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SchizophreniaPhase 2NCT05643196

Focused Ultrasound Modulation of the Globus Pallidus Interna in Schizophrenia

A Phase 2 study testing PLIFUS and MRI in people with Schizophrenia and Schizophrenia Schizoaffective, run by NYU Langone Health at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a single-site, phase 2, sham-controlled random-order cross-over pilot trial of PLIFUS targeting the right GPi in individuals with schizophrenia. Twelve individuals with schizophrenia who report continuous hallucinations or delusions of mild or greater severity will receive one session of PLIFUS and one session… Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Schizophrenia, Schizophrenia Schizoaffective
What is being tested?
PLIFUS and MRI
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
15 participants
Where
2 sitesUnited States
Study dates
6 Apr 2023to 1 Apr 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Must report current psychosis, as defined by a score of > 4 on one of the following psychosis items on the Brief Psychiatric Rating Scale (BPRS): suspiciousness, hallucinations, unusual thought content, or grandiosity continuously for at least 4 weeks.
  • Must have a diagnosis of either schizophrenia or schizoaffective disorder as established by a Structured Clinical Interview for DSM-V (SCID).
  • If taking antipsychotic medication, the dose must be unchanged for at least 4 weeks prior to randomization. If not taking antipsychotic medication, must be intending not to start medication until after completion of the study (approximately 2 weeks)-this decision must be judged to be appropriate by the research psychiatrist and by the participant's clinician.
  • If assigned female at birth and of childbearing potential, patients must
  • have a negative urine pregnancy test (all participants assigned female at birth regardless of childbearing potential will be required to submit a pregnancy test), AND;
  • not be nursing or planning a pregnancy for the duration of the study through 30 days after the last sonication visit, AND;
  • be abstinent or willing to use a reliable method of birth control from the Screening Visit and continue with the same method until termination from the study.

Who cannot join

  • Current substance abuse / dependence for substances other than nicotine and THC, (i.e. alcohol, amphetamines, barbiturates, etc.)
  • A positive urine toxicology screen (excluding THC, tricyclic antidepressants, or benzodiazepines (if prescribed).
  • Moderate or severe cannabis use disorder.
  • Diagnosis of major mood disorder or other Axis I disorder other than schizophrenia, schizoaffective disorder or schizophreniform disorder.
  • Current or recent suicidal ideation-- suicidal ideation with intent or plan (indicated by affirmative answers to items 4 or 5 of the Suicidal Ideation section of the baseline C-SSRS) in the 6 months prior to screening or subjects who represent a significant risk of suicide in the opinion of the investigator or a history of suicide attempt.
  • History of violence assessed by the Buss-Perry Aggression Questionnaire 45 and defined by violent physical contact or threat with a weapon.
Show all 18Show fewer
  • Pregnant or nursing or positive urine pregnancy test.
  • Significant medical or neurological illness by history or physical exam, including seizure disorder, history of loss of consciousness lasting more than 30 minutes related to head trauma or intellectual developmental disorder.
  • Contraindication to MRI: Metal implants, pacemaker, or other metal in the body or piercings that cannot be removed, or claustrophobia. Individuals with tattoos will be excluded from imaging if tattoos cover more than 5% of the body surface, if a tattoo is greater than 20 cm, or if a tattoo is located on the face, neck or genitals. Individuals with a contraindication to MRI may participate in the trial but will be excluded from the elective MRI component.
  • A history or brain surgery .
  • History of syncopal episode within the past 6 months.
  • A cardiac pacemaker or intra-cardiac lines.
  • An implanted neurostimulator.
  • Implanted medication infusion device.
  • Implanted metal devices or large ferromagnetic fragments in the head or upper body (excluding dental wire), or jewelry/piercing that cannot be removed.
  • Cochlear implants.
  • Skin disease at intended stimulation sites
  • The consumption of more than four alcoholic units within 24 hours before participation or any recreational drugs within 48 hours before participation.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • NYU Langone Brooklyn

    Brooklyn, New York, 11220

  • NYU Langone Health

    New York, New York, 10016

Other trials in United States

About this study

Official title: A Sham-Controlled Pilot Trial of Focused Ultrasound Modulation of the Globus Pallidus Interna in Schizophrenia

This is a single-site, phase 2, sham-controlled random-order cross-over pilot trial of PLIFUS targeting the right GPi in individuals with schizophrenia. Twelve individuals with schizophrenia who report continuous hallucinations or delusions of mild or greater severity will receive one session of PLIFUS and one session of sham PLIFUS in random order, one week apart. If no effect of PLIFUS is detected on measures of functional connectivity or psychotic symptoms in the first four completers, the trial will be changed to 3 sessions of PLIFUS or sham administered over 5 days.

Read the detailed description

The primary objectives of this study are to examine the tolerability of pulsed low-intensity focused ultrasound (PLIFUS) and its effects on brain function measured via fMRI functional connectivity and symptom response in individuals with schizophrenia. A neuronavigated single-element piezoelectric device will be utilized to noninvasively deliver transcranial PLIFUS sonication to the right globus pallidus interna, a brain region implicated in schizophrenia. The goal of this pilot study is to establish feasibility and tolerability and to determine whether the sonication procedure produces effects on the imaging biomarker and on symptoms prior to proceeding to therapeutic trials using repeated administration.

Being tested
PLIFUS, Sham PLIFUS, MRI
Medical subject headings
Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PLIFUSDevice

    Also called Sonicator-1000

    The Sonicator-1000 system will non-invasively deliver ultrasound sonications transcranially that selectively target specific areas of the brain using a neuronavigation system and the participant's MRI brain scan. The sonication parameters follow FDA and Electrotechnical Technical Commission regulation standards for diagnostic and therapeutic ultrasound.

  • Sham PLIFUSDevice

    Sham PLIFUS treatment delivers noise and patient experience that is identical to PLIFUS with Sonicator-1000 system.

  • MRIDevice

    Also called Siemens 3T Prisma

    A total of 5 MRIs will be performed using a Siemens 3T Prisma; one prior to the intervention visit, and one preceding and one immediately after each of the two sonication/sham visits.

Study groups in NCT05643196
Study groupRoleWhat they receive
Pulsed Low-Intensity Focused Ultrasound (PLIFUS), then ShamExperimentalParticipants will receive PLIFUS sonication on the first intervention visit, then sham sonication on the second intervention visit. Visits will be separated by 1 week. Sonication at both visits will be preceded and followed by fMRI and an exit medical examination. Sonication will be delivered in a pulse pattern over 10 minutes.
Receives: Device: PLIFUS; Device: Sham PLIFUS; Device: MRI
Sham, then Pulsed Low-Intensity Focused Ultrasound (PLIFUS)ExperimentalParticipants will receive sham sonication on the first intervention visit, then PLIFUS sonication on the second intervention visit. Visits will be separated by 1 week. Sonication at both visits will be preceded and followed by fMRI and an exit medical examination. Sonication will be delivered in a pulse pattern over 10 minutes.
Receives: Device: PLIFUS; Device: Sham PLIFUS; Device: MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Globus Pallidus Interna (GPi) Functional Connectivity During PLIFUS Intervention Visit

    Change in GPi functional connectivity measured via functional MRI (fMRI) captured pre-sonication and 10 minutes post-sonication during the PLIFUS intervention visit.

    Measured: Immediately pre-sonication and 10 minutes post-sonication at Intervention Visit 1 (Day 0) and Intervention Visit 2 (Day 7)

Secondary outcomes (2)

  1. Change in Auditory Hallucinations Rating Scale (AHRS) Score From Baseline

    A 7-item scale developed to measure specific characteristics of auditory hallucinations (frequency, reality, loudness, number of voices, length, attentional salience, distress level). Each item is rated on a separate Likert scale. The total score, ranging from 0 to 44, indicates the overall severity of the hallucinations, with higher scores suggesting more severe symptoms.

    Measured: Baseline, Final Study Visit (Day 14-16)

  2. Change in Delusions Experience Sampling Assessment (DESA) Score From Baseline

    A 4-item scale (conviction, distress, preoccupation, disruption) used to assess moment-to-moment experience and detect more rapid changes of delusions. Participants are asked to rate the same delusional belief at the moment on a 7-point Likert scale (1 (not at all) to 7 (very much)). The total score is the sum of responses ranging from 1-28; higher scores indicate more severe symptoms.

    Measured: Baseline, Final Study Visit (Day 14-16)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2022
  2. Study start6 Apr 2023
  3. Primary completion25 Mar 2024
  4. Study completion1 Apr 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05643196
Sponsor's protocol ID
22-00997
Status last verified
May 2025
First submitted
21 Nov 2022
Last updated
30 May 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: \[donald.goff@nyulangone.org\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Publications

  • Qi W, Gilad A, Santacatterina M, Brinker S, Capichioni G, Ando F, Shoham S, Goff DC. Transcranial ultrasound stimulation of the right globus pallidus interna in schizophrenia: A randomized, sham-controlled pilot study. NPJ Acoust. 2026;2(1):39. doi: 10.1038/s44384-026-00076-3. Epub 2026 Oct 20.

    PubMed 42908713

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PLIFUS and MRI in people with Schizophrenia and Schizophrenia Schizoaffective, run by NYU Langone Health at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Globus Pallidus Interna (GPi) Functional Connectivity During PLIFUS Intervention Visit (time frame: Immediately pre-sonication and 10 minutes post-sonication at Intervention Visit 1 (Day 0) and Intervention Visit 2 (Day 7)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05643196, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.

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