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

Yunzhe Liu

Beijing Normal University

Matthew Rushworth

University of Oxford

Adam Harouak

Dr. med. univ.

Medical university of Vienna

Yaoheng Yang

University of Southern California

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

Ivan Suarez-Castellano

PhD

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

Tatiana D. Khokhlova

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

Li Min Chen

MD, PhD

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

Cyril LAFON

INSERM LabTAU

Brooke Staveland

Postdoctoral Fellow

University of California, San Francisco

Camilla Nord

University of Cambridge, MRC Cognition and Brain Sciences Unit

Joshua Marquez

Mr

King's College London

Eleanor Martin

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

Lei SUN

The Hong Kong Polytechnic University

Axel Thielscher

Technical Unversity of Denmark & Danish Research Centre for MR

David Norris

Radboud University, Donders Institute for Brain Cognition and Behaviour

Soren Konecky

CTO

Openwater

Samuel Pichardo

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

Sumner Norman

Forest Neurotech

Dennis L Parker

Department of Radiology and Imaging Science, University of Utahs

Julian Kosciessa

Postdoctoral Research Fellow

Donders Institute for Brain, Cognition, and Behaviour

Carys Evans

Radboud University

Andres Lozano

Division of Neurosurgery, University Health Network and University of Toronto

Arno Schmitgen

Localite GmbH

Ryan M. Jones

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

Nima Khalighinejad

University of Oxford

Merritt Maduke

Stanford University School of Medicine

Leo P Sugrue

MD, PhD

University of California, San Francisco

James Choi

Imperial College London

Thomas Paul

PhD Student

Ecole Polytechnique F�d�rale de Lausanne

Antonios Pouliopoulos

King's College London

Robert S Fisher

MD, PhD

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

Cyril Atkinson-Clement

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

Junfeng Sun

Professor

Shanghai Jiao Tong University

Seiki Konishi

Department of Neurophysiology, Juntendo University School of Medicine

Elena Andres

Dr.

Leibniz Institute for Resilience Research

Robert Chen

Krembil Research Institute and University of Toronto

Wynn Legon

Fralin Biomedical Research Institute at Virginia Tech Carilion

Sjoerd Meijer

Donders Institute

Raag D. Airan

Stanford University

Adam C Waspe

Hospital for Sick Children and University of Toronto

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

Mark Schafer

Rockefeller Neuroscience Institute, West Virginia University

Ayache Bouakaz

Inserm iBraiN

Muhammad Zubair

Openwater

Ying Meng

University of Toronto

Ellen J Bubrick

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

Wayne Kreider

University of Washington, USA

Alexander Bystritsky

CEO

Brainsonix

Robin O. Cleveland

Institute of Biomedical Engineering, University of Oxford

Arno Villringer

Max Planck Institute for Human Cognitive and Brain Sciences

Martin Wimmers

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

Lennart Verhagen

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

J Brian Fowlkes

PhD

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

Emilie Franceschini

Aix-Marseille University, CNRS, LMA, Marseille

Pierre Pouget

ICM Paris Brain Institute, CNRS

Maxime Lafond

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

Jean-Michel Escoffre

iBraiN, U1253, Inserm, Université de Tours, France

Chris Butler

Department of Brain Sciences, Imperial College London

Hanneke den Ouden

Professor

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

Kim Butts Pauly

Stanford University

Lawrence A Crum

University of Washington

Charles F. Caskey

Vanderbilt University Medical Center

Eva Feredoes

Dr

University of Reading

James McLaughlan

Dr

University of Leeds

Ruggero Condorelli

Research Assistant

Donders Centre for Cognition

Kai Yu

Department of Biomedical Engineering, University of Connecticut

James Hong

Academic Clinical Fellow in psychiatry

Department of Psychiatry, University of Oxford

Charlotte Reese Marshall

Assistant Professor

University of Birmingham

Shy Shoham

Tech4Health Institute and Departments of Neuroscience and of Ophthalmology, NYU Grossman School of Medicine

Keith R. Murphy

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

James Coxon

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

Eleanor Stride

University of Oxford

Erno Hermans

Donders Institute for Brain, Cognition and Behaviour

Seung-Schik Yoo

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

William J Tyler

UAB Center for Neuroengineering and Brain Computer Interfaces

Elsa F. Fouragnan

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

Joseph Balfe

University of Oxford

Jonas Kielmann

Localite GmbH

Vincent P Ferrera

Zuckerman Institute for Mind Brain and Behavior, Columbia University

Kenneth Bader

University of Chicago

Hairong Zheng

Maximilian Lueckel

M.Sc.

Leibniz Institute for Resilience Research (LIR) & Neuroimaging Center (NIC), Johannes Gutenberg University Medical Center, Mainz, Germany

Sebastian Reichstein

MSc

Donders Institute Nijmegen, the Netherlands

Gregory A. Fonzo, Ph.D.

Assistant Professor

The University of Texas at Austin Dell Medical School

Ryan T Ash

MD, PhD

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

Karin Roelofs

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

Suhas Vijayakumar

Neuroimaging Center, Johannes Gutenberg University Medical Center, Mainz

Hao-Li Liu

Department of Electrical Engineering, National Taiwan University

G Bruce Pike

University of Calgary

Joline Fan

University of California San Francisco

Vivek Sharma

Donders Institute for Brain, Cognition, and Behaviour, Radboud University.

Marcus Kaiser

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

José A Pineda-Pardo

HM CINAC MADRID (Centro Integral de Neurociencias Abarca Campal); Hospital Universitario HM Puerta del Sur, HM Hospitales. Madrid, Spain

Ghazaleh Darmani

Krembil Research Institute, University of Toronto

Jeremy Barenholtz

Nudge

Christopher Petkov

University of Iowa

Takahiro Osada

Department of Neurophysiology, Juntendo University School of Medicine

Marco K Wittmann

University College London

Christopher R Bawiec

Prophetic