ITRUSST consensus on biophysical safety for transcranial ultrasound stimulation by Jean-François Aubry instant download

ITRUSST consensus on biophysical safety for transcranial ultrasound stimulation by Jean-François Aubry instant download

ABSTRACTKeywords:Transcranial ultrasound stimulation (TUS) is an emerging technology for non-invasive brain stimulation. The NeuromodulationInternational Transcranial Ultrasonic Stimulation Safety and Standards consortium (ITRUSST) has established Non-invasive brain stimulationconsensus on considerations for nonsignificant biophysical risk of TUS, drawing upon the literature and estabTranscranial ultrasound stimulationlished regulations for biomedical devices. Here, we assume the application of TUS to individuals without conBiophysical effectstraindications, compromised thermoregulation, vascular vulnerabilities, or administered ultrasound contrast Safetyagents. In this context, we present a concise yet comprehensive set of levels for nonsignificant risks of TUS Standardsapplication. For mechanical effects, it is non-significant risk if the mechanical index (MI) or the mechanical index Regulationsfor transcranial application (MItc) does not exceed 1.9. For thermal effects, it is non-significant risk if any of the following three levels are met: the peak temperature rise does not exceed 2 ◦C or the peak absolute temperature does not exceed 39 ◦C, assuming a baseline temperature of 37 ◦C, the thermal dose does not exceed 2 CEM43 in brain tissue, 16 CEM43 in bone tissue, and 21 CEM43 in skin tissue, or specific values of the thermal index (TI) * Corresponding author.E-mail addresses: [email protected] (J.-F. Aubry), [email protected] (L. Verhagen), [email protected] (K. Butts Pauly). 1 These authors contributed equally. 6 May 2025; Received in revised form 6 October 2025; Accepted 6 October 2025 Available online 8 October 20251935-861X/© 2025 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license ( Aubry et al. Brain Stimulation 18 (2025) 1896–1905for a given exposure time. This report reflects a consensus expert opinion and can i