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

Mechanisms of Low-intensity Focused Ultrasound Targeting Striatal Circuits Underlying Auditory Hallucinations in Schizophrenia

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 64 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Ultrasound, MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "Study Objective: This first-in-human, early Phase 1 investigator-initiated clinical trial will evaluate the safety, feasibility, tolerability, target engagement, and preliminary mechanistic effects of repeated-session low-intensity focused ultrasound (LIFU) targeting the caudate, a key striatal region implicated in auditory hallucinations in schizophrenia."
  • "Study Design: Participants with schizophrenia and persistent clinically significant auditory hallucinations will undergo MRI-guided, neuronavigated LIFU targeting an individualized caudate target, a key striatal region implicated in hallucination-related corticostriatal circuitry."
  • "Individualized MRI-guided targeting and subject-specific acoustic simulations will optimize focal targeting while maintaining acoustic exposure within established safety limits."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This early study tests low-intensity focused ultrasound, which uses sound waves to target a brain area without surgery. It is for adults with schizophrenia who keep hearing voices or sounds that are not there despite medicine. Researchers will test whether repeated sessions are safe, change brain signals, and ease these symptoms.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 to 64, of any gender identity.
  • Have a current diagnosis of schizophrenia.
  • Keep hearing voices or sounds that are not there, with symptoms serious enough to need care.
  • Can safely have an MRI brain scan, as checked by a safety screening.
  • Have no disorder of the brain or nerves.
  • Have been stable in outpatient care for the past 12 weeks and on the same medicine doses for 4 weeks.
  • Female participants must take a pregnancy test and must not be pregnant.

Who can't join

  • Have a significant disorder of the brain or nerves.
  • Cannot safely have an MRI scan.
  • Are pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. 18-64 years of age, inclusive of all gender identities 2. Current DSM-5 diagnosis of schizophrenia 3. Persistent clinically-significant auditory hallucinations 4. No contraindications for MRI, confirmed via standard safety screening procedures 5. No neurological disorder 6. Clinically stable (outpatient past 12 weeks; same dose medications in 4 weeks) 7. Females will be tested for pregnancy and pregnant women will be excluded. Exclusion Criteria: Clinically significant neurological disorder or MRI incompatibility

Study sites (1)

CA