Deep Brain Stimulation (DBS) is a neurosurgical procedure in which electrode(s) are implanted in the brain in order to target, measure, and modulate specific brain activities. Although most popularly used to treat movement disorders, DBS has gained traction for therapeutic use in neuropsychiatric illnesses and neuroenhancement. However, the technocratic development of DBS has largely ignored and/or been ignorant of non-clinical, non-quantitative information regarding how the device is used. Ethically, the design of DBS hardware, software, and procedural development should be informed by the ‘lived experiences’ of those who must live with the device daily, including those indirectly affected by DBS treatment, i.e. caregiver and family members, amongst others. This concern for end-user and end-user-affiliated perspectives in the ethical and technical development of DBS is further compounded in the following ways: (1) rising prevalence of DBS devices; (2) increasing use in disease-states necessitating caregiver interaction; (3) generally unidentified mechanisms of action; (4) concerns over unknown side-effects, particularly self-determination; (5) phasing out of the already scant, standardized qualitative information gleaned from patients by closed-loop developments; (6) device production by only two, U.S.-based companies; and (7) broad lack of FDA oversight.

As such, the goals of this project were two-fold: (a) determine the amount and type of qualitative research being collected on DBS; and (b) ascertain the content of non-clinical perspectives of DBS. A systematic literature review identified 505 publications and 22,452 participants in which qualitative data had been attained. Of those, only 86 (17%) studies and 5,179 (23%) fulfilled inclusion criteria related to non-clinical assessments and/or caregiver involvement with implications for DBS design. While such studies have developed since beginning DBS, numbers have remained relatively stagnant in the last 5 years. Qualitative studies of DBS for 32 illnesses were conducted in 36 countries, with only 24% of studies being conducted in the United States. Follow-up time ranged from pre-implantation to 16.6 years, yet 74% of follow-up information was garnered only up to 1 year. Finally, of all qualitative evaluations administered, only 9% were non-clinical assessments (i.e. leaving room for unique input), and only 1% involved input from caregivers. Full investigation of the implications of these results, as well as patient and caregiver narratives, are forthcoming.