Cure My Disease

Don't miss your cure!

 Log in / Sign up

Sound waves against addiction: helmet zaps brain to curb substance use

NCT ID NCT07684976

Disease control 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This trial tests whether a helmet that delivers focused ultrasound waves can safely change brain activity in people with moderate-to-severe substance use disorder who haven't responded to medication. Participants receive two MRI-guided sessions targeting brain regions linked to addiction. The study aims to see if this approach reduces substance use and is safe.

What this could mean

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

Active substance
Next Generation Dome Helmet (NGDH) — a device that delivers low-intensity focused ultrasound to specific brain areas
What this could lead to
If successful, this could offer a non-invasive, drug-free way to reduce substance use severity in people with treatment-resistant addiction.
What could go wrong
This is an early feasibility study with only 20 participants, so results may not apply broadly. The treatment may not reduce substance use, and risks from brain ultrasound are still being assessed.

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.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 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: 1. Must be deemed to have capacity to provide informed consent (determined by the investigator) 2. Age between 18 to 70 (inclusive) 3. Diagnosis of SUD (cannabis, alcohol, ketamine, stimulant, opioid or nicotine/tobacco use disorder) in the moderate to severe range according to the DSM-5 4. Previous ≥2 pharmacotherapy trials for the diagnosed SUD according to guideline-concordant, evidence-based care 5. On a stable regimen of their psychiatric medications for 30 days before enrolment. Exclusion Criteria: 1. Pregnant or intending to be pregnant during the study 2. Known active seizure disorder, significant head injury with an imaging verified lesion 3. Medical illness that is deemed to be unstable or may confound the effects of the intervention 4. Not eligible for 3-Tesla MRI (i.e. MRI-incompatible pacemaker) 5. Unable to reliably attend the required screening, treatment, and follow up appointments. 6. Severe claustrophobia, identified by the subject to be a limiting factor preventing MRI. 7. Scores 18 or below on Montreal Cognitive Assessment (MoCA) 8. Weighs 250 lbs or more.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Substance use disorder (SUD) are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

substance-related disorder

As listed by the trial registrant

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

Substance use disorder (SUD)

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

More trials for these conditions

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