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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

None

Trial design

Treatments tested in this trial

  • LIFU

Treatment groups

12 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of California, San Francisco

Lead sponsor

Attune Neurosciences Inc

Collaborator