Safety of Clinical Ultrasound Neuromodulation

Sonja Radjenovic, Gregor Dörl, Martin Gaal, Roland Beisteiner, Sonja Radjenovic, Gregor Dörl, Martin Gaal, Roland Beisteiner

Abstract

Transcranial ultrasound holds much potential as a safe, non-invasive modality for navigated neuromodulation, with low-intensity focused ultrasound (FUS) and transcranial pulse stimulation (TPS) representing the two main modalities. While neuroscientific and preclinical applications have received much interest, clinical applications are still relatively scarce. For safety considerations, the current literature is largely based on guidelines for ultrasound imaging that uses various physical parameters to describe the ultrasound pulse form and expected bioeffects. However, the safety situation for neuromodulation is inherently different. This article provides an overview of relevant ultrasound parameters with a focus on bioeffects relevant for safe clinical applications. Further, a retrospective analysis of safety data for clinical TPS applications in patients is presented.

Keywords: FUS; TPS; clinical neuromodulation; neuromodulation; transcranial ultrasound.

Conflict of interest statement

R.B. receives research grants from STORZ Medical (including equipment) and is President of the Organization for Human Brain Mapping Alpine Chapter and the Austrian Society for fMRI (unpaid). S.R., G.D. and M.G. are involved in TPS research and application projects.

Figures

Figure 1
Figure 1
Experienced pressure and pain were rated during TPS treatment. (A) Percentages over all sessions and (B) number of patients across all sessions.
Figure 2
Figure 2
Adverse events during (A,B) and after (C,D). TPS treatment reported by patients across all sessions and percentage over all sessions, respectively. Detailed numbers are in Table 2.

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