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Sound waves aimed at brain may quiet schizophrenia symptoms

NCT ID NCT05259306

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This pilot study tests whether low-intensity focused ultrasound, guided by MRI, can safely and feasibly target a deep brain region (the thalamus) in people with treatment-resistant schizophrenia. Only 3 participants were planned, and the study is currently suspended. The goal is to see if the procedure is practical and to measure any changes in symptoms like hallucinations.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MRI-guided low-intensity focused ultrasound (LIFU) device
What this could lead to
If it works, this could point toward a new way to ease symptoms of treatment-resistant schizophrenia without surgery or medication.
What could go wrong
This is a very early pilot study with only 3 participants and is currently suspended. It tests feasibility, not effectiveness, so results may not lead to a treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 3 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2027

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subject has an age greater or equal to 21 years old. * Subject has a diagnosis of schizophrenia as determined by a review of medical records, discussion with referring psychiatrist, as well as the Structured Clinical Interview for DSM-5 (SCID-5). * Subject is determined to be treatment-resistant for at least one year prior to Visit 1 as demonstrated by clinical evidence (determined via medical records and referring psychiatrist) of persistent auditory hallucinations and/or delusions that have not responded to treatment with three adequate trials/regimens of antipsychotic medication, as follows: a. Adequate trials of any two different antipsychotic medications, belonging to different classes of at least 12 weeks equivalent to at least 500 mg/day of chlorpromazine within the previous five years. * Subject has a score of at least moderate (4) on two of the three BPRS positive symptoms (conceptual disorganization, hallucinatory behavior, and unusual thought content) at all three Baseline Visits. * Subject must be ambulatory. * Female subjects must be practicing an acceptable method of contraception, postmenopausal, physically incapable of childbearing, or; if practicing an acceptable method of contraception, a negative urine pregnancy test must be confirmed at all three Baseline Visits * Subject has decision-making capacity to provide informed consent, as determined by an independent psychiatrist. Exclusion Criteria: * Subject has a positive urine toxicology screen at any of the three Baseline Visits. * Subject has medical contraindications to the procedure as determined by an internist or primary care physician. * Subject is pregnant or breast-feeding. * Subject has a history of alcohol or substance abuse within the past 6 months. * Subject has a medical illness, comorbid psychiatric illness, and/or abnormal diagnostic finding that would interfere with the completion of the study, confound the results of the study, or pose risk to the patient. * Subject has participated in another investigational drug trial or therapeutic trial within 30 days of Baseline Visit 1. * Subject has a neurologic condition or history of traumatic brain injury associated with loss of consciousness and/or intracranial bleeding. * Subject is considered high suicide risk as screened by the Columbia-Suicide Severity Rating Scale (C-SSRS). * Subject has a defibrillator, pacemaker, or other implants that would interfere with MRI * Subject has significant social factors that greatly interfere with consistent follow up and/or support.

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Conditions

The condition(s) this trial relates to.

Schizophrenia, Treatment-Resistant treatment-refractory schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • NYU Langone Health

    New York, New York, 10016, United States

More trials for these conditions

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