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Ultrasound zaps depression? tiny trial tests new brain treatment

NCT ID NCT06013384

Symptom relief Sponsor: Medical University of South Carolina Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This small pilot study tested whether low-intensity focused ultrasound can safely ease symptoms in people with treatment-resistant depression. The device targets a brain region linked to mood. Only 1 person was enrolled, and the trial is currently suspended, so results are very limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Low-intensity focused ultrasound pulsation (device)
What this could lead to
If it works, this could point toward a new, non-invasive way to treat severe depression that hasn't responded to other therapies.
What could go wrong
This is a very early, tiny pilot study with only 1 participant and the trial is currently suspended. Results may not apply to others, and the approach may not prove effective or safe in larger studies.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

1 person

The number who actually took part.

Started

Feb 2024

Expected to finish

Jun 2028

An estimate. End dates often move.

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 70 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: * Male or female * Age 18-70 * Normal or corrected-to normal vision and hearing * Primary diagnosis of major depressive disorder, moderate/severe per DSM-5 (MADRS \>20) * The duration of the illness must exceed one year * Must be medically stable as determined by investigator * Patient must have attempted and failed treatment with at least 2 SSRI and 1 augmentation * History of rTMS is permitted, but not required Exclusionary criteria: * Diagnosis of primary DSM-5 depressive disorder other than MDD * Anxiety disorders such as GAD are permitted as long as MDD is primary * Diagnosis of schizophrenia or bipolar disorder * Current use of any non-prescribed psychoactive medications or drugs (aside from medications for treatment of MDD) * Contraindication to enter the MRI environment. * Pregnancy (or suspected/possible pregnancy or plan to become pregnant in the short term). * Urine Pregnancy Test: If the subject is a woman of childbearing potential and /or a man capable of fathering a child before, during, and/or after participation precaution should be taken. Examples of acceptable methods of birth control for participants involved in the study includes: birth control pills, patch, IUD, condom, sponge, diaphragm with spermicide, or avoiding sexual activity that could cause the subject to become pregnant. * Inability to adhere to treatment schedule. * Initiation of new antidepressant treatment at the time of study randomization.

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Conditions

The condition(s) this trial relates to.

Depressive Disorder, Treatment-Resistant major depressive disorder

As listed by the trial registrant

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

Major depressive disorder Treatment-resistant depression

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • 30 Bee Street

    Charleston, South Carolina, 29403, United States

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