The University of California San Francisco has launched enrollment for a Phase 1 clinical trial led by Dr. Karuna Subramaniam to test a noninvasive, wearable focused ultrasound headband on schizophrenia patients. Developed by Attune Neurosciences, the ATTN201 headband targets hyperactive striatal-temporal brain circuits 65 millimeters deep to reduce medication-resistant auditory hallucinations, which affect up to 40 percent of patients. Initial pilot testing demonstrated immediate symptom reductions exceeding 50 percent.
UCSF MESSI-LEO clinical trial
- ▪The UCSF opened enrollment for a Phase 1 clinical trial testing low-intensity focused ultrasound to treat auditory hallucinations in schizophrenia
- ▪The MESSI-LEO trial led by Dr. Karuna Subramaniam will enroll up to 12 participants between ages 18 and 64 for five daily active ultrasound sessions targeting the caudate paired with five sham sessions.
- ▪The MESSI-LEO trial at the University of California San Francisco is funded by the Focused Ultrasound Foundation under grant 1685505.
Attune Neurosciences headband technology
- ▪The ATTN201 wearable headband built by Attune Neurosciences uses 128 transducer elements operating at 500 kilohertz to steer acoustic energy 65 millimeters deep to the caudate head.
- ▪Attune Neurosciences utilizes ultrashort-echo-time MRI sequences to capture skull geometry and create individualized acoustic delay models for targeting without ionizing radiation.
Ultrasound treatment outcomes and symptom relief
- ▪In a 2026 published pilot study of three patients, a single session of active low-intensity focused ultrasound produced over 50 percent reductions in hallucination severity and frequency.
- ▪Participants in the active UCSF ultrasound trial reported immediate symptom relief, describing voices growing quiet or shifting to the distant background following repeated treatment sessions.
Brain mechanisms Underlying auditory hallucinations
- ▪A 2023 University of California San Francisco fMRI study published in Schizophrenia Research found that reduced functional connectivity between the anterior caudate head and thalamus predicted hallucination severity in schizophrenia.
- ▪Hyperactivity and elevated dopamine release in the nucleus accumbens and caudate head create abnormal functional connectivity with the superior temporal cortex, disrupting brain sensory gating during auditory hallucinations.
Limitations of current schizophrenia treatments
- ▪Auditory hallucinations affect over 70 percent of people with schizophrenia, and current dopamine-blocking antipsychotic medications fail to silence voices in up to 40 percent of patients.
- ▪Clozapine produces only a partial therapeutic response in 40 to 70 percent of medication-resistant schizophrenia patients while carrying side effect risks including agranulocytosis, metabolic complications, and sedation.
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