Focused Ultrasound
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Testing focused ultrasound for use of treating major depression

Focused ultrasound trial

North American first: Sunnybrook researchers investigating scalpel-free brain surgery for the treatment of major depression

For the first time in North America, researchers at Sunnybrook are investigating the safety and effectiveness of using MRI-guided focused ultrasound to help patients with treatment-resistant major depression.

Read the news release »


Frequently asked questions

What is Focused Ultrasound and how is it used for treatments in the brain?

Focused ultrasound (FUS) is an incision-free, image-guided technology that targets specific areas of the brain using high frequency ultrasound waves.

The technology uses multiple sources of ultrasound energy, arranged in a specially designed helmet, to target areas deep within the brain.

At very high frequencies, ultrasound energy can be focused with precision to targets as small as one millimeter, and generate high temperatures creating lesions at a desired focal point.

The ability to focus ultrasound energy non-invasively, through the human skull was largely pioneered by scientists at Sunnybrook Health Sciences Centre. This work created a spring-board for the development of new therapeutic applications, by enabling surgeons and scientists safe and precise access to deeper brain structures, without opening the skull. Sunnybrook has become a global leader in FUS research and clinical trials.

Is this a cure for depression?

No. At this time, focused ultrasound is not a cure for depression and is still being tested. In this Phase I trial, researchers are currently investigating the safety and effectiveness of focused ultrasound to help patients with treatment-resistant major depression.

Will this help me / my family member?

The goal of this phase one trial is to investigate the safety and effectiveness of using MRI-guided focused ultrasound in the treatment of depression.

Whether FUS will help improve a patient’s depression, is being investigated, as participants in the trial will be assessed for severity of depression and level of functioning at 1 month, 3 months, 6 months and 12 months.

What is treatment-resistant major depression?

Major depression is marked by feelings of severe despair that persist over time. It is the most severe form of the illness. Patients with major depression who do not respond to existing standard treatment therapies such as talk therapy, behavioural therapy or medication, are considered to have treatment-resistant major depression.

How many people are affected by treatment resistant major depression?

About 10% of people with recurrent major depression, or 1.2-1.4% of the total population, will have treatment resistant major depression. In Ontario alone that represents around 160,000-190,000 people.

Who is this trial for?

Phase I of this trial is open to Canadian residents and will involve six patients with treatment-resistant major depression, ages 25-80 years old. They will undergo one round of focused ultrasound, and then assessed for severity of depression and level of functioning at 1 month, 3 months, 6 months and 12 months.

» Read: first-person blog post from one of the first North American trial participants

What part of the brain is affected?

In this trial, focused ultrasound will be used to cause a lesion in region of the brain called the anterior limb of the internal capsule, to disrupt a pathway of the brain that has been established as being active in depression. This pathway is considered to be a “highway” connecting the frontal lobes to the emotional centres of the brain, including the amygdala and hippocampus.

Is making lesions in the brain dangerous?

For half a century, lesions have been made in the brain for depression, which typically required a surgical operation, which is more invasive than focused ultrasound, which is an incision-free, image-guided technology that targets specific areas of the brain using high frequency ultrasound waves.

Trial participants are observed and monitored very closely during the procedure and observed.

What are the risks?

All procedures carry risk. In this procedure, the main risks include, bleeding and swelling of the tissue in and around the area of the brain that has been lesioned. The patient is closely monitored by a large interdisciplinary group including neurosurgeons, an anesthetist, radiologist, neurologist and physicist. The research is carried out within a hospital environment with access to care and leading brain health specialists.

If found effective, who will this research help?

If this phase of the trial proves to be successful, the researchers will consider furthering their testing to phase 2 and potentially include a greater number of participants.

Who do I contact for more information?

Please note:

  • Enrolment in this focused ultrasound trial is limited to patients with treatment-resistant major depressive disorder, who are 25-80 years old and Canadian residents.

Fill out our online form to find out more about a focused ultrasound clinical trial at Sunnybrook, or email or leave a voicemail on our phone line (416-480-6100, ext. 3773) with your contact information.


If you are suffering, please know that you are not alone and help is available. We suggest connecting with your health-care provider, who can help navigate available resources and support in your area. Help is also available 24/7 through your local distress centre: sunnybrook.ca/gethelp