RecruitingPhase 1NCT07113665

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

Phase I Trial of MR-guided Focused Ultrasound (MRgFUS) Bilateral Capsulotomy for the Treatment of Refractory Anorexia Nervosa With Co-morbid Obsessive Compulsive Disorder or Major Depressive Disorder


Sponsor

Sunnybrook Health Sciences Centre

Enrollment

10 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to evaluate the safety and initial clinical effectiveness of MRI-guided focused ultrasound (MRgFUS) thermal ablation (capsulotomy) in patients with treatment-refractory anorexia nervosa (AN) and comorbid obsessive-compulsive disorder (OCD) and major depressive disorder (MDD). The main questions it aims to answer are: 1. Can MR-guided focused ultrasound capsulotomy be safely delivered through an intact skull in patients with treatment-refractory anorexia nervosa and comorbid OCD and/or MDD, with a safety and side-effect profile comparable to traditional radiofrequency neurosurgical approaches? 2. Does MRgFUS capsulotomy produce clinical outcomes comparable to open surgical ablative procedures-specifically, improvements in anxiety, mood, quality of life, anorexia nervosa psychopathology, habit formation, and weight-in patients with treatment-refractory anorexia nervosa? Participants will: 1. Undergo baseline imaging and clinical assessments 2. Receive a single MRgFUS capsulotomy targeting the ALIC 3. Be monitored for 24 months post-treatment to assess adverse events, quality of life, and symptom changes using standardized clinical and neuropsychiatric measures


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a non-invasive brain procedure called MR-guided focused ultrasound bilateral capsulotomy — which uses focused sound waves guided by MRI to modify specific brain circuits — as a treatment for severe, long-standing anorexia nervosa that has not responded to any other treatment. This is a last-resort option for people who have been very ill for many years. **You may be eligible if...** - You are between 18 and 65 years old - You have anorexia nervosa along with OCD and/or major depressive disorder (diagnosed by DSM-5) - Your illness has been treatment-resistant, meaning: it has lasted more than 10 years with less than 3 months of remission, OR you have had at least three unsuccessful hospital-based treatment attempts, OR you have needed at least two emergency or involuntary re-feeding episodes over at least two years - You are able to give informed consent and make medical decisions **You may NOT be eligible if...** - You have unstable heart disease (such as recent heart attack, uncontrolled heart failure, or arrhythmia) - Your body weight is too low to safely undergo the procedure - You have metal implants or other conditions incompatible with MRI - You have active suicidal intent - You have severe cognitive impairment preventing informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEExAblate Neuro 4000

The ExAblate Neuro 4000 is an MRI-guided focused ultrasound (MRgFUS) system designed to perform noninvasive thermal ablation of targeted brain tissue. In this study, the ExAblate Neuro 4000 will be used to perform a bilateral capsulotomy by ablating the anterior limb of the internal capsule (ALIC) in patients with treatment-refractory anorexia nervosa (AN) and comorbid obsessive-compulsive disorder (OCD) and/or major depressive disorder (MDD). The procedure will be conducted under real-time MRI guidance and thermometry to ensure accurate targeting and controlled thermal delivery. This study aims to evaluate the safety, feasibility, and preliminary clinical benefit of MRgFUS in improving psychiatric symptoms and quality of life in this patient population.


Locations(1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

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NCT07113665