Background: Newer “closed-loop” neurostimulation devices in development could, in theory, induce changes to patients’ personalities and self-perceptions. Empirically, however, only limited data of patient and family experiences exist. Responsive neurostimulation (RNS) as a treatment for refractory epilepsy is the first approved and commercially available closed-loop brain stimulation system in clinical practice, presenting an opportunity to observe how conceptual neuroethical concerns manifest in clinical treatment. Methods: We conducted ethnographic research at a single academic medical center with an active RNS treatment program (...) and collected data via direct observation of clinic visits and in-depth interviews with 12 patients and their caregivers. We used deductive and inductive analyses to identify the relationship between these devices and patient changes in personality and self-perception. Results: Participants generally did not attribute changes in patients’ personalities or self-perception to implantation of or stimulation using RNS. They did report that RNS affected patients’ experiences and conceptions of illness. In particular, the capacity to store and display electrophysiological data produced a common frame of reference and a shared vocabulary among patients and clinicians .Discussion: Empirical experiences of a clinical population being treated with closed-loop neuromodulation do not corroborate theoretical concerns about RNS devices described by neuroethicists and technology developers. However, closed-loop devices demonstrated an ability to change illness experiences. Even without altering identify and self-perception, they provided new cultural tools and metaphors for conceiving of epilepsy as an illness and of the process of diagnosis and treatment. These findings call attention to the need to situate neuroethical concerns in the broader contexts of patients’ illness experiences and social circumstances. (shrink)

What happens at the end of a clinical trial for an investigational neural implant? It may be surprising to learn how difficult it is to answer this question. While new trials are initiated with increasing regularity, relatively little consensus exists on how best to conduct them, and even less on how to ethically end them. The landscape of recent neural implant trials demonstrates wide variability of what happens to research participants after an neural implant trial ends. Some former research participants (...) continue to receive support for their devices (e.g., battery and component replacements, software updates, etc.). Others, when safe, have their neural implants removed through surgical explantation. Still others continue to live with a deactivated neural implant embedded in their body. In the United States, there are no uniform requirements to provide services, of any kind, after an neural implant study ends, and other nations are similarly facing this challenge. The existence of a post-trial gap in an expanding neural implant research ecosystem invites obvious questions: What is owed to neural implant research participants post-trial, and why has providing it been so difficult to accomplish in practice? To take a step forward on this difficult issue, we assembled one group of stakeholders – researchers funded for neuroethics grants by the National Institutes of Health – to explore possible starting points on one topic: ethical guidance for post-trial care of research participants in neural implant trials. Based on shared concerns discussed in the expert workshop the current paper is a call to action. It reports the key areas of convergence from the meeting and highlights important next steps towards developing much needed guidance. (shrink)

Haeusermann et al. (Citation2023) draw three overall conclusions from their study on closed loop neuromodulation and self-perception in clinical treatment of refractory epilepsy. The first is that closed-loop neuromodulation devices did not substantially change epileptic patient’s personalities or self-perception postoperatively. The second is that some patients and caregivers attributed observed changes in personality and self-perception to the epilepsy itself and not to the DBS treatments. The third is that the devices provided participants with novel ways to make sense of their (...) illness. These findings further demonstrate a misalignment between some neuroethicists’ concerns about putative postoperative changes to personality, and the empirical evidence for such changes. Haeusermann et al. nonetheless concede that “neurotechnology directed at persisting rather than episodic clinical phenomena could have greater implications for personality or self-perception, either because they operate more continuously or are directed at clinical phenomena that are more stably integrated into patients’ self-concepts” (41). We acknowledge that the hypothesis that participants did not report changes because they were only episodically and not continually stimulated offers an interesting line for future investigation. Nonetheless, we would like to propose that potential postoperative personality changes might be correlated with the pathophysiology itself, rather than the stimulation effects of the technology. Generally, we advance the view that unintended effects solely induced by the technology cannot be excluded per se. Regardless, this comment aims to highlight that ethicists’ starting premise should be that patients suffering from diverse pathophysiology, or patients who are treated with stimulation in different brain regions and with differing parameters, would likely not react in the same way to treatment. (shrink)

Haeusermann et al. (2023) provide a valuable ethnographic window into how RNS device users understand themselves in relation to refractory epilepsy, the medications for it, and the use of the impla...

In their paper, “Closed-Loop Neuromodulation and Self-Perception in Clinical Treatment of Refractory Epilepsy,” Haeusermann et al. (2023) note that although responsive neurostimulation (RNS) data v...

Do neuromodulation technologies change patients’ personal identities? Haeusermann et al. claim that there is not enough evidence to support this worry. In their study, participants, following a res...