Condition: Anorexia Nervosa (DSM-IV Revised Criteria) · Sponsor: Sunnybrook Health Sciences Centre
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
This description comes directly from the study's public registry record.
Nir Lipsman, MD, PhD, FRCSC · 416-480-6954 · Nir.Lipsman@sunnybrook.ca
Anusha Baskaran, PhD · 416-480-6100 · anusha.baskaran@sunnybrook.ca
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| Sunnybrook Health Sciences Centre | Toronto, Ontario, Canada | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07113665