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

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • LIFU — DEVICE
    MRI-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 LIFU
    Active LIFU targeting teh caudate
  • Placebo Comparator: Sham Sonication
    Sham Unfocused Sonication

Primary Outcome Measure

Auditory Hallucinations [ Time Frame: Baseline and Post-Treatment (Weekly follow-up for 8 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94158-

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