Deep Brain Stimulation: Ethical Issues in Clinical Practice and Neurosurgical Research

TLDR: In this paper, the authors focus on the various ethical issues related to the clinical application and research of deep brain stimulation, and apply the proper ethical frame against which to evaluate the risks and benefits of neuromodulation, and determine whether a procedure constitutes established therapy or remains investigational.

Abstract: Publisher Summary This chapter focuses on the various ethical issues related to the clinical application and research of deep brain stimulation. DBS is recognized as therapeutic for the management of chronic pain, the evaluation and management of epilepsy, and the treatment of Parkinson's disease and other movement disorders. The Food and Drug Administration (FDA) has also approved the use of the deep brain stimulator for refractory Parkinson's disease and essential tremor in 1997. Clinical investigators are conducting trials for its use in obsessive–compulsive disorders, which awaits FDA approval, depression, and traumatic brain injury. The boundary between experimental work and therapeutic deployment rests on FDA approval of the device and the consensus of the medical community that the putative treatment is effective and safe and that the intended beneficial outcome will appear without adverse long or short-term effects. To apply the proper ethical frame against which to evaluate the risks and benefits of neuromodulation, it is necessary to determine whether a procedure constitutes established therapy or remains investigational. Determining this distinction is critical or else the investigator or clinician can inadvertently mislead a potential research participant or patient about the safety and efficacy of an intervention. A therapeutic misconception can also have its origins in the hopes and desperation of a patient eager for cure or in the manner within which consent is obtained for enrollment in a clinical trial. Usually, these misperceptions stem from both a combination of hope and hype, which may or may not be intended on the part of the investigator.