Focused Ultrasound for Anorexia

Overseen By Anusha Baskaran, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Sunnybrook Health Sciences Centre

Must not be taking: Anti-arrhythmics, Anticoagulants, Antiplatelets, others

Disqualifiers: Unstable cardiac, MRI contraindications, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 1 day

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for individuals with severe anorexia nervosa that has not improved with other treatments. It employs MRI-guided focused ultrasound, a non-invasive procedure, to target specific brain areas, aiming to alleviate symptoms related to anorexia, anxiety, mood, and overall quality of life. The trial seeks participants who have experienced anorexia for over 10 years, along with obsessive-compulsive disorder or major depression, and have tried at least three different treatments without success. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative treatment.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but you cannot be on anticoagulant or antiplatelet therapy within one week of the procedure, or drugs that increase bleeding risk within one month of the procedure.

What prior data suggests that this MRI-guided focused ultrasound capsulotomy is safe for patients with treatment-refractory anorexia nervosa?

Research has shown that MRI-guided focused ultrasound (MRgFUS) capsulotomy could be a promising treatment for mental health conditions like anorexia nervosa. In previous studies, this treatment helped patients with severe anorexia gain weight, particularly those in critical health situations.

Although researchers continue to study MRgFUS, it has shown potential for treating various psychiatric disorders with fewer side effects than traditional surgery. These studies suggest that MRgFUS might be a safer option than open surgery, with side effects similar to other less-invasive procedures. However, since this is early-stage research, more studies are needed to fully understand its safety.

This trial phase aims to determine the safety of MRgFUS for people, as it treats the brain through the skull without making a cut. Researchers will closely monitor participants for 24 months to check for any side effects and to assess their response to the treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Magnetic Resonance-Guided Focused Ultrasound (MRgFUS) for anorexia because it offers a novel approach for individuals who haven't responded to traditional treatments like cognitive behavioral therapy, medications, or nutritional counseling. Unlike these standard treatments, MRgFUS targets the brain directly, using focused ultrasound waves to create precise, controlled lesions in the anterior limb of the internal capsule, which is involved in mood and behavior regulation. This method is non-invasive and allows real-time monitoring, potentially providing a safer and more targeted alternative for those with severe, treatment-resistant anorexia accompanied by obsessive-compulsive disorder or major depressive disorder.

What evidence suggests that MRI-guided focused ultrasound capsulotomy is effective for treatment-refractory anorexia nervosa?

Studies have shown that MRI-guided focused ultrasound (MRgFUS) capsulotomy can help patients with severe anorexia gain weight, particularly when their condition is life-threatening. This trial will evaluate MRgFUS in participants with treatment-refractory anorexia nervosa (AN) and comorbid obsessive-compulsive disorder (OCD) and/or major depressive disorder (MDD). MRgFUS precisely targets and alters specific brain areas linked to these conditions, potentially improving mood, anxiety, and overall quality of life. Although more research is needed, early findings suggest this method could benefit those who haven't improved with other treatments. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for individuals with severe anorexia nervosa who also have OCD or major depression and haven't improved with standard treatments. Participants must be able to undergo MRI scans and focused ultrasound procedures, but specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

I am between 18 and 65 years old.

I am capable of understanding and agreeing to the trial's requirements.

Treatment refractoriness indicated by duration of illness more than 10 years with no more than three months of remission in terms of weight, at least three unsuccessful expert hospital-based treatment attempts, a pattern of increased medical instability requiring at least two episodes of emergency/involuntary re-feeding lasting at least two years

Exclusion Criteria

I have a condition like diabetes that affects how I eat or digest food.

Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.

I do not have severe heart problems like recent heart attacks or uncontrolled high blood pressure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Baseline Assessment

Participants undergo baseline imaging and clinical assessments, including psychiatric assessment, physical and nutritional status review, MRI imaging, and surgical eligibility screening

1-2 weeks

1 visit (in-person)

Treatment

Participants receive a single MRgFUS capsulotomy targeting the anterior limb of the internal capsule (ALIC)

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with evaluations at immediate post-op, 1, 3, 6, 12, 18, and 24 months

24 months

7 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Magnetic Resonance-Guided Focused Ultrasound Bilateral Capsulotomy

Trial Overview The study tests a procedure called MRgFUS capsulotomy, which uses MRI-guided focused ultrasound through the skull to target brain areas involved in anorexia, OCD, and depression. It aims to see if this non-invasive method is safe and can improve patients' symptoms over two years.

How Is the Trial Designed?

Group I: MR- guided Focused Ultrasound Capsulotomy Experimental Treatment 1 Intervention

Participants in this arm will undergo a single MRI-guided focused ultrasound (MRgFUS) thermal ablation procedure targeting the anterior limb of the internal capsule (ALIC). The procedure is performed using the ExAblate 4000 MRgFUS system, with real-time MR thermometry to ensure precise lesioning. This intervention is intended for individuals with treatment-refractory anorexia nervosa (AN) and comorbid obsessive-compulsive disorder (OCD) and/or major depressive disorder (MDD) who meet surgical eligibility criteria. All participants will complete standardized psychiatric and quality of life assessments at baseline and follow-up time points up to 24 months post-treatment to evaluate safety, feasibility, and preliminary clinical efficacy.

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07113665

Magnetic Resonance-Guided Focused Ultrasound Bilateral ... The goal of this clinical trial is to evaluate the safety and initial clinical effectiveness of MRI-guided focused ultrasound (MRgFUS) thermal ablation ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28945886/

Long-Term Follow-up Study of MRI-Guided Bilateral ... Capsulotomy enabled patients with refractory AN to normalize their weight, especially those in life-threatening conditions.

3. withpower.com withpower.com/trial/phase-1-obsessive-compulsive-disorder-7-2025-82c24

Focused Ultrasound for Anorexia The goal of this clinical trial is to evaluate the safety and initial clinical effectiveness of MRI-guided focused ultrasound (MRgFUS) thermal ablation ...

4. fusfoundation.org fusfoundation.org/content/images/pdf/FUSF-Psychiatric-Workshop-white-paper.pdf

Focused Ultrasound Psychiatric Workshop Summary Bilateral thermal capsulotomy with MRgFUS for OCD has been developed and implemented in human clinical trials.4 The results of the treatment ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X23017643

Neuroethical implications of focused ultrasound for ... MR-guided focused ultrasound is a promising intervention for treatment-resistant mental illness, and merits contextualized ethical exploration.

6. fusfoundation.org fusfoundation.org/posts/focused-ultrasound-and-psychiatric-disorders/

Focused Ultrasound and Psychiatric Disorders Focused ultrasound holds promise for treating anorexia nervosa, aggression and disruption, and Tourette's syndrome.