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
Kai Yu
Department of Biomedical Engineering, University of Connecticut
Muhammad Zubair
Openwater
Gianmarco Pinton
Joint Department of Biomedical Engineering, University of North Carolina at Chapel Hill & North, Carolina State University
Martin Wimmers
TU/e EM4C&C; Donders Dnstitute for Brain Cognition and Behaviour Radboud University
James Choi
Imperial College London
Andrew Bishay
Semel Institute for Neuroscience and Human Behavior Department of Psychiatry & Biobehavioral Sciences University of California, Los Angeles
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
Mark Palmeri
M.D, Ph.D
Duke University, Department of Biomedical Engineering
Arno Villringer
Max Planck Institute for Human Cognitive and Brain Sciences
Harriet Lea-Banks
University College London
Robin O. Cleveland
Institute of Biomedical Engineering, University of Oxford
Sjoerd Meijer
Donders Institute
Maximilian Lueckel
M.Sc.
Leibniz Institute for Resilience Research (LIR) & Neuroimaging Center (NIC), Johannes Gutenberg University Medical Center, Mainz, Germany
James McLaughlan
Dr
University of Leeds
Gregory A. Fonzo, Ph.D.
Assistant Professor
The University of Texas at Austin Dell Medical School
James Hong
Academic Clinical Fellow in psychiatry
Department of Psychiatry, University of Oxford
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
Samuel Pichardo
Radiology and Clinical Neurosciences, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary
Ellen J Bubrick
Brigham and Women's Hospital, Department of Neurology, Harvard Medical School
Andres Lozano
Division of Neurosurgery, University Health Network and University of Toronto
Hartwig Roman Siebner
Danish Research Centre for Magnetic Resonance, Department of Radiology and Nuclear Medicine, Copenhagen University Hospital; Amager and Hvidovre
José A Pineda-Pardo
HM CINAC MADRID (Centro Integral de Neurociencias Abarca Campal); Hospital Universitario HM Puerta del Sur, HM Hospitales. Madrid, Spain
W Apoutou N'Djin
Laboratory of Therapeutic Applications of Ultrasound (LabTAU), INSERM, University Claude Bernard of Lyon, France
Julian Kosciessa
Postdoctoral Research Fellow
Donders Institute for Brain, Cognition, and Behaviour
Oleg A Sapozhnikov
University of Washington, USA and Moscow State University, Russia
Lisa Spiering
University of Oxford
Tulika Nandi
Vrije Universiteit Amsterdam
Kevin A Caulfield
Department of Psychiatry, Medical University of South Carolina
Bin He
Department of Biomedical Engineering, Carnegie Mellon University
Pavlos Anastasiadis
Assistant Professor
University of Maryland
Jean-Francois Aubry
Institute Physics for Medicine Paris – INSERM, CNRS, ESPCI Paris-PSL, Paris, France
Jérôme Sallet JS
INSERM - University of Oxford
Johannes Algermissen
University of Zurich
Carys Evans
Radboud University
Yoshikazu Ugawa
Fukushima Medical University
Christopher Petkov
University of Iowa
Vivek Sharma
Donders Institute for Brain, Cognition, and Behaviour, Radboud University.
Tom Matula
Director, Center for Industrial and Medical Ultrasound
Unhiversity of Washington
J Brian Fowlkes
PhD
Department of Radiology and Department of Biomedical Engineering, University of Michigan
G Bruce Pike
University of Calgary
Sebastian Reichstein
MSc
Donders Institute Nijmegen, the Netherlands
Bradley E. Treeby
NeuroHarmonics LTD, 71-75 Shelton Street, Covent Garden, London, UK
Maxime Lafond
Laboratory of Therapeutic Applications of Ultrasound, LabTAU, Inserm U1032, Lyon, France
Elisa Konofagou
Columbia University
Ayache Bouakaz
Inserm iBraiN
Lennart Verhagen
Donders Institute for Brain, Cognition and Behaviour, Radboud University, 6525 GD, Nijmegen, the Netherlands
Matthew Rushworth
University of Oxford
Vera A Khokhlova
University of Washington, USA and Moscow State University, Russia, D.Sc
Dennis L Parker
Department of Radiology and Imaging Science, University of Utahs
Adam Harouak
Dr. med. univ.
Medical university of Vienna
Eva Feredoes
Dr
University of Reading
Yasuo Terao
Department of Medical Physiology, Kyorin University
Mikhail G Shapiro
Max Delbrück Professor of Chemical & Medical Engineering at Caltech; Investigator at HHM
Ivan Suarez-Castellano
PhD
Laboratory of Therapeutic Applications of Ultrasound (LabTAU), INSERM U1032, Lyon, France.
Arno Schmitgen
Localite GmbH
Marwan Engels
Donders Institute
Seung-Schik Yoo
Associate Professor, Department of Radiology, Brigham and Women's Hospital, Harvard Medical School
Ying Meng
University of Toronto
Charles F. Caskey
Vanderbilt University Medical Center
Robert S Fisher
MD, PhD
Department of Neurology and Neurological Science, Stanford University School of Medicine
Jean-Michel Escoffre
iBraiN, U1253, Inserm, Université de Tours, France
Elena Andres
Dr.
Leibniz Institute for Resilience Research
Alexander Bystritsky
CEO
Brainsonix
Taylor Webb
Department of Radiology and Imaging Sciences, University of Utah
Eleanor Martin
Department of Medical Physics and Biomedical Engineering, University College London, London
Estelle Raffin
Dr
CNRS, LPNC
Takahiro Osada
Department of Neurophysiology, Juntendo University School of Medicine
Joshua Marquez
Mr
King's College London
Axel Thielscher
Technical Unversity of Denmark & Danish Research Centre for MR
Keith R. Murphy
Attune Neurosciences, San Francisco, CA, U.S.A.
Kim Butts Pauly
Stanford University
Joseph Balfe
University of Oxford
James Coxon
Turner Institute for Brain and Mental Health, Monash University, Melbourne, Australia
Tommaso Di Ianni
PhD
University of California San Francisco
Ruggero Condorelli
Research Assistant
Donders Centre for Cognition
Ryan T Ash
MD, PhD
Department of Psychiatry and Behavioral Sciences, University of California San Francisco
Sophie Morse
Dr
Imperial College London
Fady Girgis
University of Calgary
Jonas Kielmann
Localite GmbH
Marco K Wittmann
University College London
Daniel Whitcomb
University of Bristol
Lilian Aline Weber
Center for Cognitive Science, Osnabrueck University, Osnabrueck, Germany
Davide Martino
Department of Clinical Neuroscience & Hotchkiss Brain Institute, University of Calgary, Calgary, AB Canada
Hairong Zheng
Lei SUN
The Hong Kong Polytechnic University
Mary R Lee
MD
Veterans Affairs Medical Center, Washington DC
Marcus Kaiser
Centre for Neurotechnology, Neuromodulation, and Neurotherapeutics, University of Nottingham and DeepBrain, United Kingdom
Jan Kubanek
Psychiatry, Radiology, Neurology, and Biomedical Engineering; Washington University
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
Benjamin Kop
Stanford University
Hao-Li Liu
Department of Electrical Engineering, National Taiwan University
Norman Spivak
UCLA
Wayne Kreider
University of Washington, USA
Raag D. Airan
Stanford University
Erno Hermans
Donders Institute for Brain, Cognition and Behaviour
Rajiv Mahadevan
Attune Neurosciences
Paul Boon
MD, PhD, FEAN
Ghent University, Belgium and Eindhoven University of Technology, The Netherlands
Seiki Konishi
Department of Neurophysiology, Juntendo University School of Medicine
Elsa F. Fouragnan
School of Psychology, Faculty of Health, University of Plymouth, UK; Brain Research Imaging Center, Faculty of Health, University of Plymouth, UK