Abstract

Neurosurgical interventions for psychiatric disorders have a long and troubled history (1, 2) but have become much more refined in the last few decades due to the rapid development of neuroimaging and robotic technologies (2). These advances have enabled the design of less invasive techniques, which are more focused, such as deep brain stimulation (DBS) (3). DBS involves electrode insertion into specific neural targets implicated in pathological behavior, which are then repeatedly stimulated at adjustable frequencies. DBS has been used for Parkinson’s disease and movement disorders since the 1960s (4–6) and over the last decade has been applied to treatment-refractory psychiatric disorders, with some evidence of benefit in obsessive–compulsive disorder (OCD), major depressive disorder, and addictions (7). Recent consensus guidelines on best practice in psychiatric neurosurgery (8) stress, however, that DBS for psychiatric disorders remains at an experimental and exploratory stage. The ethics of DBS—in particular for psychiatric conditions—is debated (1, 8–10). Much of this discourse surrounds the philosophical implications of competence, authenticity, personality, or identity change following neurosurgical interventions, but there is a paucity of applied guidance on neuroethical best practice in psychiatric DBS, and health-care professionals have expressed that they require more (11). This paper aims to redress this balance by providing a practical, applied neuroethical gold standard framework to guide research ethics committees, researchers, and institutional sponsors. We will describe this as applied to our protocol for a particular research trial of DBS in severe and enduring anorexia nervosa (SE-AN) (https://clinicaltrials.gov/ct2/show/NCT01924598, unique identifier NCT01924598), but believe it may have wider application to DBS in other psychiatric disorders.

Highlights

  • Anorexia nervosa (AN) has the highest mortality rate of any psychiatric disorder and remains one of the most challenging psychiatric disorders to treat [12, 13]

  • The application of deep brain stimulation (DBS) to individuals with severe and enduring anorexia nervosa (SE-AN) raises particular ethical challenges [39,40,41,42,43], many of which are exacerbated by an invasive experimental intervention on the brain

  • We have presented an innovative neuroethical framework applied to DBS research in SE-AN to guide both research ethics committees and researchers in neurotechnologies applied to vulnerable psychiatric populations

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Summary

Introduction

Anorexia nervosa (AN) has the highest mortality rate of any psychiatric disorder and remains one of the most challenging psychiatric disorders to treat [12, 13]. Recent legal cases in the UK, and the successful use of guardianship orders in Australia, indicate that judges consider that patients with severe and enduring AN can lack mental capacity to make treatment decisions about their eating disorder, they are usually found at the same time to possess capacity to make other unrelated decisions. This raises serious questions about the mental capacity of these patients to consent to experimental treatment research into their eating disorder [47,48,49,50,51]

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