Focused Ultrasound Therapy for Schizophrenia

Recruiting at 1 trial location

Overseen By Donald Goff, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: NYU Langone Health

Must be taking: Antipsychotics

Disqualifiers: Substance abuse, Mood disorder, Suicidal ideation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests PLIFUS, a sound wave technique, on people with schizophrenia who have ongoing hallucinations or delusions. The goal is to see if targeting a specific brain area can improve their symptoms.

Will I have to stop taking my current medications?

If you are taking antipsychotic medication, you must keep the dose the same for at least 4 weeks before starting the trial. If you are not on antipsychotic medication, you should not start any until the study is over, which is about 2 weeks.

How is the treatment PLIFUS different from other treatments for schizophrenia?

PLIFUS (Low-Intensity Focused Ultrasound) is unique because it uses sound waves to target specific brain areas, potentially offering a non-invasive way to influence brain circuits involved in schizophrenia, unlike traditional medications that often have systemic effects. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Focused Ultrasound Therapy for Schizophrenia?

Research on similar treatments like repetitive Transcranial Magnetic Stimulation (rTMS) guided by MRI has shown promise in treating auditory hallucinations in schizophrenia, suggesting that imaging-guided therapies can be effective. However, the specific effectiveness of Focused Ultrasound Therapy for schizophrenia is not directly supported by the provided studies. ^{6 7 8 9 10}

Who Is on the Research Team?

Donald Goff, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for individuals with schizophrenia or schizoaffective disorder who have been experiencing continuous mild or greater hallucinations or delusions for at least 4 weeks. Participants must be stable on their current antipsychotic medication dose, if any, for the past month, and females of childbearing potential must use reliable birth control. People with significant medical conditions, metal implants incompatible with MRI, substance abuse issues (excluding nicotine and THC), major mood disorders other than schizophrenia spectrum disorders, recent suicidal ideation or attempts are excluded.

Inclusion Criteria

I have been experiencing severe symptoms of psychosis for at least 4 weeks.

I am not pregnant, nursing, or planning to become pregnant and will use birth control during the study.

I have been diagnosed with schizophrenia or schizoaffective disorder.

Exclusion Criteria

You have been diagnosed with a mood disorder or other mental health condition, except for schizophrenia, schizoaffective disorder, or schizophreniform disorder.

History of violence assessed by the Buss-Perry Aggression Questionnaire 45 and defined by violent physical contact or threat with a weapon.

Pregnant or nursing or positive urine pregnancy test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one session of PLIFUS and one session of sham PLIFUS in random order, one week apart

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for changes in functional connectivity and psychotic symptoms

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• MRI
• PLIFUS
• Sham PLIFUS

Trial Overview The study tests PLIFUS (Pulsed Low-Intensity Focused Ultrasound) targeting the right Globus Pallidus Interna in people with schizophrenia to see if it affects psychotic symptoms and brain function. Each participant will undergo one session of real PLIFUS and a sham (fake) treatment in random order a week apart. If early results show no benefit after four participants complete the sessions, the protocol may change to three sessions over five days.

How Is the Trial Designed?

Group I: Sham, then Pulsed Low-Intensity Focused Ultrasound (PLIFUS) Experimental Treatment 3 Interventions

Participants 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.

Group II: Pulsed Low-Intensity Focused Ultrasound (PLIFUS), then Sham Experimental Treatment 3 Interventions

Participants 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.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Max G. Schlapp Mental Hygiene Fund (New York Community Trust)

Collaborator

Trials

1

Recruited

20+

Tech4Health

Collaborator

Trials

1

Recruited

20+

The New York Community Trust

Collaborator

Trials

7

Recruited

1,200+

Doris Duke Charitable Foundation

Collaborator

Trials

65

Recruited

264,000+

Published Research Related to This Trial

A randomized-controlled trial involving 144 patients with schizophrenia will test the efficacy of high-frequency transcranial random noise stimulation (hf-tRNS) to alleviate persistent symptoms, with the primary outcome being a 25% reduction in symptoms after 10 sessions.

The study aims to explore not only the clinical effects of hf-tRNS on symptoms like auditory hallucinations but also its impact on brain activity and cognitive functions, potentially establishing it as a new treatment option for patients resistant to traditional antipsychotics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining transcranial random noise stimulation as an add-on treatment for persistent symptoms in schizophrenia (STIM'Zo): a study protocol for a multicentre, double-blind, randomized sham-controlled clinical trial. Brunelin, J., Mondino, M., Haesebaert, J., et al.[2022]

Bimodal repetitive transcranial magnetic stimulation (rTMS) significantly reduced symptoms of schizophrenia in 10 patients who were unresponsive to medication, with improvements noted in all subscales of the Positive and Negative Syndrome Scale (PANSS) by Day 29.

The treatment also showed potential benefits for short-term auditory verbal memory, as indicated by significant increases in neurocognitive test scores after the rTMS sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjunctive treatment of bimodal repetitive transcranial magnetic stimulation (rTMS) in pharmacologically non-responsive patients with schizophrenia: a preliminary study. Oh, SY., Kim, YK.[2011]

In a study involving 16 patients with schizophrenia, high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) over the left dorsolateral prefrontal cortex did not show significant effects on negative symptoms compared to sham treatment.

While there was a trend for improvement in some symptoms with sham rTMS, the study concluded that HF-rTMS is not effective for treating negative symptoms of schizophrenia, suggesting the need for exploring alternative rTMS methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The double-blind sham-controlled study of high-frequency rTMS (20 Hz) for negative symptoms in schizophrenia: negative results. Novák, T., Horácek, J., Mohr, P., et al.[2006]

Citations

1. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[The dynamics of the cerebral circulation during the treatment of schizophrenics with a depressive syndrome by means of the intravenous laser irradiation of the blood]. [2016]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Two-day treatment of auditory hallucinations by high frequency rTMS guided by cerebral imaging: a 6 month follow-up pilot study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Examining transcranial random noise stimulation as an add-on treatment for persistent symptoms in schizophrenia (STIM'Zo): a study protocol for a multicentre, double-blind, randomized sham-controlled clinical trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Adjunctive treatment of bimodal repetitive transcranial magnetic stimulation (rTMS) in pharmacologically non-responsive patients with schizophrenia: a preliminary study. [2011]

5. Sweden pubmed.ncbi.nlm.nih.gov

The double-blind sham-controlled study of high-frequency rTMS (20 Hz) for negative symptoms in schizophrenia: negative results. [2006]

6. England pubmed.ncbi.nlm.nih.gov

Neuroplasticity of neocortical circuits in schizophrenia. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Cranial MR imaging of sequelae of prefrontal lobotomy. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Modafinil modulates anterior cingulate function in chronic schizophrenia. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Effect of low-level laser therapy (LLLT) on cognitive impairment among patients with chronic schizophrenia: a double-blind randomized placebo-controlled clinical trial. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Comparison of haloperidol, risperidone, sertindole, and modafinil to reverse an attentional set-shifting impairment following subchronic PCP administration in the rat--a back translational study. [2021]