LIFU Effects & Outcomes: Mechanisms Evaluating Striatal Systems Imaging (LEO MESSI)
Starting soon · Not applicable · Has a placebo group
Conditions studied: Schizophrenia, Auditory Hallucinations
In brief
Individuals with schizophrenia often experience persistent auditory hallucinations despite treatment with antipsychotic medications. Research suggests that abnormal communication between the striatum and the auditory cortex contributes to hallucinations. This first-in-human, proof-of-concept Phase 1 study will evaluate the safety, feasibility, and preliminary effects of repeated-session low-intensity focused ultrasound (LIFU), a non-invasive neuromodulation technique targeting the striatum. The study will examine whether LIFU can safely modulate brain circuits involved in hallucinations, reduce abnormal communication between the striatum and auditory cortex, and improve auditory hallucination symptoms.
Key facts
- Study ID
- NCT07710989
- Run by
- University of California, San Francisco
- People needed
- 12
- Starts
- 2027-02-01
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-08-05
Who can join
Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18-64 years of age, inclusive of all gender identities
- Current DSM-5 diagnosis of schizophrenia
- Persistent clinically-significant auditory hallucinations
- No contraindications for MRI, confirmed via standard safety screening procedures
- No neurological disorder
- Clinically stable (outpatient past 12 weeks; same dose medications in 4 weeks)
- Females will be tested for pregnancy and pregnant women will be excluded.
You may not qualify if…
- Clinically significant neurological disorder or MRI incompatibility
Where it is running
- University of California, San Francisco — San Francisco, California, United States
Full record on ClinicalTrials.gov
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