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
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.
Duration of illness more than 10 years with no more than three months of remission in terms of weight;
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.
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)
Cerebrovascular disease (e.g. CVA within 6 months) or history of intracranial hemorrhage
Single group
ExAblate Neuro 4000
DeviceThe 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.
Safety and Feasibility of MRgFUS Capsulotomy in Patients with Treatment-Refractory Anorexia Nervosa
The frequency and severity of adverse events associated with ExAblate Transcranial Magnetic Resonance-guided Focused Ultrasound (MRgFUS) will be evaluated in patients with treatment-refractory anorexia nervosa and comorbid obsessive-compulsive disorder (OCD) and/or major depressive disorder (MDD). All adverse events-including procedure-related complications, neurological events, and other safety concerns-will be systematically documented, monitored, and assessed throughout the study duration.
Change in Body Mass Index Following MRgFUS Capsulotomy
Body Mass Index (BMI) will be used as an objective indicator of weight change and nutritional status. BMI will be calculated using weight (kg) divided by height (m²). Participants' BMI will be tracked over time to evaluate whether MRgFUS targeting the anterior limb of the internal capsule (ALIC) is associated with weight stabilization or improvement in individuals with treatment-refractory anorexia nervosa. Recommended BMI (Body Mass Index) for most adults is generally: Underweight: Below 18.5 Normal/Healthy weight: 18.5 - 24.9 Overweight: 25.0 - 29.9 Obese: 30.0 and above Notes: 1. The above mentioned ranges are from the World Health Organization (WHO) and are intended for adults 18-65 years old. 2. BMI is a quick screening tool but doesn't account for muscle mass, bone density, age or gender.
Change in Depressive Symptoms Using the Beck Depression Inventory
The Beck Depression Inventory (BDI) is a 21-item self-report inventory assessing the presence and severity of depressive symptoms. Each item is scored from 0 to 3, with a total score range of 0 to 63. Higher scores reflect more severe depressive symptoms.
Change in Anxiety Symptoms Using the Beck Anxiety Inventory
Evaluate the effectiveness of MR-guided Focused Ultrasound (MRgFUS) in reducing anxiety symptom severity using the Beck Anxiety Inventory (BAI), a validated patient-reported scale. Assessments will occur at baseline and at specified follow-up visits. The BAI consists of 21 items measuring common symptoms of anxiety experienced over the past week. Each item is rated on a scale from 0 (not at all) to 3 (severely). Total scores range from 0 to 63, with higher scores indicating more severe anxiety symptoms
Change in Quality of Life Using the Quality of Life Enjoyment and Satisfaction Questionnaire
The Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ-SF) is a 14-item self-report questionnaire evaluating life satisfaction across various domains (e.g., physical health, mood, work, social life). Items are scored from 1 (very poor) to 5 (very good) and converted to a percentage (0-100%).
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