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Personalized ultrasonic brain stimulation for depression: a pilot study of target engagement and mood effects

NCT ID NCT05301036

NEW Sponsor: University of Utah Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 09, 2026

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

22 people

The number who actually took part.

Started

Jul 2022

Finished

Jul 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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) 11. Posttraumatic stress disorder (past month) 12. Schizophrenia-spectrum disorder (lifetime) 13. Neurocognitive disorder (past year) 14. Personality disorder as a current focus of treatment 15. Clinically inappropriate for participation in the study as determined by the study team

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Conditions

The condition(s) this trial relates to.

major depressive disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Major depressive episode

Contacts and locations

Locations

  • University of Utah

    Salt Lake City, Utah, 84108, United States

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