← Back to Search

Focused Ultrasound

Focused Ultrasound Therapy for Schizophrenia

Phase 2
Recruiting
Led By Donald Goff, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
If assigned female at birth and of childbearing potential, patients must have a negative urine pregnancy test, 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately pre-sonication at sham intervention visit, 10-minutes post-sonication at sham intervention visit (up to day 8)
Awards & highlights

Study Summary

This trial will test if a new treatment (PLIFUS) can reduce hallucinations and delusions in people with schizophrenia. 12 people will receive 1-3 sessions of PLIFUS or sham treatment. Results will show effectiveness.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects from PLIFUS could include discomfort at the stimulation site on the head, headache during or after treatment, nausea, dizziness or lightheadedness. Since this is a pilot trial assessing efficacy and safety of PLIFUS in schizophrenia patients specifically focusing on psychotic symptoms related to auditory hallucinations and delusions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been experiencing severe symptoms of psychosis for at least 4 weeks.
Select...
I am not pregnant, nursing, or planning to become pregnant and will use birth control during the study.
Select...
I have been diagnosed with schizophrenia or schizoaffective disorder.
Select...
My antipsychotic medication dose has been stable for 4 weeks, or I plan not to start any until after the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately pre-sonication at sham intervention visit, 10-minutes post-sonication at sham intervention visit (up to day 8)
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately pre-sonication at sham intervention visit, 10-minutes post-sonication at sham intervention visit (up to day 8) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Globus Pallidus interna (GPi) Functional Connectivity during PLIFUS Intervention Visit
Change in Globus Pallidus interna (GPi) Functional Connectivity during Sham Intervention Visit
Secondary outcome measures
Change in Brief Psychiatric Rating Scale (BPRS) from Baseline
Change in Psychosis Severity Rating Scale (PSRS) Score from Baseline: Auditory Hallucinations Subscale
Change in Psychosis Severity Rating Scale (PSRS) Score from Baseline: Delusions Subscale

Trial Design

2Treatment groups
Experimental Treatment
Group I: Sham, then Pulsed Low-Intensity Focused Ultrasound (PLIFUS)Experimental Treatment3 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 ShamExperimental Treatment3 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MRI
2009
Completed Phase 2
~1370

Find a Location

Who is running the clinical trial?

Max G. Schlapp Mental Hygiene Fund (New York Community Trust)UNKNOWN
Tech4HealthUNKNOWN
NYU Langone HealthLead Sponsor
1,363 Previous Clinical Trials
817,919 Total Patients Enrolled
10 Trials studying Schizophrenia
510 Patients Enrolled for Schizophrenia

Media Library

PLIFUS (Focused Ultrasound) Clinical Trial Eligibility Overview. Trial Name: NCT05643196 — Phase 2
Schizophrenia Research Study Groups: Pulsed Low-Intensity Focused Ultrasound (PLIFUS), then Sham, Sham, then Pulsed Low-Intensity Focused Ultrasound (PLIFUS)
Schizophrenia Clinical Trial 2023: PLIFUS Highlights & Side Effects. Trial Name: NCT05643196 — Phase 2
PLIFUS (Focused Ultrasound) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05643196 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research involve participants aged 75 and younger?

"This trial has a limited age range of 18 to 50. By contrast, those under the age of 18 have access to 46 different studies while people over 65 years old can join 165 trials."

Answered by AI

Does my profile qualify me to sign up for this study?

"This trial is seeking 12 individuals with schizoaffective disorder aged 18-50. The key requirements for successful enrolment are that the patient must exhibit current psychosis, established by a score of >4 on one or more BPRS items; have been diagnosed via SCID; remain stable in terms of antipsychotic medication if taking any; and for those assigned female at birth - demonstrate a negative pregnancy test result and abstain from conceiving during their participation in the study."

Answered by AI

Are patients able to apply for this research exploration?

"According to info presented on clinicaltrials.gov, this investigation is not presently accepting candidates as it was last updated December 1st 2022. Nonetheless, there are 335 other trials that require the assistance of participants at the present time."

Answered by AI

Has the FDA sanctioned Sham, then Pulsed Low-Intensity Focused Ultrasound (PLIFUS) for public use?

"The safety profile of Sham and Pulsed Low-Intensity Focused ultrasound (PLIFUS) has been graded at a 2, given that the clinical trials conducted to date have only collected evidence on its safety but not efficacy."

Answered by AI

Who else is applying?

What site did they apply to?
NYU Langone Brooklyn
What portion of applicants met pre-screening criteria?
Met criteria
~4 spots leftby Sep 2024