Personalized Ultrasonic Brain Stimulation for Depression

Personalized Ultrasonic Brain Stimulation for Depression: A Pilot Study of Target Engagement and Mood Effects

NCT05301036•University of Utah

Summary

This study will evaluate a new form of non-invasive brain stimulation for individuals with depression. Personalized low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychological and physiological monitoring. A well-tolerated stimulation protocol will then be selected for subsequent testing in a blinded randomized sham-controlled cross-over trial to evaluate brain target engagement using magnetic resonance imaging.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age 18-65, any gender
•2. Primary diagnosis of major depressive disorder or bipolar disorder
•3. Current moderate-to-severe depressive episode, without psychotic features, lasting at least 2 months
•4. Self-rated 16-item Quick Inventory of Depressive Symptomatology (QIDS) total score \> 10
•5. Stated willingness to comply with all study procedures and avoid changes to psychiatric treatments (medications, psychotherapy) for the duration of the study
•6. For females of reproductive potential: negative pregnancy test or use of highly effective contraception for at least 1 month prior to baseline; agreement to use such a method throughout the study
•7. Capacity to provide informed consent; provision of a signed and dated consent form

Exclusion Criteria

•1. History of serious brain injury or other neurologic disorder
•2. Poorly managed general medical condition
•3. Pregnant or breast feeding
•4. Implanted device in the head or neck
•5. MRI intolerance or contraindication
•6. Brain stimulation (e.g., ECT, TMS, VNS) in the past month
•7. Suicidal ideation (Columbia Suicide Severity Rating Scale screen item #2, past month)
•8. Lifetime history of a serious suicide attempt
•9. Moderate-to-severe substance use disorder (past 3 months)
•10. Obsessive compulsive disorder (past month)
+5 more criteria

Locations (1)

University of Utah

Salt Lake City, Utah, United States

Key Dates

Start Date

July 15, 2022

Primary Completion Date

July 14, 2024

Completion Date

December 14, 2024

Last Updated

August 9, 2024

Enrollment

ESTIMATED participants

Conditions

Major Depressive Episode

Interventions

Diadem prototype

DEVICE

University of Iowa Interventional Psychiatry Service Patient Registry

NCT04480918

Treatment Resistant DepressionMajor Depressive Episode+5 more

View study

RECRUITING

Presynaptic Imaging in Major Depressive Episodes After COVID-19

NCT06086366

Long COVIDMajor Depressive Disorder+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 9, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Personalized Ultrasonic Brain Stimulation for Depression

Inclusion Criteria

Exclusion Criteria

University of Iowa Interventional Psychiatry Service Patient Registry

Presynaptic Imaging in Major Depressive Episodes After COVID-19

Metabolomics During ElectroConvulsivoTherapy

ALTO-100 in Bipolar Disorder With Depression (BD-D)

Patient-oriented Randomized Pragmatic Feasibility Trial with RTMS in Depression and Anxiety

Accelerated Intermittent Theta Burst in Treatment-Naive Adolescents