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

ConditionsSchizophreniaAuditory Hallucinations
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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

12 Participants
are divided into 2 treatment groups
Group A: Active LIFUActive comparator 1 intervention
Group B: Sham SonicationPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Auditory Hallucinations

We will compare hallucinations after LIFU to caudate with baseline and the sham unfocused sonication condition using the Visual Analog Scale (VAS) and Auditory Vocal Hallucination Rating Scales (AVHRS).

Time frame
Baseline and Post-Treatment (Weekly follow-up for 8 weeks)
2

Caudate-superior temporal cortical (STC) connectivity

We will compare functional connectivity using Fisher r-to-z values from the CONN toolbox between the caudate and STC after LIFU compared to baseline and the sham unfocused sonication condition

Time frame
Baseline and Post-Treatment ( Day 5)

Secondary outcomes

1

Clinical Positive and Negative Symptoms

We will compare positive and negative symptoms using the Positive and Negative Syndrome Scale (PANSS) after LIFU targeting the caudate with baseline and the sham unfocused sonication condition.

Time frame
Baseline and Post-Treatment (Weekly follow-up for 8 weeks)

Other outcomes

Sponsors and contacts

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University of California, San Francisco

Lead sponsor

Attune Neurosciences Inc

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: