Advances in neuromodulation and an improved understanding of the anatomy and circuitry of psychopathology have led to a resurgence of interest in surgery for psychiatric disease. Clinical trials exploring deep brain stimulation (DBS), a focally targeted, adjustable and reversible form of neurosurgery, are being developed to address the use of this technology in highly selected patient populations. Psychiatric patients deemed eligible for surgical intervention, such as DBS, typically meet stringent inclusion criteria, including demonstrated severity, chronicity and a failure of conventional (...) therapy. Although a humanitarian device exemption by the US Food and Drug Administration exists for its use in obsessive-compulsive disorder, DBS remains a largely experimental treatment in the psychiatric context, with its use currently limited to clinical trials and investigative studies. The combination of a patient population at the limits of conventional therapy and a novel technology in a new indication poses interesting challenges to the informed consent process as it relates to clinical trial enrollment. These challenges can be divided into those that relate to the patient, their disease and the technology, with each illustrating how traditional conceptualisations of research consent may be inadequate in the surgical psychiatry context. With specific reference to risk analysis, patient autonomy, voluntariness and the duty of the clinician-researcher, this paper will discuss the unique challenges that clinical trials of surgery for refractory psychiatric disease present to the consent process. Recommendations are also made for an ethical approach to clinical trial consent acquisition in this unique patient population. (shrink)

Growing interest in psychiatric neurosurgery, and in deep brain stimulation (DBS) in particular, requires that the field be placed in the appropriate historical and scientific context. Current methods of neuromodulation for refractory psychiatric conditions are premised on assumptions similar to those proposed in earlier attempts, namely, the number of resistant patients and the absence of any other effective treatments. As a result, a discussion of the current and future prospects, as well as the limits, of neuromodulation is required to avoid (...) a replay of earlier transgressions, and to place its current chapter in the appropriate historical and ethical context. (shrink)

Growing interest in psychiatric neurosurgery, and in deep brain stimulation (DBS) in particular, requires that the field be placed in the appropriate historical and scientific context. Current methods of neuromodulation for refractory psychiatric conditions are premised on assumptions similar to those proposed in earlier attempts, namely, the number of resistant patients and the absence of any other effective treatments. As a result, a discussion of the current and future prospects, as well as the limits, of neuromodulation is required to avoid (...) a replay of earlier transgressions, and to place its current chapter in the appropriate historical and ethical context. (shrink)