51 Deep Brain Stimulation of the Ventral Anterior Limb of the Capsula Interna in Patients with Chronic Treatment-Refractory Anorexia Nervosa the neurostimulation during three to six months. During this phase, we determined the stimulation parameter settings that provided the best clinical improvement (16). If, thereafter, we still expected clinical improvement with additional changes in neurostimulator settings, a continuation of the fine-tuning phase was possible for three more months (optimization was performed during three to nine months), with assessments of improvement every week until a plateau of effectiveness was reached. Patients entered the maintenance phase of the study after the optimization period was completed (T2). The maintenance phase consisted of a 12 months period with the stimulator on, to assess the long-term effect of DBS on BMI, comorbidity, and eating behavior. Measuring points during the maintenance phase were at 6 months (T3) and at 12 months (T4, end of the study). Outcome Measures Outcome measures can be categorized in physical, psychological, quality of life and safety. Primary physical outcome measure was the change in BMI. Primary psychological outcome measure was the YBC-EDS (19), scores ranging from 0 to 40; higher scores indicating more severe symptoms. The YBC-EDS assesses the nature and severity of preoccupations and rituals related to the subjects eating disorder comparable to the Yale Brown Obsessive-Compulsive Scale (YBOCS) for obsessive-compulsive disorder. Clinically relevant improvement was defined as a reduction of ≥35% on the YBC-EDS. Primary quality of life outcome measure was the ED-QOL (20), scores ranging from 0 to 100; higher scores indicating lower quality of life. Secondary psychological outcome measures included the Eating Disorder Inventory (EDI-II)(21), the Eating Disorder Examination Questionnaire (EDE-Q) (22), and the Eating Disorder Examination (EDE) (22). Secondary quality of life outcome measures included the Euroqol 6 Dimension (EQ-6D) (23), World Health Organization-Quality of Life (WHO-QOL-BREF) (24), the Medical Outcome Study Short Form (MOS-SF-36) (25), Sheenan Disability Scale (SDS) (26) and the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) (27). We established side effects and safety through frequent and intensive monitoring by a psychiatrist, including routine checks of vital parameters, standard clinical laboratory assessments and ECG. Additionally, at the main time-points of the study, we assessed all patients using (self-report) questionnaires: the South Oaks Gambling Screen (SOGS) (28) Symptom Check List (SCL-90) (29), Yale Brown Obsessive Compulsive Scale (YBOCS) (30), Fagerstrom Test for Nicotine Dependence (FTND) (31), Body Attitude Questionnaire (BAQ) (32), Rosenberg Self-esteem Scale (RSES) (33), Hamilton Depression Rating Scale (HAM-D) (34) and Hamilton Anxiety Rating Scale (HAM-A) (35). Furthermore, we took a six-question AN-symptom checklist comprising method of purging (laxatives, diuretics or self-induced vomiting), excessive exercise, binge-eating and amenorrhea. Answers were dichotomous (yes/no). Finally, a visual analog scale assessed emotions comprising
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