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Focused Ultrasound

Focused Ultrasound Neuromodulation for Schizophrenia

N/A
Waitlist Available
Led By Alon Mogliner, MD, PhD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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 has decision-making capacity to provide informed consent, as determined by an independent psychiatrist
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to month 3
Awards & highlights

Study Summary

This trial will use MRI-guided LIFU to target and modulate the activity of neurons in the thalamus of people with treatment-resistant schizophrenia in an effort to improve symptoms.

Who is the study for?
This trial is for adults over 21 with treatment-resistant schizophrenia, characterized by persistent auditory hallucinations or delusions despite trying three different antipsychotic medications. Participants must be able to walk and women must use contraception or not be of childbearing potential.Check my eligibility
What is being tested?
The study tests a non-invasive technique called MRI-guided low-intensity focused ultrasound (LIFU) on the thalamus to see if it can help people with schizophrenia who haven't improved after standard treatments.See study design
What are the potential side effects?
Potential side effects may include discomfort at the site of ultrasound application, headache, nausea, or other unspecified effects related to brain stimulation techniques.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have moderate symptoms of disorganization, hallucinations, or unusual thoughts.
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I am mentally capable of making my own health decisions, as confirmed by a psychiatrist.
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I am 21 years old or older.
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I can walk on my own without help.
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I have been diagnosed with schizophrenia by a psychiatrist and confirmed with the SCID-5.
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My hallucinations or delusions have not improved despite trying three different antipsychotic medications over the past year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to month 3
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to month 3 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Patients who Complete All Visits Related to the Study
Secondary outcome measures
Change in Brief Psychiatric Rating Scale (BPRS) Score from Baseline
Change in Montreal Cognitive Assessment (MoCA) Score from Baseline
Syndrome

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment-resistant Schizophrenia groupExperimental Treatment1 Intervention
The subject will present for three baseline visits, followed by a treatment visit and subsequently follow-up visits at 24-hours, 48-hours, 1 week, 2 weeks, 1 month, and 3 months. Feasibility will be assessed as well as symptoms via detailed symptom rating scales at each visit. At the treatment visit itself, participants will undergo MR-guided low-intensity focused ultrasound of the MD thalamus.

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,367 Previous Clinical Trials
839,718 Total Patients Enrolled
10 Trials studying Schizophrenia
522 Patients Enrolled for Schizophrenia
Alon Mogliner, MD, PhDPrincipal InvestigatorNYU Langone Health

Media Library

Insightec Exablate Neuro MR-guided focused ultrasound transducer (Focused Ultrasound) Clinical Trial Eligibility Overview. Trial Name: NCT05259306 — N/A
Schizophrenia Research Study Groups: Treatment-resistant Schizophrenia group
Schizophrenia Clinical Trial 2023: Insightec Exablate Neuro MR-guided focused ultrasound transducer Highlights & Side Effects. Trial Name: NCT05259306 — N/A
Insightec Exablate Neuro MR-guided focused ultrasound transducer (Focused Ultrasound) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05259306 — N/A

Frequently Asked Questions

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

Does this research venture encompass elderly individuals above the age of seventy?

"Individuals between 21 and 80 years old may sign up for this clinical trial."

Answered by AI

What are the goals of this experiment?

"This study, which has a 3-month duration, investigates the viability of Low-intensity focused ultrasound (LIFU) to treat refractory schizophrenia. It will measure secondary endpoints such as changes in severity of symptoms assessed via Brief Psychiatric Rating Scale (BPRS), Positive and Negative Syndrome Scale (PANSS), and BPRS scores from baseline. The PANSS is scored on a 7 point scale with absent symptoms = 1 point; while rating under BPRS ranges between 18 - 126 points higher values indicating more severe conditions."

Answered by AI

Who can be accepted into this scientific experiment?

"Recruitment is currently underway for this clinical trial, which seeks 3 patients suffering from treatment-resistant schizophrenia in the age range of 21 to 80. To qualify candidates must meet a rigorous set of criteria including possession of medical records indicating an approved diagnosis, having undergone two distinct antipsychotic treatments within the past five years equivalent to 500mg/day or more chlorpromazine, display moderate symptoms on at least two BPRS positive symptom tests during three baseline visits and exhibit ambulatory capacity. Furthermore all female participants are expected to use accepted contraceptive methods with negative pregnancy results certified through urine samples across each assessment period while confirming they possess decisional autonomy"

Answered by AI

Are there any open enrolment options for this clinical experiment currently?

"Clinicaltrials.gov currently indicates that this experiment is not recruiting, as the last update was made on October 3rd 2022 and it was originally published June 1st 2023. However, there are 334 other clinical trials actively seeking participants right now."

Answered by AI

Who else is applying?

What site did they apply to?
NYU Langone Health
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Low-Intensity Focused Ultrasound Neuromodulation of the Mediodorsal Thalamus for Treatment-Resistant Schizophrenia
2024. "Low-Intensity Focused Ultrasound Neuromodulation of the Mediodorsal Thalamus for Treatment-Resistant Schizophrenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05259306.
~2 spots leftby Jun 2025
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