What this study is
Simplified from ClinicalTrials.govTesting low-intensity focused ultrasound brain stimulation (DIADEM system) to see whether it changes cognitive control, the mental skill of staying focused when thoughts or cues conflict, in adults ages 18 to 65 who have had a suicide attempt or suicidal thoughts in the past but not currently.
Read the original summary from ClinicalTrials.gov
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.
What's being tested
- DIADEM Low-Intensity Focused Ultrasound Neuromodulation
Intervention · DEVICE
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.
Study details
- Official title
- Suicide-related Experience Reduction Via Enhancement of Neuroplasticity
- Sponsor
- University of Minnesota
- Conditions
- Suicidal Ideation · Cognitive Control · Neurocognitive Function
- Enrolling
- 100 people
- Starts
- 2027-01-01
- Est. completion
- 2028-09-20
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 65 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- Under age 18
- Neurological disorder that may affect fMRI scan results or cause reaction to LIFU to differ from healthy adults
- Regular use of psychoactive medication, except PRN use if the participant is willing and able to abstain during the study period
- Psychiatric hospitalization within the past 3 months
- Contraindication to fMRI scanning, including claustrophobia, unremovable piercings, pregnancy, medical devices such as pacemakers, or a movement or sleep disorder
- Pregnant or may have reason to believe they are pregnant
- Diagnosis of certain psychiatric conditions, such as schizophrenia, bipolar disorder, or a developmental disorder other than ADHD
- Any other neurological, autoimmune, or medical disorder that may inhibit participation
- Children
- Pregnant women/persons
- Fetuses
- Neonates
- Prisoners
- Adults lacking capacity to consent or adults with diminished or fluctuating capacity to consent
- Non-English speakers
- Individuals unable to read
- Employees of the researcher
- Students of the researcher
- Individuals approached during a stressful situation, such as an emergency room setting or childbirth
- Individuals with fear of negative consequences for not participating
- Any other circumstance that could increase vulnerability to coercion or exploitation
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMasonic Institute for the Developing Brain
Minneapolis, Minnesota, United States
- Michael V Bronstein, PhD · Contact781-492-5644brons139@umn.edu
Study team
Sponsor
University of Minnesota
Study ID STUDY00028755
Principal investigator
Michael V Bronstein, PhD
University of Minnesota
Study director
Alik S Widge, MD,PhD
University of Minnesota
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.