Low-Intensity Focused Ultrasound of the Amygdala in Depression and Anxiety: A First-in-Human Active-Controlled Trial

The study examined the safety and efficacy of low-intensity focused ultrasound (FUS) targeting the amygdala in ten patients with major depressive disorder. Participants underwent a randomized trial comparing ultrasound directed at the right amygdala with control ultrasound applied to the primary somatosensory cortex. No serious adverse events occurred during the procedure, although adverse events were more frequent after amygdala ultrasound. Imaging examinations (fMRI and ASL) confirmed specific modulation of the targeted amygdala region and its connections with the hippocampus and prefrontal cortex. Patients reported spontaneous feelings of calmness and clarity following amygdala ultrasound, but not after control ultrasound. The results suggest that FUS is a safe and effective method for modulating deep brain structures with potential for further development in treating psychiatric disorders.