Actively Recruiting
Magnetic Resonance-Guided Focused Ultrasound Bilateral Capsulotomy for Refractory Anorexia Nervosa With Comorbid Obsessive Compulsive Disorder or Major Depressive Disorder
Led by Sunnybrook Health Sciences Centre · Updated on 2025-08-14
10
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Magnetic Resonance-Guided Focused Ultrasound Bilateral Capsulotomy for Refractory Anorexia Nervosa With Comorbid Obsessive Compulsive Disorder or Major Depressive Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women 18 to 65 years of age, inclusive
- Competent and willing to give consent and able to attend study visits, as confirmed by study Psychiatrist and surgeon
- DSM-V diagnosis of anorexia nervosa with comorbid obsessive-compulsive disorder and/or major depressive disorder
- Illness duration more than 10 years with no more than three months of remission in terms of weight; or at least three unsuccessful attempts at expert hospital-based treatment; or increased medical instability requiring at least two emergency/involuntary refeeding episodes over at least two years
- Ability to provide informed consent and make medical decisions
You will not qualify if you...
- Unstable cardiac status including unstable angina on medication, recent myocardial infarction within six months, congestive heart failure requiring medication (other than diuretics), use of anti-arrhythmic drugs, or severe hypertension (diastolic BP > 100 on medication)
- Standard contraindications for MRI such as non-MRI compatible implanted metallic devices including pacemakers or size limitations
- Laboratory evidence of abnormal bleeding or coagulopathy, including platelet count below 100,000 or abnormal INR
- Cerebrovascular disease such as stroke within six months or history of intracranial hemorrhage
- Untreated or uncontrolled sleep apnea
- Use of anticoagulant or antiplatelet therapy within one week of the procedure or drugs increasing hemorrhage risk within one month
- Unable or unwilling to tolerate prolonged stationary supine position during treatment
- Participation in another clinical trial within the past 30 days
- Unable to communicate with study staff
- Significant cognitive impairment
- History of psychosis
- Known or newly found brain tumors on pretreatment MRI
- Currently pregnant or breastfeeding
- Chemical abuse or dependence within the past six months
- Presence of metabolic conditions interfering with eating or digestion such as diabetes
- Body mass index (BMI) less than 13
AI-Screening
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Trial Site Locations
Total: 1 location
1
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
Research Team
N
Nir Lipsman, MD, PhD, FRCSC
CONTACT
A
Anusha Baskaran, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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