This is a single-site, phase 2, sham-controlled random-order cross-over pilot trial of PLIFUS targeting the right GPi in individuals with schizophrenia. Twelve individuals with schizophrenia who report continuous hallucinations or delusions of mild or greater severity will receive one session of PLIFUS and one session of sham PLIFUS in random order, one week apart. If no effect of PLIFUS is detected on measures of functional connectivity or psychotic symptoms in the first four completers, the trial will be changed to 3 sessions of PLIFUS or sham administered over 5 days.
The primary objectives of this study are to examine the tolerability of pulsed low-intensity focused ultrasound (PLIFUS) and its effects on brain function measured via fMRI functional connectivity and symptom response in individuals with schizophrenia. A neuronavigated single-element piezoelectric device will be utilized to noninvasively deliver transcranial PLIFUS sonication to the right globus pallidus interna, a brain region implicated in schizophrenia. The goal of this pilot study is to establish feasibility and tolerability and to determine whether the sonication procedure produces effects on the imaging biomarker and on symptoms prior to proceeding to therapeutic trials using repeated administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
15
The Sonicator-1000 system will non-invasively deliver ultrasound sonications transcranially that selectively target specific areas of the brain using a neuronavigation system and the participant's MRI brain scan. The sonication parameters follow FDA and Electrotechnical Technical Commission regulation standards for diagnostic and therapeutic ultrasound.
Sham PLIFUS treatment delivers noise and patient experience that is identical to PLIFUS with Sonicator-1000 system.
A total of 5 MRIs will be performed using a Siemens 3T Prisma; one prior to the intervention visit, and one preceding and one immediately after each of the two sonication/sham visits.
NYU Langone Brooklyn
Brooklyn, New York, United States
NYU Langone Health
New York, New York, United States
Change in Globus Pallidus Interna (GPi) Functional Connectivity During PLIFUS Intervention Visit
Change in GPi functional connectivity measured via functional MRI (fMRI) captured pre-sonication and 10 minutes post-sonication during the PLIFUS intervention visit.
Time frame: Immediately pre-sonication and 10 minutes post-sonication at Intervention Visit 1 (Day 0) and Intervention Visit 2 (Day 7)
Change in Auditory Hallucinations Rating Scale (AHRS) Score From Baseline
A 7-item scale developed to measure specific characteristics of auditory hallucinations (frequency, reality, loudness, number of voices, length, attentional salience, distress level). Each item is rated on a separate Likert scale. The total score, ranging from 0 to 44, indicates the overall severity of the hallucinations, with higher scores suggesting more severe symptoms.
Time frame: Baseline, Final Study Visit (Day 14-16)
Change in Delusions Experience Sampling Assessment (DESA) Score From Baseline
A 4-item scale (conviction, distress, preoccupation, disruption) used to assess moment-to-moment experience and detect more rapid changes of delusions. Participants are asked to rate the same delusional belief at the moment on a 7-point Likert scale (1 (not at all) to 7 (very much)). The total score is the sum of responses ranging from 1-28; higher scores indicate more severe symptoms.
Time frame: Baseline, Final Study Visit (Day 14-16)
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