The Responsive Neurostimulation (RNS) system is a closed-loop system that continuously monitors electrical activity in specific brain regions via electrodes and administers stimulation at the detection of seizure related abnormalities. It is the only FDA approved closed-loop stimulation device and has been implanted in approximately 3000 patients since 2013. However, our ability to develop technology often occurs more quickly than our ability to consider the ramifications of these technologies. During our first seminar back from the winter break, epileptologists Vikram Rao and Manu Hegde presented a series of case studies from their experiences with the device in their clinics to frame our discussion on emerging novel ethical concerns of RNS for epilepsy.
Much of the discussion was focused on the RNS device’s production of patient electrographic data, raising questions about its intrinsic value and the best ways to manage such data in epilepsy care. Some issues included navigating between patient self-report of seizure activity and brain data recorded directly from the device. Continuous recordings of brain data can be therapeutic for patients to compare or receive validation of their own experiences with seizures, but it also raises questions about the obligations of clinicians who, due to their access to the data, might be expected to review it more frequently at the request of their patients or use the data as evidence for or against seizure activity, particularly as it concerns patients’ abilities to partake in activities like driving. Additionally, Vikram and Manu detailed patient perspectives about the device’s capabilities, noting that some misguidedly likened clinician access to recording and stimulation of the brain to mind reading and mind control, respectively. These anecdotes showed how the complexity of the device created unexpected and novel challenges to epilepsy care. The group noted the importance of being able to recognize and articulate these emerging dilemmas, and the need to develop ethical frameworks to guide care as the RNS device becomes more sophisticated and widespread.