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Auditory hallucinations—or hearing voices that others do not hear—affect more than 70% of people with schizophrenia. Despite treatment with antipsychotic medications, approximately 40% continue to experience persistent hallucinations. For these patients, new treatment approaches are urgently needed.

The research team at the University of California San Francisco (UCSF), led by Karuna Subramaniam, Ph.D., a professor of psychiatry, has launched a first-in-human Phase I clinical trial to evaluate the safety and feasibility of repeated low-intensity focused ultrasound (LIFU) sessions targeting the caudate, a deep brain region within the striatum that may play a role in hallucinations. The team is using a noninvasive wearable device developed by Attune Neurosciences.

Enrollment is underway to investigate whether repeated treatments can produce sustained reductions in hallucinations. The trial builds on encouraging preliminary findings published in Brain Stimulation, which demonstrated that a single session of LIFU produced significant, albeit temporary, reductions in hallucinations.

The study plans to enroll up to 12 participants. Each participant will receive five daily sessions of active LIFU targeting the caudate and five sessions of a sham control (unfocused sonication), with a washout period between conditions.

The unfocused control condition delivers the same amount of ultrasound energy and is designed to preserve the sensory experience of treatment, but without focusing ultrasound energy on a specific brain target. Comparing the two conditions will help researchers evaluate whether active LIFU reduces hallucination symptoms beyond any placebo or other nonspecific treatment effects.

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