104 Chapter 5 METHODS Study design We conducted this study at the Department of Psychiatry and the Department of Neurosurgery of the Amsterdam UMC (Amsterdam University Medical Centers), location AMC (1). The Medical Ethical Committee (MEC) of the Amsterdam UMC, location AMC, approved the study (MEC number: 2012_169). We used an open label intervention clinical trial design. For the monetary reward task, we used a control group, whereas the food viewing task followed a within-subject design. Participants Patients were recruited from major clinics specialized in adult eating disorders in the Netherlands. We applied the following inclusion criteria: a clear primary diagnosis of AN (restricting or purging subtype) based on the DSM-IV, confirmed by a psychiatric interview conducted by an independent physician; illness duration of ≥10 years; and BMI <15. Additionally, patients must have shown no response to ≥2 typical modes of treatment, including one hospital admission or inpatient treatment in an eating disorder specialized clinic. They should also have exhibited substantial functional impairment according to the DSM-IV criterion C and a Global Assessment of Function-score (GAF-score) of ≤45 for ≥2 years. The exclusion criteria are described previously (1). This resulted in four female AN-patients who were enrolled from 2016 to 2020. Additionally, data from six healthy control subjects were included from previous (neuroimaging) projects of our department. The control subjects and their first-degree relatives had to have negative lifetime histories of psychiatric illness, as evaluated by SCID I and SCID II interviews. The controls were matched for sex (all female), but not for age (M=54; SD=4.7). The control subjects had no DBS-electrodes implanted and but were scanned at three different time-points. Procedure We conducted bilateral stereotactic implantation of DBS electrodes in the ventral anterior limb of the capsula interna (vALIC). Following our earlier DBS studies, we distinguished four sequential study phases: preoperative (T-1), surgery (T0), optimization (3–9 months; T1-T2) and maintenance (12 months; T2-T4). After screening at T-1, bilateral DBS electrodes were implanted in the vALIC at T0. We turned on and optimized DBS settings from T1 to T2, and followed patients up to T4. During the study, patients received standard medical and psychiatric care, which included regular visits with a nurse-practitioner and a psychiatrist. No major psychopharmacological adjustments were made.
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