Open Letter

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.

I want to sign

145 Signees

Yasuo Terao

Department of Medical Physiology, Kyorin University

Tulika Nandi

Vrije Universiteit Amsterdam

Kevin A Caulfield

Department of Psychiatry, Medical University of South Carolina

Ellen J Bubrick

Brigham and Women's Hospital, Department of Neurology, Harvard Medical School

Seung-Schik Yoo

Associate Professor, Department of Radiology, Brigham and Women's Hospital, Harvard Medical School

Ryan M. Jones

Physical Sciences Platform, Sunnybrook Research Institute, Toronto, ON, Canada

Ivan Toni

Donders Institute, Radboud University

Joline Fan

University of California San Francisco

Elisa Konofagou

Columbia University

Davide Martino

Department of Clinical Neuroscience & Hotchkiss Brain Institute, University of Calgary, Calgary, AB Canada

Christopher R Bawiec

Prophetic

Oleg A Sapozhnikov

University of Washington, USA and Moscow State University, Russia

Emilie Franceschini

Aix-Marseille University, CNRS, LMA, Marseille

Julia Sophia Crone

University of Vienna; Paris Lodron University of Salzburg

Mikhail G Shapiro

Max Delbrück Professor of Chemical & Medical Engineering at Caltech; Investigator at HHM

Yaoheng Yang

University of Southern California

G Bruce Pike

University of Calgary

Sumner Norman

Forest Neurotech

Til Ole Bergmann

Neuroimaging Center (NIC), Johannes Gutenberg University Medical Center Mainz, Langenbeckstr. 1, 55131 Mainz, Germany

Tommaso Di Ianni

PhD

University of California San Francisco

Sebastian Reichstein

MSc

Donders Institute Nijmegen, the Netherlands

Wayne Kreider

University of Washington, USA

Jérôme Sallet JS

INSERM - University of Oxford

Ryan T Ash

MD, PhD

Department of Psychiatry and Behavioral Sciences, University of California San Francisco

J Brian Fowlkes

PhD

Department of Radiology and Department of Biomedical Engineering, University of Michigan

Christopher Petkov

University of Iowa

Bradley E. Treeby

NeuroHarmonics LTD, 71-75 Shelton Street, Covent Garden, London, UK

W Apoutou N'Djin

Laboratory of Therapeutic Applications of Ultrasound (LabTAU), INSERM, University Claude Bernard of Lyon, France

Jean-Michel Escoffre

iBraiN, U1253, Inserm, Université de Tours, France

Lisa Spiering

University of Oxford

Ghazaleh Darmani

Krembil Research Institute, University of Toronto

Nima Khalighinejad

University of Oxford

Julian Kosciessa

Postdoctoral Research Fellow

Donders Institute for Brain, Cognition, and Behaviour

Eleanor Martin

Department of Medical Physics and Biomedical Engineering, University College London, London

Niklas Kroner-Weigl

Max Planck Institute for Human Cognitive and Brain Sciences, Leipzig, Germany

Antonios Pouliopoulos

King's College London

Ayache Bouakaz

Inserm iBraiN

Benjamin Kop

Stanford University

Pierre Pouget

ICM Paris Brain Institute, CNRS

Robin O. Cleveland

Institute of Biomedical Engineering, University of Oxford

Eleanor Stride

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

Lennart Verhagen

Donders Institute for Brain, Cognition and Behaviour, Radboud University, 6525 GD, Nijmegen, the Netherlands

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

Jan Kubanek

Psychiatry, Radiology, Neurology, and Biomedical Engineering; Washington University

Rajiv Mahadevan

Attune Neurosciences

Paul Boon

MD, PhD, FEAN

Ghent University, Belgium and Eindhoven University of Technology, The Netherlands

William J Tyler

UAB Center for Neuroengineering and Brain Computer Interfaces

Elena Andres

Dr.

Leibniz Institute for Resilience Research

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

Mark Palmeri

M.D, Ph.D

Duke University, Department of Biomedical Engineering

Marcus Kaiser

Centre for Neurotechnology, Neuromodulation, and Neurotherapeutics, University of Nottingham and DeepBrain, United Kingdom

Marco K Wittmann

University College London

Leo P Sugrue

MD, PhD

University of California, San Francisco

Nader Saffari

University College London (UCL)

Yunzhe Liu

Beijing Normal University

Samuel Pichardo

Radiology and Clinical Neurosciences, Hotchkiss Brain Institute, Cumming School of Medicine, University of Calgary

Kai Yu

Department of Biomedical Engineering, University of Connecticut

Taylor Webb

Department of Radiology and Imaging Sciences, University of Utah

Til Ole Bergmann

Prof. Dr.

Johannes Gutenberg University Medical Center Mainz, Germany

Mary R Lee

MD

Veterans Affairs Medical Center, Washington DC

Erik Dumont

CEO, Image Guided Therapy, France

Trevor Chong

Monash University

Matthew Rushworth

University of Oxford

Sjoerd Meijer

Donders Institute

Jean-Francois Aubry

Institute Physics for Medicine Paris – INSERM, CNRS, ESPCI Paris-PSL, Paris, France

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

Maja Friedemann

PhD

University of Oxford

Li Min Chen

MD, PhD

Department of Radiology and Radiological Sciences, Institute of Imaging Science, Vanderbilt University Medical Center

Kim Butts Pauly

Stanford University

Carys Evans

Radboud University

Daniel Whitcomb

University of Bristol

Robert S Fisher

MD, PhD

Department of Neurology and Neurological Science, Stanford University School of Medicine

Hartwig Roman Siebner

Danish Research Centre for Magnetic Resonance, Department of Radiology and Nuclear Medicine, Copenhagen University Hospital; Amager and Hvidovre

Keith R. Murphy

Attune Neurosciences, San Francisco, CA, U.S.A.

Ying Meng

University of Toronto

Raag D. Airan

Stanford University

Nadège Bault

University of Plymouth, UK

Cyril Atkinson-Clement

Brain Research and Imaging Centre, Faculty of Health, University of Plymouth, Plymouth PL6 8BU, United Kingdom.

Maxime Lafond

Laboratory of Therapeutic Applications of Ultrasound, LabTAU, Inserm U1032, Lyon, France

Nathan McDannold

Kenneth Bader

University of Chicago

Bin He

Department of Biomedical Engineering, Carnegie Mellon University

James Coxon

Turner Institute for Brain and Mental Health, Monash University, Melbourne, Australia

Mark Schafer

Rockefeller Neuroscience Institute, West Virginia University

Martin Wimmers

TU/e EM4C&C; Donders Dnstitute for Brain Cognition and Behaviour Radboud University

Andres Lozano

Division of Neurosurgery, University Health Network and University of Toronto

Erno Hermans

Donders Institute for Brain, Cognition and Behaviour

Estelle Raffin

Dr

CNRS, LPNC

Hao-Li Liu

Department of Electrical Engineering, National Taiwan University

Sophie Morse

Dr

Imperial College London

Johannes Algermissen

University of Zurich

Francesco Prada

Istituto Neurologico C. Besta, Milano

Chris Butler

Department of Brain Sciences, Imperial College London

Kenneth van der Zee

PhD Candidate

Donders Institute for Brain, Cognition, and Behaviour

Ruggero Condorelli

Research Assistant

Donders Centre for Cognition

Tatiana D. Khokhlova

Division of Gastroenterology, University of Washington School of Medicine Applied Physics Laboratory, University of Washington

Merritt Maduke

Stanford University School of Medicine

Cyril LAFON

INSERM LabTAU

Brooke Staveland

Postdoctoral Fellow

University of California, San Francisco