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Sound waves to the brain: a new hope for Tough-to-Treat OCD?

NCT ID NCT07704632

Symptom relief Sponsor: Sunnybrook Health Sciences Centre Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time

Summary

This study tests whether a special helmet that delivers focused ultrasound can safely and effectively calm overactive brain circuits in people with severe obsessive-compulsive disorder (OCD) that hasn't improved with standard treatments. Participants receive two sessions of this non-invasive brain stimulation, spaced a month apart. The goal is to see if the procedure is safe and if it can reduce OCD symptoms and improve quality of life.

What this could mean

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

Active substance
focused ultrasound delivered via the Next Generation Dome Helmet (NGDH) device
What this could lead to
If successful, this could offer a non-invasive, drug-free option to reduce OCD symptoms in people who haven't responded to standard treatments.
What could go wrong
This is an early feasibility study with only 20 participants, so results may not apply broadly. The procedure carries risks like any brain intervention, and symptom improvement is not guaranteed.

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 20 people

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

Started

Sep 2025

Expected to finish

Sep 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

18 to 85 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. Must be deemed to have the capacity to provide informed consent. 2. Age 18 to 85 years. 3. Diagnosis of obsessive-compulsive disorder according to DSM-5 criteria. 4. Yale-Brown Obsessive Compulsive Scale total score greater than 22. 5. If taking psychiatric medications, must be on a stable regimen for at least 30 days before enrollment. Psychiatric medications will be continued throughout the study. 6. Previous trial of at least two first-line antidepressant agents at an adequate dose and duration, as assessed by two psychiatrists. 7. Previous trial of cognitive behavioural therapy or psychotherapy for OCD for at least 6 weeks. Exclusion Criteria: 1. Pregnant or intending to become pregnant during the study. 2. Substance use disorder, other than cannabis or nicotine use disorder, of moderate severity or greater, or where the substance is the primary substance of concern, according to DSM-5 criteria. 3. Known active seizure disorder or significant head injury with an imaging-confirmed lesion. 4. Unstable medical illness. 5. Not eligible for 3-Tesla MRI, such as due to an MRI-incompatible pacemaker or other implanted device. 6. Unable to reliably attend the required screening, treatment, and follow-up visits. 7. Severe claustrophobia that would prevent MRI scanning. 8. History of a bleeding disorder or coagulopathy. 9. Anticoagulant therapy or use of medications known to increase the risk of hemorrhage within the required washout period before treatment, including: * Antiplatelet agents or vitamin K antagonist anticoagulants within 7 days of treatment * Non-vitamin K oral anticoagulants within 72 hours of treatment * Heparin-derived compounds within 48 hours of treatment

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Conditions

The condition(s) this trial relates to.

obsessive-compulsive disorder obsessive-compulsive personality disorder

As listed by the trial registrant

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

Obsessive compulsive disorder (OCD) Obsessive-compulsive disorder OCD

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

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • Sunnybrook Health Sciences Centre

    RECRUITING

    Toronto, Ontario, M4N 3M5, Canada

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