This study evaluated amygdala-focused low-intensity transcranial focused ultrasound neuromodulation delivered using the BrainSonix BX Pulsar 1002, representing one of the most rigorous psychiatric ultrasound trials conducted to date. The investigators employed a hybrid design that included a double-blind, sham-controlled phase to establish target engagement, followed by an unblinded single-arm phase to explore feasibility and clinical signal.
By targeting the amygdala—a central node in fear and affective circuitry—the study addressed a longstanding limitation in noninvasive psychiatric neuromodulation. The sham-controlled phase demonstrated measurable biological engagement beyond placebo, while the follow-on phase explored translational relevance. Together, the trial design and system-level reproducibility enabled by the BX Pulsar 1002 helped define a scalable, FDA-relevant pathway for ultrasound-based interventions in depression.
