian Aline Weber
Center for Cognitive Science, Osnabrueck University, Osnabrueck, Germany
William J Tyler
UAB Center for Neuroengineering and Brain Computer Interfaces
Ghazaleh Darmani
Krembil Research Institute, University of Toronto
Harriet Lea-Banks
University College London
W Apoutou N'Djin
Laboratory of Therapeutic Applications of Ultrasound (LabTAU), INSERM, University Claude Bernard of Lyon, France
Til Ole Bergmann
Neuroimaging Center (NIC), Johannes Gutenberg University Medical Center Mainz, Langenbeckstr. 1, 55131 Mainz, Germany
Antonios Pouliopoulos
King's College London
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
Ayache Bouakaz
Inserm iBraiN
Joseph Balfe
University of Oxford
Bradley E. Treeby
NeuroHarmonics LTD, 71-75 Shelton Street, Covent Garden, London, UK
Marco K Wittmann
University College London
Kevin A Caulfield
Department of Psychiatry, Medical University of South Carolina
Hairong Zheng
Sophie Morse
Dr
Imperial College London
Adam C Waspe
Hospital for Sick Children and University of Toronto
Benjamin Kop
Stanford University
Nader Saffari
University College London (UCL)
Sjoerd Meijer
Donders Institute
Francesco Prada
Istituto Neurologico C. Besta, Milano
Brooke Staveland
Postdoctoral Fellow
University of California, San Francisco
Sumner Norman
Forest Neurotech
Tyson Aflalo
Forest Neurotech
James McLaughlan
Dr
University of Leeds
Robert S Fisher
MD, PhD
Department of Neurology and Neurological Science, Stanford University School of Medicine
Maximilian Lueckel
M.Sc.
Leibniz Institute for Resilience Research (LIR) & Neuroimaging Center (NIC), Johannes Gutenberg University Medical Center, Mainz, Germany
Kenneth van der Zee
PhD Candidate
Donders Institute for Brain, Cognition, and Behaviour
Ying Meng
University of Toronto
Davide Martino
Department of Clinical Neuroscience & Hotchkiss Brain Institute, University of Calgary, Calgary, AB Canada
Gregory A. Fonzo, Ph.D.
Assistant Professor
The University of Texas at Austin Dell Medical School
Trevor Chong
Monash University
Ryan M. Jones
Physical Sciences Platform, Sunnybrook Research Institute, Toronto, ON, Canada
J Brian Fowlkes
PhD
Department of Radiology and Department of Biomedical Engineering, University of Michigan
Muhammad Zubair
Openwater
G Bruce Pike
University of Calgary
Vincent P Ferrera
Zuckerman Institute for Mind Brain and Behavior, Columbia University
Jean-Francois Aubry
Institute Physics for Medicine Paris – INSERM, CNRS, ESPCI Paris-PSL, Paris, France
Tom Matula
Director, Center for Industrial and Medical Ultrasound
Unhiversity of Washington
Eleanor Stride
University of Oxford
Alexander Bystritsky
CEO
Brainsonix
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
Oleg A Sapozhnikov
University of Washington, USA and Moscow State University, Russia
Kenneth Bader
University of Chicago
Julian Kosciessa
Postdoctoral Research Fellow
Donders Institute for Brain, Cognition, and Behaviour
Mary R Lee
MD
Veterans Affairs Medical Center, Washington DC
Rajiv Mahadevan
Attune Neurosciences
Eleanor Martin
Department of Medical Physics and Biomedical Engineering, University College London, London
David J Segar
Nudge
Estelle Raffin
Dr
CNRS, LPNC
David Norris
Radboud University, Donders Institute for Brain Cognition and Behaviour
Jeremy Barenholtz
Nudge
Merritt Maduke
Stanford University School of Medicine
Adam Harouak
Dr. med. univ.
Medical university of Vienna
Fady Girgis
University of Calgary
Joshua Marquez
Mr
King's College London
Martin Wimmers
TU/e EM4C&C; Donders Dnstitute for Brain Cognition and Behaviour Radboud University
Lei SUN
The Hong Kong Polytechnic University
Tulika Nandi
Vrije Universiteit Amsterdam
Julia Sophia Crone
University of Vienna; Paris Lodron University of Salzburg
Norman Spivak
UCLA
Mikhail G Shapiro
Max Delbrück Professor of Chemical & Medical Engineering at Caltech; Investigator at HHM
Li Min Chen
MD, PhD
Department of Radiology and Radiological Sciences, Institute of Imaging Science, Vanderbilt University Medical Center
Karin Roelofs
Donders Institute, Centre for Cognitive Neuroimaging, Radboud University Nijmegen, The Netherlands
Seung-Schik Yoo
Associate Professor, Department of Radiology, Brigham and Women's Hospital, Harvard Medical School
Ivan Toni
Donders Institute, Radboud University
Marcus Kaiser
Centre for Neurotechnology, Neuromodulation, and Neurotherapeutics, University of Nottingham and DeepBrain, United Kingdom
Camilla Nord
University of Cambridge, MRC Cognition and Brain Sciences Unit
Tatiana D. Khokhlova
Division of Gastroenterology, University of Washington School of Medicine Applied Physics Laboratory, University of Washington
Robert Chen
Krembil Research Institute and University of Toronto
Jean-Michel Escoffre
iBraiN, U1253, Inserm, Université de Tours, France
Daisy Thompson-Lake
Assistant Professor
University of Virginia
Vera A Khokhlova
University of Washington, USA and Moscow State University, Russia, D.Sc
Hartwig Roman Siebner
Danish Research Centre for Magnetic Resonance, Department of Radiology and Nuclear Medicine, Copenhagen University Hospital; Amager and Hvidovre
Shy Shoham
Tech4Health Institute and Departments of Neuroscience and of Ophthalmology, NYU Grossman School of Medicine
Seiki Konishi
Department of Neurophysiology, Juntendo University School of Medicine
Jan Kubanek
Psychiatry, Radiology, Neurology, and Biomedical Engineering; Washington University
Hanneke den Ouden
Professor
Donders Institute for Brain, Cognition and Behaviour, Radboud University, the Netherlands
Robin O. Cleveland
Institute of Biomedical Engineering, University of Oxford
Sebastian Reichstein
MSc
Donders Institute Nijmegen, the Netherlands
Kai Yu
Department of Biomedical Engineering, University of Connecticut
Emilie Franceschini
Aix-Marseille University, CNRS, LMA, Marseille
Carys Evans
Radboud University
Christopher Petkov
University of Iowa
Lisa Spiering
University of Oxford
Kim Butts Pauly
Stanford University
Mark Schafer
Rockefeller Neuroscience Institute, West Virginia University
Paul Boon
MD, PhD, FEAN
Ghent University, Belgium and Eindhoven University of Technology, The Netherlands