Evidence map›Paper›PMID 41072763›Full record

ReviewBrain stimulation

ITRUSST consensus on biophysical safety for transcranial ultrasound stimulation.

Jean-François Aubry, David Attali, Mark E Schafer, Elsa Fouragnan, Charles F Caskey, Robert Chen, Ghazaleh Darmani, Ellen J Bubrick, Jérôme Sallet, Christopher R Butler and 8 more

Registry-linked trialAbstract readConsensus StatementReview
PubMed Full text at PMC Publisher
In one paragraph

Review in Brain stimulation. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07728994 (Safety and Feasibility Study of ATTN201 Repeated Subthalamic Nucleus Focused Ultrasound Stimulation for the Treatment of Obsessive Compulsive Disorder), which is not on this map. Cited by 48 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07728994 phase2recruitingnot on this map

Safety and Feasibility Study of ATTN201 Repeated Subthalamic Nucleus Focused Ultrasound Stimulation for the Treatment of Obsessive Compulsive Disorder

TypeinterventionalSponsorUniversity of PennsylvaniaRan2026 to 2028Enrolled40ConditionsObsessive Compulsive DisorderArmsLow Intensity Focused Ultrasound, Sham (No Treatment)
3 · Its place in the literature

Who cites it

48 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors.

Jean-François AubryPhysics for Medicine Paris, Inserm U1273, ESPCI Paris, CNRS UMR8063, PSL University, Paris, France. Electronic address: jean-francois.aubry@espci.fr.
David AttaliPhysics for Medicine Paris, Inserm U1273, ESPCI Paris, CNRS UMR8063, PSL University, Paris, France; GHU-Paris Psychiatrie et Neurosciences, Hôpital Sainte Anne, Université Paris Cité, 75014, Paris, France.
Mark E SchaferRockefeller Neuroscience Institute, West Virginia University, Morgantown, WV, USA.
Elsa FouragnanBrain Research Imaging Center, 7 Derriford Rd, Plymouth PL6 8BU, UK; School of Psychology, Portland Square, Plymouth, PL4 8AA, UK.
Charles F CaskeyVanderbilt University Institute of Imaging Science, Vanderbilt University Medical School, Department of Radiology and Radiological Sciences, Nashville, TN, USA.
Robert ChenDivision of Neurology, Department of Medicine, University of Toronto, Toronto, Ontario, Canada; Krembil Research Institute, University Health Network, Toronto, Ontario, Canada.
Ghazaleh DarmaniKrembil Research Institute, University Health Network, Toronto, Ontario, Canada.
Ellen J BubrickBrigham and Women's Hospital, Harvard Medical School, Department of Neurology, 75 Francis St., Boston, MA, USA.
Jérôme SalletUniv Lyon, Université Lyon 1, Inserm, Stem Cell and Brain Research Institute U1208, Bron, France; Oxford Centre for Integrative Neuroimaging (OxCIN), Department of Experimental Psychology, University of Oxford, Oxford, OX1 3EL, UK.
Christopher R ButlerDepartment of Brain Sciences, Imperial College London, London, W12 0BZ, UK; The George Institute for Global Health, Imperial College London, London, W12 7RZ, UK.
Charlotte J StaggOxford Centre for Integrative Neuroimaging (OxCIN), FMRIB, Nuffield Department of Clinical Neurosciences, University of Oxford, FMRIB Building, John Radcliffe Hospital, Headington, Oxford, OX3, 9DU, UK; Medical Research Council Brain Network Dynamics Unit, Nuffield Department of Clinical Neurosciences, University of Oxford, Mansfield Road, Oxford, OX1 3TH, UKU, UK.
Miriam C Klein-FlüggeOxford Centre for Integrative Neuroimaging (OxCIN), Department of Experimental Psychology, University of Oxford, Oxford, OX1 3EL, UK; Department of Psychiatry, Warneford Hospital, University of Oxford, Oxford, OX3 7JX, UK.
Seung-Schik YooBrigham and Women's Hospital, Harvard Medical School, Department of Radiology, 75 Francis St., Boston, MA, USA.
Christy K HollandDivision of Cardiovascular Health and Disease, Department of Internal Medicine, University of Cincinnati, Cincinnati, OH, USA; Department of Biomedical Engineering, University of Cincinnati, Cincinnati, OH, USA.
Bradley TreebyDepartment of Medical Physics and Biomedical Engineering, University College London, London, UK; NeuroHarmonics LTD, 71-75 Shelton Street, Covent Garden, London, UK.
Eleanor MartinDepartment of Medical Physics and Biomedical Engineering, University College London, London, UK.
Lennart VerhagenDonders Institute for Brain, Cognition and Behaviour, Radboud University, 6525 GD, Nijmegen, the Netherlands. Electronic address: lennart.verhagen@donders.ru.nl.
Kim Butts PaulyStanford University, Department of Radiology, Stanford CA, 94305, USA. Electronic address: kimbutts@stanford.edu.

Funding

Neurostimulation by Ultrasound: Physical, Biophysical, and Neural MechanismsR01NS112152 · NINDS · STANFORD UNIVERSITY · PI BACCUS, STEPHEN A, BUTTS-PAULY, KIM · 2020 to 2024
$4.9M
Translating an MR-guided focused ultrasound system for first-in-human precision neuromodulation of pain circuitsUG3NS135551 · NINDS · VANDERBILT UNIVERSITY MEDICAL CENTER · PI CASKEY, CHARLES F, CHEN, LI MIN · 2023 to 2023
$4.4M
Step 1 in Designing Appropriate Shams and Controls in Human TUSR01MH131684 · NIMH · STANFORD UNIVERSITY · PI Kim Butts Pauly · 2023 to 2026
$2.6M
CRCNS: Crossbeam Transcranial Ultrasound Technology to Stimulate the Deep BrainR01EB032743 · NIBIB · STANFORD UNIVERSITY · PI BUTTS-PAULY, KIM · 2021 to 2023
$520k
NIBIB NIH HHS R01 EB032743NIMH NIH HHS R01 MH131684NINDS NIH HHS R01 NS112152NINDS NIH HHS UG3 NS135551Wellcome Trust
6 · The paper itself

Abstract

Transcranial ultrasound stimulation (TUS) is an emerging technology for non-invasive brain stimulation. The International Transcranial Ultrasonic Stimulation Safety and Standards consortium (ITRUSST) has established consensus on considerations for nonsignificant biophysical risk of TUS, drawing upon the literature and established regulations for biomedical devices. Here, we assume the application of TUS to individuals without contraindications, compromised thermoregulation, vascular vulnerabilities, or administered ultrasound contrast agents. In this context, we present a concise yet comprehensive set of levels for nonsignificant risks of TUS application. For mechanical effects, it is non-significant risk if the mechanical index (MI) or the mechanical index for transcranial application (MI

Indexed as

BrainUltrasonic TherapyHumansBiophysical effectsNeuromodulationNon-invasive brain stimulationRegulationsSafetyStandardsTranscranial ultrasound stimulation

Identifiers

PMID41072763
PMCPMC12644226

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.