Status:
SUSPENDED
Low-Intensity Focused Ultrasound Neuromodulation of the Mediodorsal Thalamus for Treatment-Resistant Schizophrenia
Lead Sponsor:
NYU Langone Health
Conditions:
Treatment-resistant Schizophrenia
Eligibility:
All Genders
21-80 years
Phase:
NA
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 schizoph...
Detailed Description
Approximately 30% of patients with schizophrenia have symptoms that persist despite multiple antipsychotic medication trials including clozapine, and there is currently no evidence-based treatment opt...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
June 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT05259306
Start Date
June 1 2026
End Date
June 1 2028
Last Update
May 30 2025
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016