ABSTRACT
The extensive postsurgical follow-up required with DBS makes it imperative that patients also have adequate emotional resources and social support. This is can be challenging for all patients, but is an area in which psychiatric patients may be especially vulnerable. Patients with obsessive compulsive disorder (OCD), for example, tend to exhibit lower social and emotional quality of life, especially patients who fail to respond to conventional treatments [20]. Social isolation is also common among patients with severe psychiatric illnesses such as major depressive disorder (MDD) [21].Current approaches for determining DBS eligibility seek to protect patients by ensuring that candidates have exhausted all other treatment options and have the personal resources necessary to do well following implantation. Following these criteria may result in denying the most vulnerable patients access to unproven, but potentially beneficial treatments such as DBS. Requiring that patients have exhausted all other treatment options may limit patient eligibility to those who have the financial and social resources to pursue those more conventional treatments. Combined with the costs of DBS surgery and postsurgical care, which have been estimated to be upwards of $80,000 per patient [22], the financial burden of DBS can be substantial. Questions about the proper allocation of medical resources will continue to be debated in the context of this financial burden.Use of DBS for psychiatric conditions is still experimental, and relatively few randomized control trials have been completed. The recent FDA approval of DBS for OCD under a Humanitarian Device Exemption (HDE) is intended for a condition that affects less than 4,000 individuals per year in the United States (21CFR814.100 [2014]). This has generated some controversy due to the possibility that the proportion of eligible candidates may be too high to warrant such an exemption [23]. The FDA has rejected that criticism, and a recent analysis by Garnaat and colleagues confirmed that a very small proportion of OCD patients (less than 1%) will meet criteria for neurosurgery [24]. Although it is unlikely that DBS is being over-used under a HDE, this debate highlights the reality that new and experimental applications of DBS may blur traditional boundaries between patient care and clinical research.
