Mechanisms Evaluating Striatal Systems Imaging: LIFU Effects & Outcomes
Part of paid clinical trials in San Francisco, California.
- Sponsor
- University of California, San Francisco
- Study ID
- NCT07710989
- Status
- Not Yet Recruiting
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Conditions
- Auditory Hallucinations
- Schizophrenia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 64 Years
- Healthy Volunteers
- Not accepted
Interventions
- LIFU — DEVICEMRI-guided, neuronavigated low-intensity focused ultrasound (LIFU) delivered to the caudate target will be compared to sham unfocused sonication delivered using the same device and procedures as the active intervention but without focal ultrasound energy to the target.
Study Details
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 Dates
- First listed
- Jul 17, 2026
- Start date
- Feb 1, 2027
- Status verified
- Jul 2026
- Primary completion
- Dec 1, 2027
- Completion
- Dec 1, 2027
Study Design
- Enrollment
- 12 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Active LIFUActive LIFU targeting teh caudate
- Placebo Comparator: Sham SonicationSham Unfocused Sonication
Primary Outcome Measure
Auditory Hallucinations [ Time Frame: Baseline and Post-Treatment (Weekly follow-up for 8 weeks) ]
Central Contacts
- Karuna Subramaniam, PhD415-476-6888
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94158 | - |
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