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Introduction
Anorexia nervosa (AN) is an eating disorder characterised by pervasive preoccupations with body weight, shape and size. This translates into caloric restriction and/or excessive physical exercise to obtain and maintain a low body mass index (BMI). Pharmacotherapy has no sustained impact on weight or AN psychometrics. Conventional psychiatric treatment fails in about half, and 30%–50% of weight-restored patients relapse within a year.1 2
Since 2011, we have investigated deep brain stimulation (DBS) targeting the subcallosal cingulate (SCC) in patients with chronic, severe and highly refractory AN.3 4 We previously published 9-month outcomes in six patients3 and 1-year outcomes in 16 patients.4 We demonstrated short-term safety and acceptability of SCC–DBS and observed affective symptom improvements and cerebral glucose metabolism changes in key AN-related structures. Moreover, average BMI increased by 3.5 kg/m2 from baseline after 1-year of SCC–DBS.3 4
Given the invasive and experimental nature of SCC–DBS and the characteristic waxing and waning course of AN, we wished to report our long-term observations.
Patients and methods
This was a prospective long-term extension of a previously published open-label trial (ClinicalTrials.gov NCT01476540) conducted at the University of Toronto.3 4 Research Ethics Board approval (#10-0991-A) and informed consent were obtained. Inclusion and exclusion criteria, surgical details, adverse event classification and DBS programming algorithms have been described previously.3 4 In the current study, we exclusively analysed patients who had been stimulated for ≥3 years as of 1 October 2018. The primary outcome was procedure safety and acceptability. Secondary outcomes were long-term changes in BMI, eating behaviour, psychometrics (Hamilton Depression Rating Scale (HAMD), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Yale-Brown Obsessive Compulsive Scale (YBOCS), Yale-Brown-Cornell Eating Disorder Scale …
Footnotes
PDV and EL contributed equally.
Contributors PDV designed and conceptualised the study, analysed and interpreted all data, and drafted and submitted the manuscript. GJBE and AB played a major role in the acquisition of data and imaging analysis, and critically reviewed the manuscript. EL, KS, PG and DBW played a major role in the acquisition of the psychometric data and reviewed the manuscript. NL and AL designed and conceptualised the study, revised the manuscript and are responsible for the overall content as guarantors.
Funding This study was funded by the Klarman Family Foundation (2012 and 2013 one year awards to AML) and the Canadian Institutes of Health Research (2011 to 2014 CIHR fellowship to NL and AML).
Competing interests Dr. De Vloo has received grants from Research Fund-Flanders, the European Society for Stereotactic and Functional Neurosurgery, the Helaers Foundation, Medtronic, Boston Scientific, and St Jude-Abbott. Dr. Sutandar has received grants from the Klarman Family Foundation and the Canadian Institutes of Health Research. Dr. Lozano has received personal fees from Medtronic, Boston Scientific, St Jude-Abbott, and Functional Neuromodulation.
Provenance and peer review Not commissioned; internally peer reviewed.
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