Focused Ultrasound Brain Procedure Tested in Severe Anorexia Nervosa With Other Conditions
Tests a focused ultrasound brain procedure in adults with severe anorexia nervosa and related conditions.
Plain-language title generated from the registry record
Registry title: Magnetic Resonance-Guided Focused Ultrasound Bilateral Capsulotomy for Refractory Anorexia Nervosa With Comorbid Obsessive Compulsive Disorder or Major Depressive Disorder
Key facts
- Where
- Toronto, CanadaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07113665, who can take part
Where in Canada
- Sunnybrook Health Sciences CentreToronto, CanadaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sunnybrook Health Sciences Centre
- Trial code
- NCT07113665
- Record updated
- 14 August 2025
- Original description
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:Read full original descriptionShow less
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
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
Inclusion: Men and women ≥18 and ≤65 years of age, inclusive; Patients who are competent and willing to give consent and able to attend study visits, as determined by both study Psychiatrist and the surgeon; DSM-V diagnosis of Anorexia Nervosa, with co-morbid diagnosis of OCD and/or Major depressive disorder; Treatment refractoriness indicated by any of:; Duration of illness more than 10 years with no more than three months of remission in terms of weight; At least three attempts at expert hospital based treatment that were not successful or where there was no sustained response to treatment; A pattern of increased medical instability requiring at least two episodes of emergency/involuntary re-feeding and lasting at least two years; Ability to provide informed consent/competent to make medical decisions.
Exclusion: Receiving anticoagulant (e.g. warfarin) or antiplatelet (e.g. aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk or hemorrhage (e.g. Avastin) within one month of focused ultrasound procedure; Chemical abuse or dependence within the previous six months; Patients with unstable cardiac status [e.g. Unstable angina pectoris on medication, Patients with documented myocardial infarction within six months, Congestive heart failure requiring medication (other than diuretic), Patients on anti-arrhythmic drugs, Severe hypertension (diastolic BP > 100 on medication)]; Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc; Cerebrovascular disease (e.g. CVA within 6 months) or history of intracranial hemorrhage; Presence of significant cognitive impairment; History of psychosis on clinical evaluation; Presence of a metabolic pathology interfering with eating or digestion (e.g. diabetes); Laboratory biochemical evidence of abnormal bleeding and/or coagulopathy, including risk factors for intraoperative or postoperative bleeding (platelet count less than 100,000 per cubic millimeter or abnormal INR); Currently pregnant (as determined by history and serum HCG) or lactating; Untreated, uncontrolled sleep apnea; Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment; Are participating or have participated in another clinical trial in the last 30 days; Patients unable to communicate with the investigator and staff; Patients with brain tumors already known or revealed on pretreatment MRI; Body mass index (BMI) less than 13.