49 Deep Brain Stimulation of the Ventral Anterior Limb of the Capsula Interna in Patients with Chronic Treatment-Refractory Anorexia Nervosa 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 for DBS We recruited patients from major adult specialized eating disorder treatment centers in the Netherlands. Inclusion criteria included clear primary diagnosis of AN (restricting or purging subtype) based on the Diagnostic and Statistical Manual for Mental Disorders version 4 (DSM-IV) (17), confirmed by psychiatric interview and review by an independent psychiatrist. In order to include patients eligible for DBS as a last-resort treatment, we included patients with an illness duration of ≥10 years and a lack of response to ≥2 typical modes of treatment including ≥1 hospital admission and/or inpatient treatment in an eating disorder center. Furthermore, there had to be 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. The patients BMI had to be <15, classifying as extremely severe according to the DSM-5 (18). Exclusion Criteria Absolute contraindications for DBS were the 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, presence of unstable physical condition (severe electrolyte disturbances, cardiac failure, other physical contraindications for surgery/anesthesia), treatable underlying cause of anorexia/underweight and 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 implanted in the anterior limb of the internal capsule with an anterior angle of approximately 75° to the intercommissural line, using stereotactic frame-based 1.5 Tesla magnetic resonance imaging (MRI) coregistered to pre-operative 3T MRI with 1-mm slices for target determination. The upper three contact points of the electrode were placed in the vALIC, the lowest contact point was placed in the nucleus accumbens, ±3 mm anterior to the anterior commissure according to Mai et al., 2015.
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