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ITRUSST Consensus on Biophysical Safety for Transcranial Ultrasonic Stimulation
arXiv.org
09 Nov 2023
Abstract
Transcranial ultrasonic stimulation (TUS) is an emerging technology for
non-invasive brain stimulation. Currently, there are no established guidelines
for the safe application of ultrasonic neuromodulation in humans beyond those
used for diagnostic ultrasound. Therefore, in a series of meetings, the
International Consortium for Transcranial Ultrasonic Stimulation Safety and
Standards (ITRUSST) has established expert consensus on considerations for the
biophysical safety of TUS.
As with diagnostic ultrasound, there are two main biophysical risks
associated with the application of TUS: mechanical and thermal bioeffects.
Mechanical bioeffects mainly concern the risk of acoustic cavitation, which can
lead to local tissue damage such as cell death or blood vessel hemorrhage.
Thermal bioeffects may occur when mechanical energy is converted into thermal
energy through absorption, leading to tissue heating and potential thermal
damage.
The ITRUSST safety group has established recommendations based on existing
guidelines for diagnostic ultrasound from regulatory bodies such as the Food
and Drug Administration (FDA), the British Medical Ultrasound Society (BMUS)
and the American Institute of Ultrasound in Medicine (AIUM). Here, we review
existing regulatory guidelines for biomedical ultrasound and consider their
relevance for TUS. We then present a concise but comprehensive set of
parameters and levels that we consider to be biophysically safe, as summarized
in Table 1. While the limit of safety may be higher than these stated levels,
the purpose of this paper is to state that this group considers these levels to
be safe for transcranial ultrasound stimulation.
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Details
- Title
- ITRUSST Consensus on Biophysical Safety for Transcranial Ultrasonic Stimulation
- Creators
- Jean-Francois AubryDavid AttaliMark SchaferElsa FouragnanCharles CaskeyRobert ChenGhazaleh DarmaniEllen J BubrickJérôme SalletChristopher ButlerCharlotte StaggMiriam Klein-FlüggeSeung-Schik YooBrad TreebyLennart VerhagenKim Butts Pauly
- Publication Details
- arXiv.org
- Resource Type
- Preprint
- Language
- English
- Academic Unit
- School of Biomedical Engineering, Science, and Health Systems
- Other Identifier
- 991021811640004721