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LIFU Effects & Outcomes: Mechanisms Evaluating Striatal Systems Imaging (LEO MESSI)

Study acronym: MESSI-LEO
StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoints added 0 → 2 primary endpoints
See other at-risk trials from University of California, San Francisco

Record History

  1. Study title expanded, about 2 wordsv3 See this version in full on ClinicalTrials.gov ↗
  2. Primary endpoint(s) modified Phase changed: not specified → not applicable · Sponsor changed: [Redacted] to University of California, San Francisco · Trial status changed: Withheld → Not Yet Recruiting · 6 morev2 Show 9 more changesShow less
    • Phase changed: not specified → not applicable
    • Sponsor changed: [Redacted] to University of California, San Francisco
    • Trial status changed: Withheld → Not Yet Recruiting
    • Enrollment changed: None → 12
    • Trial arms changed: 0 → 2
    • Primary and study completion dates: Dec 1, 2027
    • Start date: Feb 1, 2027
    • Collaborators expanded, about 3 words
    • Study title shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07710989
Lead Sponsor University of California, San Francisco
Collaborators: Attune Neurosciences Inc
Conditions Schizophrenia, Auditory Hallucinations
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov