69 Deep Brain Stimulation of the Ventral Anterior Limb of the Capsula Interna in Patients with Chronic Treatment-Refractory Anorexia Nervosa SUPPLEMENT 1. METHODS AND STATISTICAL ANALYSIS Methods Study Design and Patients In this first open-label pilot study, we report on the efficacy, feasibility and safety of bilateral vALIC DBS in chronic, treatment-refractory AN. The Medical Ethical Committee (MEC) of the Amsterdam University Medical Centers, location AMC (AUMC-AMC) approved this study, which we preregistered in the Netherlands Trial Register under trial number NL3322. A data safety monitoring board (DSMB) was installed. Inclusion Criteria • Clear primary diagnosis of AN (restricting or purging subtype) based on the Diagnostic and Statistical Manual for Mental Disorders version 4 (DSM-IV) (11), confirmed by psychiatric interview and review by an independent psychiatrist. • BMI < 15 • Illness duration of ≥10 years • Lack of response to ≥2 typical modes of treatment including ≥1 hospital admission and/or inpatient treatment in an eating disorder center. • Substantial functional impairment according to the DSM-IV criterion C and the Global Assessment of Function (GAF-score) of 45 or less for ≥2 years. Exclusion Criteria • Presence of unstable physical condition (severe electrolyte disturbances, cardiac failure, other physical contraindications for surgery/anesthesia) • Treatable underlying cause of anorexia/underweight • Inability to stop the use of anticoagulants, active neurological disease (like Parkinson’s disease, dementia, epilepsy) • Schizophrenia/history of psychosis • Bipolar disorder • Alcohol or substance abuse (including benzodiazepines) during the last 6 months • Current tic disorder • Antisocial personality disorder • Standard MRI scan exclusion criteria (e.g. pacemaker and metals contraindicated for MRI) Surgical procedure We conducted bilateral stereotactic implantation of quadripolar DBS electrodes (model 3389, Medtronic, Minneapolis), contact points being 1.5 mm long and separated from adjacent contacts by 0.5 mm, and an implantable neurostimulator under general anesthesia. Electrodes were
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