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
Wayne Kreider
University of Washington, USA
William J Tyler
UAB Center for Neuroengineering and Brain Computer Interfaces
Hanneke den Ouden
Professor
Donders Institute for Brain, Cognition and Behaviour, Radboud University, the Netherlands
Adam C Waspe
Hospital for Sick Children and University of Toronto
Seung-Schik Yoo
Associate Professor, Department of Radiology, Brigham and Women's Hospital, Harvard Medical School
Ying Meng
University of Toronto
Harriet Lea-Banks
University College London
Nadège Bault
University of Plymouth, UK
James McLaughlan
Dr
University of Leeds
Ryan M. Jones
Physical Sciences Platform, Sunnybrook Research Institute, Toronto, ON, Canada
James Hong
Academic Clinical Fellow in psychiatry
Department of Psychiatry, University of Oxford
Marco K Wittmann
University College London
Elisa Konofagou
Columbia University
Ghazaleh Darmani
Krembil Research Institute, University of Toronto
J Brian Fowlkes
PhD
Department of Radiology and Department of Biomedical Engineering, University of Michigan
Estelle Raffin
Dr
CNRS, LPNC
Vera A Khokhlova
University of Washington, USA and Moscow State University, Russia, D.Sc
Mark Palmeri
M.D, Ph.D
Duke University, Department of Biomedical Engineering
Matthew Rushworth
University of Oxford
Camilla Nord
University of Cambridge, MRC Cognition and Brain Sciences Unit
Sophie Morse
Dr
Imperial College London
Julia Sophia Crone
University of Vienna; Paris Lodron University of Salzburg
Noah Philip
MD
Center for Neurorestoration & Neurotechnology, VA Providence & Alpert Medical School of Brown University, Providence RI USA
Soren Konecky
CTO
Openwater
David Norris
Radboud University, Donders Institute for Brain Cognition and Behaviour
Marwan Engels
Donders Institute
Eleanor Martin
Department of Medical Physics and Biomedical Engineering, University College London, London
Alexander Bystritsky
CEO
Brainsonix
Tatiana D. Khokhlova
Division of Gastroenterology, University of Washington School of Medicine Applied Physics Laboratory, University of Washington
Ryan T Ash
MD, PhD
Department of Psychiatry and Behavioral Sciences, University of California San Francisco
Ayache Bouakaz
Inserm iBraiN
Daniel Whitcomb
University of Bristol
Daisy Thompson-Lake
Assistant Professor
University of Virginia
Tyson Aflalo
Forest Neurotech
Cyril Atkinson-Clement
Brain Research and Imaging Centre, Faculty of Health, University of Plymouth, Plymouth PL6 8BU, United Kingdom.
Mark Schafer
Rockefeller Neuroscience Institute, West Virginia University
José A Pineda-Pardo
HM CINAC MADRID (Centro Integral de Neurociencias Abarca Campal); Hospital Universitario HM Puerta del Sur, HM Hospitales. Madrid, Spain
Martin Wimmers
TU/e EM4C&C; Donders Dnstitute for Brain Cognition and Behaviour Radboud University
Tommaso Di Ianni
PhD
University of California San Francisco
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
Kenneth Bader
University of Chicago
Dennis L Parker
Department of Radiology and Imaging Science, University of Utahs
Davide Martino
Department of Clinical Neuroscience & Hotchkiss Brain Institute, University of Calgary, Calgary, AB Canada
Axel Thielscher
Technical Unversity of Denmark & Danish Research Centre for MR
Nader Saffari
University College London (UCL)
Leo P Sugrue
MD, PhD
University of California, San Francisco
Joshua Marquez
Mr
King's College London
Yasuo Terao
Department of Medical Physiology, Kyorin University
Charlotte Reese Marshall
Assistant Professor
University of Birmingham
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
Robin O. Cleveland
Institute of Biomedical Engineering, University of Oxford
Lilian Aline Weber
Center for Cognitive Science, Osnabrueck University, Osnabrueck, Germany
Vincent P Ferrera
Zuckerman Institute for Mind Brain and Behavior, Columbia University
Christopher R Bawiec
Prophetic
Til Ole Bergmann
Prof. Dr.
Johannes Gutenberg University Medical Center Mainz, Germany
James Choi
Imperial College London
Lawrence A Crum
University of Washington
Chris Butler
Department of Brain Sciences, Imperial College London
Muhammad Zubair
Openwater
Ivan Suarez-Castellano
PhD
Laboratory of Therapeutic Applications of Ultrasound (LabTAU), INSERM U1032, Lyon, France.
Fady Girgis
University of Calgary
Eleanor Stride
University of Oxford
Til Ole Bergmann
Neuroimaging Center (NIC), Johannes Gutenberg University Medical Center Mainz, Langenbeckstr. 1, 55131 Mainz, Germany
Ruggero Condorelli
Research Assistant
Donders Centre for Cognition
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
Brooke Staveland
Postdoctoral Fellow
University of California, San Francisco
Adam Harouak
Dr. med. univ.
Medical university of Vienna
Seiki Konishi
Department of Neurophysiology, Juntendo University School of Medicine
Andres Lozano
Division of Neurosurgery, University Health Network and University of Toronto
Lennart Verhagen
Donders Institute for Brain, Cognition and Behaviour, Radboud University, 6525 GD, Nijmegen, the Netherlands
Arno Schmitgen
Localite GmbH
Li Min Chen
MD, PhD
Department of Radiology and Radiological Sciences, Institute of Imaging Science, Vanderbilt University Medical Center
Jonas Kielmann
Localite GmbH
Cyril LAFON
INSERM LabTAU
Mikhail G Shapiro
Max Delbrück Professor of Chemical & Medical Engineering at Caltech; Investigator at HHM
Elena Andres
Dr.
Leibniz Institute for Resilience Research
Joline Fan
University of California San Francisco
Junfeng Sun
Professor
Shanghai Jiao Tong University
Maja Friedemann
PhD
University of Oxford
Hao-Li Liu
Department of Electrical Engineering, National Taiwan University
Jean-Michel Escoffre
iBraiN, U1253, Inserm, Université de Tours, France
Wynn Legon
Fralin Biomedical Research Institute at Virginia Tech Carilion
Ellen J Bubrick
Brigham and Women's Hospital, Department of Neurology, Harvard Medical School
Carys Evans
Radboud University
James Coxon
Turner Institute for Brain and Mental Health, Monash University, Melbourne, Australia
Shy Shoham
Tech4Health Institute and Departments of Neuroscience and of Ophthalmology, NYU Grossman School of Medicine
G Bruce Pike
University of Calgary
Raag D. Airan
Stanford University
Kim Butts Pauly
Stanford University
Hairong Zheng
Maxime Lafond
Laboratory of Therapeutic Applications of Ultrasound, LabTAU, Inserm U1032, Lyon, France
Johannes Algermissen
University of Zurich
Ivan Toni
Donders Institute, Radboud University
Sumner Norman
Forest Neurotech
Takahiro Osada
Department of Neurophysiology, Juntendo University School of Medicine
Charles F. Caskey
Vanderbilt University Medical Center
Arno Villringer
Max Planck Institute for Human Cognitive and Brain Sciences
Sjoerd Meijer
Donders Institute
Paul Boon
MD, PhD, FEAN
Ghent University, Belgium and Eindhoven University of Technology, The Netherlands