Magnetic Resonance-Guided Focused Ultrasound Bilateral Capsulotomy for Refractory Anorexia Nervosa With Comorbid Obsessive Compulsive Disorder or Major Depressive Disorder

Korábbi kezelés

• 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

Más betegség

• 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).

Laborértékek

• 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.

Egyéb

• 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

• 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.