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Sound waves to the brain could tame bipolar mood swings

NCT ID NCT06482762

Symptom relief Sponsor: Massachusetts General Hospital 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early study tests whether gentle ultrasound waves aimed at the amygdala (a brain region linked to emotion) can help people with bipolar disorder. Twenty adults with bipolar will receive the ultrasound and have brain scans to see if it calms overactive emotion circuits. The goal is to see if this approach is feasible and might reduce depressive symptoms.

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 (device)
What this could lead to
If it works, this could point toward a non-invasive, drug-free way to ease mood symptoms in bipolar disorder.
What could go wrong
This is a very early, small study (20 people) testing feasibility. It may not show clear benefit, and the effects on mood are uncertain.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 20 people

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

Started

Jul 2024

Expected to finish

Dec 2026

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 64 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. Primary diagnosis of BD (can be BD-I or BD-II) 2. Age 18-64 3. Normal or corrected-to normal vision and hearing 4. YMRS ≤ 12 5. BDI ≥ 14 Exclusion Criteria: 1. Active neurological disorder 2. Current psychosis symptoms 3. MRI scan contraindications (e.g., metal implant, claustrophobia, weigh over 250 pounds, etc.) 4. YMRS \> 13 5. BDI \< 14

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Conditions

The condition(s) this trial relates to.

bipolar disorder

As listed by the trial registrant

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

Bipolar

Contacts and locations

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

More trials for these conditions

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