University of Minnesota
SERENE is an experimental study evaluating low-intensity focused ultrasound neuromodulation of cognitive control circuitry in adults with a lifetime history of suicide attempt or suicidal ideation, but without current suicidality. Participants will complete screening, cognitive control tasks, MRI/fMRI, ecological momentary assessments, and low-intensity focused ultrasound neuromodulation using the DIADEM system. The study will examine whether low-intensity focused ultrasound (LIFU) neuromodulation changes cognitive control performance measured by the Multi-Source Interference Task (MSIT) and EEG event-related spectral power in the alpha and theta frequency bands. The study will also examine the time course of LIFU effects and explore whether changes in cognitive control circuitry relate to self-reported experiences, including mood, anxiety, psychosis symptoms, suicidal ideation, and emotion regulation.
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 baseli…
Inclusion Criteria: * Lifetime history of suicide attempt or suicidal ideation, as determined by the Columbia-Suicide Severity Rating Scale * Score in specified ranges on measures of cognitive control behavior and/or cognitive control circuit function * No current suicide ideation or behavior within the past 3 months, as determined by the Columbia-Suicide Severity Rating Scale * Age 18 to 65 years * Speaks and understands English * Primary user of a smartphone Exclusion Criteria: * Under age 18 * Neurological disorder that may affect fMRI scan results or cause reaction to LIFU to differ fro…
Low-intensity focused ultrasound neuromodulation will be delivered using the SPIRE DIADEM device. LIFU will be applied to subregions of deep brain circuitry involved in cognitive control, including regions within the dorsal or ventral internal capsule, surrounding striatal nuclei, and/or connected brain areas. Stimulation will be delivered by trained study staff according to device safety and screening procedures.
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