Deep brain stimulation research ethics: The ethical need for standardized reporting, adequate trial designs, and study registrations

Abstract

The applications of deep brain stimulation (DBS) are rapidly increasing and now include a large variety of neurological and psychiatric diseases, such as addiction, Alzheimer’s disease, anorexia nervosa, and rare movement disorders. High-quality data about benefit and harm of DBS in these disorders remain rare as many findings rely on small cohorts or single cases, variable methodologies, and differing outcome measures. Collectively, these problems make the field prone to bias and selective reporting, evoke ethical concerns regarding possibly premature expansions to new conditions without appropriate justification and research, and indicate the possibility that media, the public, and institutional review boards might be easily misguided by some reports. Thus, these problems are primarily not of scientific or methodological nature, but of ethical nature. Here, three approaches are suggested on how these problems might be reduced: by an optimization of trial designs, the implementation of standards of reporting, and the creation of a DBS study register which includes in particular single-case studies or case series. Future work has to work out these proposals in more detail and study its effectiveness when implemented in practice.