SERENE Low-Intensity Focused Ultrasound for Cognitive Control

SERENE is an experimental study designed to test a personalized, non-invasive neuromodulation technique to investigate the neural basis of cognitive control. The study will enroll adults with a lifetime history of suicide attempt or suicidal ideation, but without current suicidal ideation or behavior. Participants will be screened using the Columbia-Suicide Severity Rating Scale to confirm suicide history and exclude current suicidality. Participants will also complete MRI/fMRI-based cognitive control screening to identify cognitive control circuit function. Participants will complete baseline cognitive and self-report assessments, including computerized cognitive tasks and clinical/self-report measures. Ecological momentary assessments will be completed before and after neuromodulation to assess symptoms and daily-life experiences related to cognitive control, including mood, anxiety, psychosis-related symptoms, suicidal ideation, and emotion regulation. The study intervention is low-intensity focused ultrasound neuromodulation delivered using the DIADEM system. LIFU will be applied to deep brain regions involved in cognitive control, including subregions of the internal capsule and connected brain regions. During LIFU visits, participants will complete the Multi-Source Interference Task to assess cognitive control. EEG and fMRI may also be collected to evaluate neurocircuitry changes associated with LIFU. The primary objective is to evaluate the effect of LIFU on cognitive control and associated circuitry. The study will also examine the time course of this effect, whether responses differ by baseline cognitive control circuit function, and whether changes in circuitry relate to self-reported experiences.