52 Chapter 3 anxiety, restlessness, mood, obsessiveness, compulsiveness, avoidance, euphoria, impulsiveness and self-esteem. Statistical Analyses We analyzed data using Statistical Package for the Social Sciences (SPSS), version 26; IBM, Armonk, NY. We tabulated demographic and clinical characteristics using means and standard deviations for continuous variables. Linear mixed models analyzed changes between baseline and the 12-month follow-up, with repeated measurements being nested within patients. This study estimated a linear mixed model as the criterion and fixed effects of time (in phases) (on vs off) on subject specific slopes. We selected the covariance matrix using the corrected Akaike information criterion. Power analyses Given that this is the first study on vALIC DBS in AN, no formal a priori power calculations were conducted. The original target n was 6, in line with previous DBS studies (9, 10). During the course of the study, after the inclusion of 4 subjects, the new Medical Device Regulations (MDR) was implemented. Because the MDR was expected to cause delays in inclusion, in consultation with the DSMB and MEC, data of the 4 included subjects were deemed sufficient to answer the research questions and therefore further inclusion was considered redundant, thereby preventing any delays in the communication of these novel findings. RESULTS Patients’ demographics Four female patients with treatment-refractory anorexia nervosa were enrolled and underwent DBS of the vALIC between November 2016 and June 2020. Patients had a mean age of 39 years (SD=10) and average illness duration of 21 years (SD=3). Average baseline (T-1) BMI was 12.5 (SD=1.0) kg/m2, indicating extremely severe AN. All patients had a long and serious clinical history of treatment non-response, which included multiple hospital admissions for acute medical stabilization, medical treatment, in- and outpatient psychiatric treatment in specialized eating disorder centers and outpatient follow-up in the community. All patients suffered psychiatric comorbidities, including e.g. affective, obsessive-compulsive and personality disorders (table 1). Although the preoperative condition of the subjects was poor (low BMI and compromised physical status), no physical stabilization like refeeding was conducted. In three cases pre-operative supplementation of electrolytes was advised and given to minimize perioperative complications.
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