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

160 Signees

Lisa Spiering

University of Oxford

Ayache Bouakaz

Inserm iBraiN

Johannes Algermissen

University of Zurich

Eleanor Stride

University of Oxford

Pierre Pouget

ICM Paris Brain Institute, CNRS

Daniel Whitcomb

University of Bristol

Jérôme Sallet JS

INSERM - University of Oxford

Charlotte Reese Marshall

Assistant Professor

University of Birmingham

Junfeng Sun

Professor

Shanghai Jiao Tong University

Vera A Khokhlova

University of Washington, USA and Moscow State University, Russia, D.Sc

Sebastian Reichstein

MSc

Donders Institute 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

Arno Villringer

Max Planck Institute for Human Cognitive and Brain Sciences

Marcus Kaiser

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

Kevin A Caulfield

Department of Psychiatry, Medical University of South Carolina

Bradley E. Treeby

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

Kenneth van der Zee

PhD Candidate

Donders Institute for Brain, Cognition, and Behaviour

Joshua Marquez

Mr

King's College London

Tommaso Di Ianni

PhD

University of California San Francisco

Estelle Raffin

Dr

CNRS, LPNC

Sumner Norman

Forest Neurotech

Samuel Pichardo

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

Cyril LAFON

INSERM LabTAU

Raag D. Airan

Stanford University

Dennis L Parker

Department of Radiology and Imaging Science, University of Utahs

Mikhail G Shapiro

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

Maja Friedemann

PhD

University of Oxford

Robert Chen

Krembil Research Institute and University of Toronto

Paul Boon

MD, PhD, FEAN

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

Joseph Balfe

University of Oxford

Eleanor Martin

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

Rajiv Mahadevan

Attune Neurosciences

Axel Thielscher

Technical Unversity of Denmark & Danish Research Centre for MR

Kai Yu

Department of Biomedical Engineering, University of Connecticut

Ruggero Condorelli

Research Assistant

Donders Centre for Cognition

Jan Kubanek

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

Andres Lozano

Division of Neurosurgery, University Health Network and University of Toronto

Martin Wimmers

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

Christopher Petkov

University of Iowa

Matthew Rushworth

University of Oxford

James McLaughlan

Dr

University of Leeds

David Norris

Radboud University, Donders Institute for Brain Cognition and Behaviour

Wayne Kreider

University of Washington, USA

Tulika Nandi

Vrije Universiteit Amsterdam

Elena Andres

Dr.

Leibniz Institute for Resilience Research

Emilie Franceschini

Aix-Marseille University, CNRS, LMA, Marseille

Fady Girgis

University of Calgary

Ghazaleh Darmani

Krembil Research Institute, University of Toronto

Benjamin Kop

Stanford University

Norman Spivak

UCLA

Marco K Wittmann

University College London

Elsa F. Fouragnan

School of Psychology, Faculty of Health, University of Plymouth, UK; Brain Research Imaging Center, Faculty of Health, University of Plymouth, UK

Thomas Paul

PhD Student

Ecole Polytechnique F�d�rale de Lausanne

Keith R. Murphy

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

Ivan Suarez-Castellano

PhD

Laboratory of Therapeutic Applications of Ultrasound (LabTAU), INSERM U1032, Lyon, France.

Til Ole Bergmann

Prof. Dr.

Johannes Gutenberg University Medical Center Mainz, Germany

Nader Saffari

University College London (UCL)

Maxime Lafond

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

Adam C Waspe

Hospital for Sick Children and University of Toronto

Davide Martino

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

Jean-Michel Escoffre

iBraiN, U1253, Inserm, Université de Tours, France

David J Segar

Nudge

Ying Meng

University of Toronto

Karin Roelofs

Donders Institute, Centre for Cognitive Neuroimaging, Radboud University Nijmegen, The Netherlands

Gianmarco Pinton

Joint Department of Biomedical Engineering, University of North Carolina at Chapel Hill & North, Carolina State University

Li Min Chen

MD, PhD

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

G Bruce Pike

University of Calgary

Wynn Legon

Fralin Biomedical Research Institute at Virginia Tech Carilion

Cyril Atkinson-Clement

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

Alexander Bystritsky

CEO

Brainsonix

Francesco Prada

Istituto Neurologico C. Besta, Milano

Ellen J Bubrick

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

Ivan Toni

Donders Institute, Radboud University

Leo P Sugrue

MD, PhD

University of California, San Francisco

Mark Palmeri

M.D, Ph.D

Duke University, Department of Biomedical Engineering

James Choi

Imperial College London

Oleg A Sapozhnikov

University of Washington, USA and Moscow State University, Russia

Joline Fan

University of California San Francisco

Robert S Fisher

MD, PhD

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

Lilian Aline Weber

Center for Cognitive Science, Osnabrueck University, Osnabrueck, Germany

James Hong

Academic Clinical Fellow in psychiatry

Department of Psychiatry, University of Oxford

Niklas Kroner-Weigl

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

Tom Matula

Director, Center for Industrial and Medical Ultrasound

Unhiversity of Washington

Hanneke den Ouden

Professor

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

Harriet Lea-Banks

University College London

J Brian Fowlkes

PhD

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

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

William J Tyler

UAB Center for Neuroengineering and Brain Computer Interfaces

Hairong Zheng

Lennart Verhagen

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

Lei SUN

The Hong Kong Polytechnic University

Antonios Pouliopoulos

King's College London

Arno Schmitgen

Localite GmbH

James Coxon

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

Kim Butts Pauly

Stanford University

Seung-Schik Yoo

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

Merritt Maduke

Stanford University School of Medicine

Chris Butler

Department of Brain Sciences, Imperial College London

Muhammad Zubair

Openwater

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