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ITRUSST Consensus on Biophysical Safety for Transcranial Ultrasound Stimulation.

Jean-François Aubry1, David Attali1,2, Mark E Schafer3

  • 1Physics for Medicine Paris, Inserm U1273, ESPCI Paris, CNRS UMR8063, PSL University, Paris, France.

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|November 24, 2025
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Summary

The International Transcranial Ultrasonic Stimulation Safety and Standards consortium (ITRUSST) defined nonsignificant risk levels for transcranial ultrasound stimulation (TUS). These guidelines address mechanical and thermal effects for safe, non-invasive brain stimulation applications.

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Area of Science:

  • Neuroscience
  • Biomedical Engineering
  • Medical Physics

Background:

  • Transcranial ultrasound stimulation (TUS) is an emerging non-invasive brain stimulation technology.
  • Establishing safety standards is crucial for the clinical translation of TUS.
  • The International Transcranial Ultrasonic Stimulation Safety and Standards consortium (ITRUSST) convened to address TUS safety.

Purpose of the Study:

  • To establish consensus on nonsignificant biophysical risk levels for TUS.
  • To provide clear guidelines for the safe application of TUS in individuals without contraindications.
  • To inform regulatory bodies and ethical evaluations regarding TUS safety.

Main Methods:

  • Reviewing existing literature on TUS biophysics and safety.
  • Leveraging established regulations for biomedical devices.
  • Defining specific thresholds for mechanical and thermal effects to denote nonsignificant risk.

Main Results:

  • Nonsignificant mechanical risk is defined as a mechanical index (MI) or MItc not exceeding 1.9.
  • Nonsignificant thermal risk is met if peak temperature rise is ≤2°C, peak absolute temperature is ≤39°C, or specific thermal dose (CEM43) or thermal index (TI) values are not exceeded.
  • These levels apply to individuals without specific contraindications, thermoregulation issues, vascular vulnerabilities, or contrast agents.

Conclusions:

  • The consensus provides practical levels for nonsignificant risk in TUS applications.
  • These guidelines can inform, but do not replace, official regulatory standards and ethical reviews.
  • Further research is needed to establish definitive thresholds for significant risk in TUS.