Recruiting
Phase 1

MRgFUS Capsulotomy

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT07113665

Conditions

Anorexia Nervosa (DSM-IV Revised Criteria)

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

ExAblate Neuro 4000

Study Details

Brief 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

Conditions

Anorexia Nervosa (DSM-IV Revised Criteria)

Study ID

NCT07113665

Start date

Aug, 2025

Status verified date

Aug, 2025

Completion date

Aug, 2028

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Men and women ≥18 and ≤65 years of age, inclusive.
2. Patients who are competent and willing to give consent and able to attend study visits, as determined by both study Psychiatrist and the surgeon.
3. DSM-V diagnosis of Anorexia Nervosa, with co-morbid diagnosis of OCD and/or Major depressive disorder.
4. Treatment refractoriness indicated by any of:

1. Duration of illness more than 10 years with no more than three months of remission in terms of weight;
2. At least three attempts at expert hospital based treatment that were not successful or where there was no sustained response to treatment;
3. A pattern of increased medical instability requiring at least two episodes of emergency/involuntary re-feeding and lasting at least two years;
5. Ability to provide informed consent/competent to make medical decisions.

Exclusion Criteria:

1. Patients with unstable cardiac status \[e.g. Unstable angina pectoris on medication, Patients with documented myocardial infarction within six months, Congestive heart failure requiring medication (other than diuretic), Patients on anti-arrhythmic drugs, Severe hypertension (diastolic BP > 100 on medication)\]
2. Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations, etc.
3. 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)
4. Cerebrovascular disease (e.g. CVA within 6 months) or history of intracranial hemorrhage
5. Untreated, uncontrolled sleep apnea
6. 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
7. Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment
8. Are participating or have participated in another clinical trial in the last 30 days
9. Patients unable to communicate with the investigator and staff.
10. Presence of significant cognitive impairment
11. History of psychosis on clinical evaluation.
12. Patients with brain tumors already known or revealed on pretreatment MRI
13. Currently pregnant (as determined by history and serum HCG) or lactating.
14. Chemical abuse or dependence within the previous six months
15. Presence of a metabolic pathology interfering with eating or digestion (e.g. diabetes).
16. Body mass index (BMI) less than 13

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MR- guided Focused Ultrasound Capsulotomy

Participants in this arm will undergo a single MRI-guided focused ultrasound (MRgFUS) thermal ablation procedure targeting the anterior limb of the internal capsule (ALIC). The procedure is performed using the ExAblate 4000 MRgFUS system, with real-time MR thermometry to ensure precise lesioning.

This intervention is intended for individuals with treatment-refractory anorexia nervosa (AN) and comorbid obsessive-compulsive disorder (OCD) and/or major depressive disorder (MDD) who meet surgical eligibility criteria. All participants will complete standardized psychiatric and quality of life assessments at baseline and follow-up time points up to 24 months post-treatment to evaluate safety, feasibility, and preliminary clinical efficacy.

Interventions

ExAblate 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.

Primary outcome measure

  • Safety and Feasibility of MRgFUS Capsulotomy in Patients with Treatment-Refractory Anorexia Nervosa [ Time Frame: From day of treatment through 24 months post-treatment with evaluations at immediate post-op, 1, 3, 6, 12, 18 and 24 months. ]

Central Contacts and Locations

Central contacts

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Aug 14, 2025

Last verified

Aug, 2025

Keywords

  • Anorexia Nervosa
  • MR-guided Focused Ultrasound
  • bilateral capsulotomy
  • Obsessive Compulsive Disorder
  • Major Depressive Disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2025-08-14.