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A Wearable, Steerable, Transcranial Low-Intensity Focused Ultrasound System.

Christopher R Bawiec¹, Peter J Hollender¹, Sarah B Ornellas¹

¹Openwater, San Francisco, California, USA.

Journal of Ultrasound in Medicine : Official Journal of the American Institute of Ultrasound in Medicine

|October 25, 2024

Summary

This study introduces a novel transcranial low-intensity focused ultrasound (LIFU) system for brain neuromodulation. The system safely and effectively targeted the anterior medial prefrontal cortex in healthy volunteers.

Keywords:

low‐intensity focused ultrasound (LIFU)neuromodulation therapeutic ultrasound transcranial focused ultrasound (tFUS)

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Area of Science:

Neuroscience
Biomedical Engineering
Medical Technology

Background:

Transcranial low-intensity focused ultrasound (LIFU) offers precise neuromodulation for brain targets.
Potential applications exist for psychiatric and neurological disorders.

Purpose of the Study:

Present a novel ultrasound system for forehead-based anterior brain neuromodulation.
Evaluate the safety and usability of this LIFU system in human volunteers.

Main Methods:

Developed and described a LIFU system with neuronavigation and planning.
Validated system capabilities via simulations and water experiments.
Assessed safety and usability in 20 healthy volunteers targeting the amPFC.

Main Results:

System demonstrated a safe steering range of 1.8x2.5x2 cm at 5 cm depth.
No adverse effects or imaging-detected damage were observed in volunteers.
The system successfully targeted the amPFC in all participants, with good tolerance.

Conclusions:

The presented LIFU system safely delivered transcranial ultrasound to the amPFC.
The technology is well-tolerated and suitable for exploring clinical neuromodulation efficacy.