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

Bradley E. Treeby

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

Camilla Nord

University of Cambridge, MRC Cognition and Brain Sciences Unit

Harriet Lea-Banks

University College London

Muhammad Zubair

Openwater

Jean-Michel Escoffre

iBraiN, U1253, Inserm, Université de Tours, France

Kai Yu

Department of Biomedical Engineering, University of Connecticut

Tulika Nandi

Vrije Universiteit Amsterdam

Junfeng Sun

Professor

Shanghai Jiao Tong University

James Hong

Academic Clinical Fellow in psychiatry

Department of Psychiatry, University of Oxford

Vincent P Ferrera

Zuckerman Institute for Mind Brain and Behavior, Columbia University

Nader Saffari

University College London (UCL)

David Norris

Radboud University, Donders Institute for Brain Cognition and Behaviour

Davide Martino

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

Johannes Algermissen

University of Zurich

Francesco Prada

Istituto Neurologico C. Besta, Milano

Lilian Aline Weber

Center for Cognitive Science, Osnabrueck University, Osnabrueck, Germany

Karin Roelofs

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

Marco K Wittmann

University College London

Vera A Khokhlova

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

Gianmarco Pinton

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

Marcus Kaiser

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

Norman Spivak

UCLA

Ying Meng

University of Toronto

Yasuo Terao

Department of Medical Physiology, Kyorin University

Rajiv Mahadevan

Attune Neurosciences

Pavlos Anastasiadis

Assistant Professor

University of Maryland

Charles F. Caskey

Vanderbilt University Medical Center

Daisy Thompson-Lake

Assistant Professor

University of Virginia

Maximilian Lueckel

M.Sc.

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

Elsa F. Fouragnan

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

Trevor Chong

Monash University

Jean-Francois Aubry

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

Mikhail G Shapiro

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

Mary R Lee

MD

Veterans Affairs Medical Center, Washington DC

Kenneth van der Zee

PhD Candidate

Donders Institute for Brain, Cognition, and Behaviour

Nadège Bault

University of Plymouth, UK

W Apoutou N'Djin

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

Marwan Engels

Donders Institute

Ivan Toni

Donders Institute, Radboud University

Niklas Kroner-Weigl

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

Lawrence A Crum

University of Washington

G Bruce Pike

University of Calgary

Charlotte Reese Marshall

Assistant Professor

University of Birmingham

Oleg A Sapozhnikov

University of Washington, USA and Moscow State University, Russia

Sophie Morse

Dr

Imperial College London

Bin He

Department of Biomedical Engineering, Carnegie Mellon University

Nima Khalighinejad

University of Oxford

Seiki Konishi

Department of Neurophysiology, Juntendo University School of Medicine

Tommaso Di Ianni

PhD

University of California San Francisco

Alexander Bystritsky

CEO

Brainsonix

Li Min Chen

MD, PhD

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

Joseph Balfe

University of Oxford

Cyril Atkinson-Clement

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

Leo P Sugrue

MD, PhD

University of California, San Francisco

James Coxon

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

Axel Thielscher

Technical Unversity of Denmark & Danish Research Centre for MR

Arno Schmitgen

Localite GmbH

Eleanor Stride

University of Oxford

Jan Kubanek

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

Seung-Schik Yoo

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

Ayache Bouakaz

Inserm iBraiN

Estelle Raffin

Dr

CNRS, LPNC

Robin O. Cleveland

Institute of Biomedical Engineering, University of Oxford

Hairong Zheng

William J Tyler

UAB Center for Neuroengineering and Brain Computer Interfaces

David J Segar

Nudge

Andrew Bishay

Semel Institute for Neuroscience and Human Behavior Department of Psychiatry & Biobehavioral Sciences University of California, Los Angeles

Daniel Whitcomb

University of Bristol

Raag D. Airan

Stanford University

Taylor Webb

Department of Radiology and Imaging Sciences, University of Utah

Sumner Norman

Forest Neurotech

Eva Feredoes

Dr

University of Reading

Maxime Lafond

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

Til Ole Bergmann

Prof. Dr.

Johannes Gutenberg University Medical Center Mainz, Germany

Arno Villringer

Max Planck Institute for Human Cognitive and Brain Sciences

Yunzhe Liu

Beijing Normal University

Samuel Pichardo

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

Eleanor Martin

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

Joshua Marquez

Mr

King's College London

Kenneth Bader

University of Chicago

Hanneke den Ouden

Professor

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

Julia Sophia Crone

University of Vienna; Paris Lodron University of Salzburg

Christopher Petkov

University of Iowa

James McLaughlan

Dr

University of Leeds

Ruggero Condorelli

Research Assistant

Donders Centre for Cognition

José A Pineda-Pardo

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

Hao-Li Liu

Department of Electrical Engineering, National Taiwan University

Adam C Waspe

Hospital for Sick Children and University of Toronto

Elena Andres

Dr.

Leibniz Institute for Resilience Research

Dennis L Parker

Department of Radiology and Imaging Science, University of Utahs

Tatiana D. Khokhlova

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

Nathan McDannold

Lei SUN

The Hong Kong Polytechnic University

Fady Girgis

University of Calgary

Hartwig Roman Siebner

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

James Choi

Imperial College London

Joline Fan

University of California San Francisco

Benjamin Kop

Stanford University

Jonas Kielmann

Localite GmbH

Pierre Pouget

ICM Paris Brain Institute, CNRS