RecruitingPHASE1INTERVENTIONAL

Magnetic Resonance-Guided Focused Ultrasound Bilateral Capsulotomy for Refractory Anorexia Nervosa With Comorbid Obsessive Compulsive Disorder or Major Depressive Disorder

This study is testing a new, gentler technique called MRI-guided focused ultrasound (MRgFUS) for people with very serious anorexia nervosa, particularly when they also have severe obsessive-compulsive disorder (OCD) or major depression. The treatment aims to target a specific tiny part of the brain without needing traditional surgery. Researchers want to know if this treatment is safe and if it can help improve symptoms of anorexia nervosa, anxiety, mood, and overall quality of life. Participants will have the treatment and then be carefully watched for two years to see how they are doing and if there are any side effects. This is a small, early-stage study to gather initial information.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Sunnybrook Health Sciences Centre

Enrolment target

Start

01 Aug 2025

Estimated completion

01 Aug 2028

Anorexia Nervosa (DSM-IV Revised Criteria)

What is this study about?

This research study is exploring a new way to help people who have a very severe form of anorexia nervosa, especially if they also struggle with obsessive-compulsive disorder (OCD) or major depression. For some individuals, standard treatments don't work well enough, and their condition continues to be very difficult to manage. This study focuses on these particular situations, looking for new possibilities.

The new technique being tested is called MRI-guided focused ultrasound (MRgFUS). Think of it like using very precise sound waves, guided by detailed MRI scans, to target a tiny, specific area deep inside the brain. The aim is to gently change how this area works, which might help reduce severe symptoms of anorexia nervosa, OCD, and depression. Unlike older surgical methods, this technique doesn't involve cutting the skin or opening the skull. The study wants to find out if this method is safe and if it can bring about real improvements in people's lives.

Researchers will carefully monitor people who take part for two years after the treatment. They will look for any side effects and track how symptoms like anxiety, mood, and eating-related thoughts change over time. The goal is to see if this focused ultrasound treatment can offer a safe and effective option for those who haven't found relief with other treatments, potentially leading to a better quality of life and healthier habits.

Key takeaways

It's a study for severe anorexia nervosa with OCD or major depression.
It tests a new, non-invasive focused ultrasound brain treatment.
The main goals are to check safety and see if symptoms improve.
Participants will have one treatment and be monitored for two years.
It's a small, early-stage study (Phase 1) focused on initial findings.

Who may be eligible?

This study is looking for both men and women between 18 and 65 years old. You would need to have been diagnosed with anorexia nervosa, as well as obsessive-compulsive disorder (OCD) or major depression.

Importantly, your anorexia nervosa must be considered 'treatment-resistant.' This means you've had it for a long time (more than 10 years with little improvement), haven't responded well to at least three attempts at expert hospital treatment, or have needed emergency re-feeding at least twice in the last two years due to medical instability.

There are also some health conditions that would prevent you from taking part, such as certain heart problems, having metal implants that aren't safe for MRI scans (like some pacemakers), major bleeding risks, a recent stroke, or being on certain blood-thinning medications. You also need to be able to understand the study and agree to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 65 years old?
Have you been diagnosed with anorexia nervosa, and also OCD or major depression?
Has your anorexia been very severe and long-lasting, with other treatments not working well?
Do you have any heart problems that might prevent you from taking part?
Are you able to have an MRI scan (e.g., no incompatible metal implants)?
Are you currently taking strong blood-thinning medications?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the first step involves a full check-up. This will include mental health assessments, a review of your physical health and nutrition, and MRI scans to prepare for the treatment. You will also have a chat with the psychiatrist and surgeon to make sure the study is right for you.

The main part of the study is a single treatment session using the focused ultrasound machine. During this, you'll be guided by MRI scans. After the treatment, you won't be left alone. You'll have regular follow-up visits and assessments over the next two years. These check-ups will happen immediately after the treatment, and then at 1, 3, 6, 12, 18, and 24 months. These visits are important for the researchers to monitor your safety, how you're feeling, and any changes in your symptoms and quality of life. There are no drugs or other treatments provided as part of the study itself beyond the focused ultrasound.

Potential risks and benefits

Taking part in this study could potentially offer a new treatment for severe anorexia nervosa and related conditions, especially if other treatments haven't worked for you. It might improve your mood, anxiety, quality of life, and overall health. However, as with any new treatment, there are potential risks, including side effects from the focused ultrasound, which the researchers will explain in detail. These could be similar to those seen with traditional brain手術. Your safety will be closely monitored throughout the study. You always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Sunnybrook Health Sciences Centre
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is focused ultrasound?

It's a way to use very precise sound waves, guided by MRI scans, to target a tiny area in the brain without needing surgical cuts.

Is this a new type of treatment?

Yes, it's a new approach being tested for severe anorexia nervosa, especially when combined with OCD or depression.

Will I have to stay in hospital?

The information provided doesn't specify an overnight stay, but you will have the treatment and then regular follow-up visits over two years.

What kind of people are you looking for?

Adults aged 18-65 with very severe, long-lasting anorexia nervosa that hasn't responded to other treatments, and who also have OCD or major depression.

What happens if I change my mind?

You are free to withdraw from the study at any point, and it won't affect your ongoing medical care.

How to find out more

Nir Lipsman, MD, PhD, FRCSC

nir.lipsman@sunnybrook.ca 416-480-6954 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.