Low-Intensity Focused Ultrasound for Cognitive Control
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Michael V Bronstein, PhD
Principal Investigator
University of Minnesota
Alik S Widge, MD,PhD
Principal Investigator
University of Minnesota
Are You a Good Fit for This Trial?
This trial is for adults who have had suicidal thoughts or attempted suicide in the past, but are not currently experiencing suicidal thoughts. Participants should be able to complete cognitive tasks and MRI scans.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- DIADEM Low-Intensity Focused Ultrasound Neuromodulation
Trial Overview
The study tests whether low-intensity focused ultrasound (using the DIADEM system) can safely change brain activity related to thinking and self-control. It uses brain scans, EEGs, and cognitive tasks before and after treatment.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will receive low-intensity focused ultrasound neuromodulation using the DIADEM device while completing cognitive control tasks. Stimulation may be applied to subregions of the internal capsule and connected brain regions to identify targets that modulate cognitive control performance or circuitry.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor
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