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Sound waves against binge eating: new brain zap trial launches

NCT ID NCT06485687

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
Paused for now. It may or may not start again.
Ongoing This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early study tests whether a low-intensity focused ultrasound device can safely calm brain areas linked to food cravings in people with binge eating disorder. Fifteen adults with moderate to severe binge eating will receive a single session. The main goal is safety, but researchers will also track changes in cravings and eating habits.

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 (LIFU) device
What this could lead to
If it works, this could point toward a non-invasive brain stimulation treatment to reduce food cravings and binge eating episodes.
What could go wrong
This is a very early feasibility study with only 15 people, focused on safety. It may not show any benefit, and effects on cravings are secondary.

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

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Dec 2027

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

22 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: * Males and non-pregnant females, 22 - 65 years of age. * Participant meets DSM-5 criteria for moderate to extreme BED. * Weight ≤450lb to accommodate in MRI. * Shoulder width of ≤65 inches to accommodate in MRI. * The neuromodulation targets are visible on MRI for target selection. * Participant is able and willing to give informed consent. Exclusion Criteria: * Unable to undergo MR-imaging because of implanted pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent make-up or small metal fragments in the eye that welders and other metal workers may have, or if candidates are uncomfortable in small spaces (have claustrophobia). * Participants with more than 30% of the skull area traversed by the sonication pathway are covered by scars, scalp disorders (e.g., eczema), atrophy of the scalp, or implanted objects in the skull or the brain. * Participants with known untreated or unstable cardiac status or hypertension * Evidence of substance (alcohol or other drug) use disorder during the previous 12 months (assessed via SCID-5). * Past or present diagnosis of schizophrenia, psychotic disorder or bipolar disorder (assessed via SCID-5) * Participant who is currently participating in another clinical investigation with an active treatment arm. * Use of any medications that, in the opinion of the Investigator, may put the participant at higher risk for AEs, or impair the participant's ability to perform complete study procedures. * Participant is considered to be a poor surgical or study candidate, which may include, but is not limited to the following: any medical, social, or psychological problem that could complicate the required procedures and evaluations of the study in the judgment of the investigator. * Participant is pregnant/lactating or planning to be pregnant.

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Conditions

The condition(s) this trial relates to.

binge eating disorder Binge-Eating Disorder

As listed by the trial registrant

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

Contacts and locations

Locations

  • West Virginia University: Rockefeller Neuroscience Institute

    Morgantown, West Virginia, 26506, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.