Low-Intensity Focused Ultrasound Neuromodulation of the Mediodorsal Thalamus for Treatment-Resistant Schizophrenia

NCT05259306 | Suspended DMC FDA Device

• 1 other identifier: 21-01291
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study aims to investigate the use of MRI-guided low-intensity focused ultrasound (LIFU) to modulate neuronal activity within the thalamus in human subjects with treatment-resistant schizophrenia.

Conditions

Treatment-resistant Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Number of Patients who Complete All Visits Related to the Study

  Measurement of feasibility of low-intensity focused ultrasound (LIFU) for treatment-resistant schizophrenia. Feasibility defined as two out of three patients completing all visits related to the study.

  Up to Month 3

Secondary Outcomes (3)

• Change in Brief Psychiatric Rating Scale (BPRS) Score from Baseline

  Baseline, Month 3

• Change in Positive and Negative Syndrome Scale (PANSS) Score from Baseline

  Baseline, Month 3

• Change in Montreal Cognitive Assessment (MoCA) Score from Baseline

  Baseline, Month 3

Study Arms (1)

Treatment-resistant Schizophrenia group

EXPERIMENTAL

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.

Device: Insightec Exablate Neuro MR-guided focused ultrasound transducer

Interventions

Insightec Exablate Neuro MR-guided focused ultrasound transducer DEVICE

This study will be utilizing the Insightec Exablate Neuro MR-guided focused ultrasound transducer to deliver low-intensity ultrasonic energy precisely and safely to the target region of the brain. MRgFUS has been FDA approved at high-intensity to treat essential tremor and Parkinson's disease associated tremor. Device premarket approval number (PMA) is P150038, and FDA approval notice was July 11, 2016. This study will be using this device not to make any lesions in the brain (as it is currently FDA approved), but instead to use the precision and non-invasive nature of the device to target the MD thalamus region of the brain at intensities currently approved by the FDA for transcranial ultrasound.

Treatment-resistant Schizophrenia group

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Schizophrenia, Treatment-Resistant

Condition Hierarchy (Ancestors)

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Alon Mogliner, MD, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: February 28, 2022
• Study Start (Estimated): June 1, 2027
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data.Requests should be directed to alon.mogilner@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)