Clinical Research Studies

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. We aim to enroll N=12 participants with schizophrenia in a random order, sham-controlled crossover trial of a single session of PLIFUS counterbalanced with a single sham sonication session, one week apart. After the participant provides written informed consent, a medical and psychiatric evaluation will be performed to determine eligibility for inclusion in the study, followed by a structural MRI to guide neuro-navigation. The first intervention visit will include a 10 minute PLIFUS sonication or sham sonication, preceded and followed by fMRI and an exit medical examination. Psychiatric symptoms will be assessed immediately prior to sonication/sham, during sonication/sham and 5 minutes, 30 minutes, 60 minutes, 1 day and 7 days after sonication/sham. The second intervention visit will consist of sonication or sham preceded and followed by fMRI in addition to symptom assessments and post-sonication/sham medical evaluation. Participants will be closely monitored during and after procedures for tolerability and adverse effects, including 1 and 7 day follow-up visits. 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. If PLIFUS effects on fMRI and symptom ratings are not detected in the first 4 completers, subsequent participants will receive 3 sessions over 5 days.