As clinical trials end, little is understood about how participants exiting from clinical trials approach decisions related to the removal or post-trial use of investigational brain implants, such as deep brain stimulation (DBS) devices. This empirical bioethics study examines how research participants experience the process of exit from research at the end of clinical trials of implanted neural devices. Using a modified grounded theory study design, we conducted semi-structured, in-depth interviews with 16 former research participants from clinical trials of DBS (...) and responsive neurostimulation (RNS). Open-ended questions elicited motivations for joining the trial, understanding of study procedures at the time of initial informed consent, the process of exiting from research, and decisions about device removal or post-trial device use. Thematic analysis identified categories related to: limited preparedness for the end of research participation, straightforwardness of decisions to explant or keep the device, reconciling with the end of research participation, reconciling post-trial expectations, and achieving a sense of closure after exit from research. A preliminary theoretical model describes contextual factors influencing the process and experience of exit from research. Experiences of clinical trial participants should guide research practices to enhance the ethical design and conduct of clinical trials in DBS and other brain devices. (shrink)

Despite growing evidence that a significant number of patients living with Parkison’s disease experience neuropsychiatric changes following Deep Brain Stimulation treatment, the phenomenon remains poorly understood and largely unexplored in the literature. To shed new light on this phenomenon, we used qualitative methods grounded in phenomenology to conduct in-depth, semi-structured interviews with 17 patients living with Parkinson’s Disease who had undergone DBS. Our study found that patients appear to experience postoperative DBS-induced changes in the form of self-estrangement. Using the insights (...) from patients’ subjective perceptions of postoperative self-change provides a potent explanation of potential DBS-induced self-estrangement. (shrink)

Our think tank tasked by the Dutch Health Council, consisting of Radboud University Nijmegen Honours Academy students with various backgrounds, investigated the implications of Deep Brain Stimulation for psychiatric patients. During this investigation, a number of methodological, ethical and societal difficulties were identified. We consider these difficulties to be a reflection of a still fragmented field of research that can be overcome with improved organization and communication. To this effect, we suggest that it would be useful to found a centralized (...) DBS organization. Such an organization makes it possible to 1) set up and maintain a repository, 2) facilitate DBS studies with a larger sample size, 3) improve communication amongst researchers, clinicians and ethical committees, and 4) improve communication between DBS experts and the public at large. (shrink)

Deep brain stimulation (DBS) is an approved treatment for neurological diseases and a promising one for psychiatric conditions, which may produce spectacular results very quickly. It is also a powerful tool for brain research and exploration. Beyond an overview of the ethical and legal literature on this topic, this paper aims at showing that DBS is a compelling example for ethical-legal reflection, as it combines a highly technical surgical procedure, a complex active medical device and neuromodulation of the human brain (...) to restore lost abilities caused by a chronic and evolving disease. Some of the ethical and legal issues raised by DBS are not specific, but shed new light on medical ethics and law. Others are more DBS-specific, as they are linked to the intricacies of research and treatment, to the need to tune the device, to the patients’ control over the device and its effects and to the involvement of family caregivers. (shrink)

Owing to an oversight, we noted that the acknowledgement section was missing from the original published version of this paper.

While new generations of implantable brain computer interface devices are being developed, evidence in the literature about their impact on the patient experience is lagging. In this article, we address this knowledge gap by analysing data from the first-in-human clinical trial to study patients with implanted BCI advisory devices. We explored perceptions of self-change across six patients who volunteered to be implanted with artificially intelligent BCI devices. We used qualitative methodological tools grounded in phenomenology to conduct in-depth, semi-structured interviews. Results (...) show that, on the one hand, BCIs can positively increase a sense of the self and control; on the other hand, they can induce radical distress, feelings of loss of control, and a rupture of patient identity. We conclude by offering suggestions for the proactive creation of preparedness protocols specific to intelligent—predictive and advisory—BCI technologies essential to prevent potential iatrogenic harms. (shrink)

International institutions such as UNESCO are deliberating on a new standard setting instrument for neurotechnologies. This will likely lead to the adoption of a soft law document which will be the first global document specifically tailored to neurotechnologies, setting the tone for further international or domestic regulations. While some stakeholders have been consulted, these developments have so far evaded the broader attention of the neuroscience, neurotech, and neuroethics communities. To initiate a broader debate, this target article puts to discussion twenty-five (...) considerations and desiderata for recognition by a future instrument. They are formulated at different levels of abstraction, from the big picture to technical details, seek to widen the perspective of preparatory reports and transcend the narrow debate about “neurorights” which overshadows many richer and more relevant aspects. These desiderata are not an exhaustive enumeration but a starting point for discussions about what deserves and what requires protection by an international instrument. (shrink)

Deep brain stimulation (DBS) has been regarded as an efficient and safe treatment for Parkinson’s disease (PD) since being approved by the Food and Drug Administration (FDA) in 1997. It is estimated that more than 150 000 patients have been implanted, with a forecasted rapid increase in uptake with population ageing. Recent longitudinal follow-up studies have reported a significant increase in postoperative survival rates of patients with PD implanted with DBS as compared with those not implanted with DBS. Although DBS (...) tends to increase life expectancy for most patients with PD, this medical benefit does not come without attendant negative consequences. For example, emerging forms of iatrogenic harms are sometimes induced—harms which were not initially expected when clinicians proposed neurosurgery and patients or their guardians consented to the treatment. We report and discuss the clinical case of a patient who was implanted with DBS more than 20 years ago (at the time of writing) and is now experiencing unexpected stages of PD. This case illustrates how extending the life span without improving quality of life may introduce a burden of harms for patients and families. As well, this case shows why we should prepare for the expanding numbers of PD-implanted patients experiencing a gain of longevity but with severe stages of disease leading to diminution in quality of life. This newly observed effect of DBS treatment requires us to explore ethical questions related to iatrogenic harms, informed consent, end of life and caregivers’ burden. (shrink)

One important concern regarding implantable Brain Computer Interfaces is the fear that the intervention will negatively change a patient’s sense of identity or agency. In particular, there is concern that the user will be psychologically worse-off following treatment despite postoperative functional improvements. Clinical observations from similar implantable brain technologies, such as deep brain stimulation, show a small but significant proportion of patients report feelings of strangeness or difficulty adjusting to a new concept of themselves characterized by a maladaptive je ne (...) sais quoi despite clear motor improvement. Despite the growing number of cases in the DBS literature, there is currently no accepted or standardized tool in neuroethics specifically designed to capture the phenomenological postoperative experience of patients implanted with DBS or BCI devices. Given potential risks of postoperative maladaptation, it is important for the field of neuroethics to develop a qualitative instrument that can serve as a shared method for capturing postoperative variations in patient experience of identity and agency. The goal of this article is to introduce an instrument we have developed for this purpose and call for further neuroethical efforts to assess the phenomenology of implantable brain device use. (shrink)

The article Deflating the "DBS causes personality changes" bubble, written by Frederic Gilbert, J. N. M. Viaña and C. Ineichen, was originally published electronically on the publisher’s internet portal on 19 June 2018 without open access.

In this article, we explore how deep brain stimulation (DBS) devices designed to “close the loop”—to automatically adjust stimulation levels based on computational algorithms—may risk taking the individual agent “out of the loop” of control in areas where (at least apparent) conscious control is a hallmark of our agency. This is of particular concern in the area of psychiatric disorders, where closed-loop DBS is attracting increasing attention as a therapy. Using a relational model of identity and agency, we consider whether (...) DBS designed for psychiatric regulation may require special attention to agency. To do this, we draw on philosophical work on relational identity and agency, connecting it with reports from people using first-generation DBS devices for depression and obsessive-compulsive disorder. We suggest a way to extend a notion of relational agency to encompass neural devices. (shrink)

Recent developments of three-dimensional printing of biomaterials in medicine have been portrayed as demonstrating the potential to transform some medical treatments, including providing new responses to organ damage or organ failure. However, beyond the hype and before 3D bioprinted organs are ready to be transplanted into humans, several important ethical concerns and regulatory questions need to be addressed. This article starts by raising general ethical concerns associated with the use of bioprinting in medicine, then it focuses on more particular ethical (...) issues related to experimental testing on humans, and the lack of current international regulatory directives to guide these experiments. Accordingly, this article considers whether there is a limit as to what should be bioprinted in medicine; examines key risks of significant harm associated with testing 3D bioprinting for humans; investigates the clinical trial paradigm used to test 3D bioprinting; analyses ethical questions of irreversibility, loss of treatment opportunity and replicability; explores the current lack of a specific framework for the regulation and testing of 3D bioprinting treatments. (shrink)

In their article, Sankary et al. (2022) interviewed participants who underwent implantation (n = 16) and subsequent explantation (n = 9) of brain stimulation devices associated with their recent (n...

Using this case, Lavazza and Reichlin (2018) explored the ethical dilemmas associated with decision making in people with Alzheimer’s disease (AD), specifically when their new preferences conflict...

The idea that deep brain stimulation (DBS) induces changes to personality, identity, agency, authenticity, autonomy and self (PIAAAS) is so deeply entrenched within neuroethics discourses that it has become an unchallenged narrative. In this article, we critically assess evidence about putative effects of DBS on PIAAAS. We conducted a literature review of more than 1535 articles to investigate the prevalence of scientific evidence regarding these potential DBS-induced changes. While we observed an increase in the number of publications in theoretical neuroethics (...) that mention putative DBS-induced changes to patients’ postoperative PIAAAS, we found a critical lack of primary empirical studies corroborating these claims. Our findings strongly suggest that the theoretical neuroethics debate on putative effects of DBS relies on very limited empirical evidence and is, instead, reliant on unsubstantiated speculative assumptions probablyin lieuof robust evidence. As such, this may reflect the likelihood of a speculative neuroethics bubble that may need to be deflated. Nevertheless, despite the low number of first-hand primary studies and large number of marginal and single case reports, potential postoperative DBS changes experienced by patients remain a critical ethical concern. We recommend further empirical research in order to enhance theoretical neuroethics work in the area. In particular, we call for the development of better instruments capable of capturing potential postoperative variations of PIAAAS. (shrink)

The phenomenological effects of deep brain stimulation (DBS) on the self of the patient remains poorly understood and under described in the literature, despite growing evidence that a significant number of patients experience postoperative neuropsychiatric changes. To address this lack of phenomenological evidence, we conducted in-depth, semistructured interviews with 17 patients with Parkinson's disease who had undergone DBS. Exploring the subjective character specific to patients' experience of being implanted gives empirical and conceptual understanding of the potential phenomenon of DBS-induced self-estrangement. (...) Our study concluded that (1) the more patients preoperatively felt alienated by their illness, the more they experienced postoperative self-estrangement, and (2) the notion of self-estrangement seems to exist in association with certain common qualitative characters, namely, loss of control, which reflects a deteriorative estrangement, and distorted perception of capacities, which reveals a restorative estrangement. These findings indicate that subjective self-reports help us to understand some aspects of the potential phenomenon of DBS-induced self-estrangement. (shrink)

Our think tank tasked by the Dutch Health Council, consisting of Radboud University Nijmegen Honours Academy students with various backgrounds, investigated the implications of Deep Brain Stimulation for psychiatric patients. During this investigation, a number of methodological, ethical and societal difficulties were identified. We consider these difficulties to be a reflection of a still fragmented field of research that can be overcome with improved organization and communication. To this effect, we suggest that it would be useful to found a centralized (...) DBS organization. Such an organization makes it possible to 1) set up and maintain a repository, 2) facilitate DBS studies with a larger sample size, 3) improve communication amongst researchers, clinicians and ethical committees, and 4) improve communication between DBS experts and the public at large. (shrink)

BackgroundAs suggested by Shook and Giordano, understanding and therefore addressing the urgent international governance issues around globalizing bio-medical/technology research and applications is limited by the perception of the underlying science.MethodsA philosophical methodology is used, based on novel and classical philosophical reflection upon existent literature, clinical wisdoms and narrative theory to discover a meta-science and telos of humankind for the development of a relevant and defendable global biomedical bioethics.ResultsIn this article, through pondering an integrative systems approach, I propose a biomedical model (...) that may provide Western biomedicine with leadership and interesting insight into the unity beyond the artificial boundaries of its traditional divisions and the limit between physiological and pathological situations. A unified biomedicine, as scientific foundation, might then provide the basis for dissolution of similar reflected boundaries within bioethics. A principled and communitarian cosmopolitan bioethics may then be synonymous with a recently proposed principled and communitarian cosmopolitan neuroethics based on a novel objective meta-ethics. In an attempt to help facilitate equal and inclusive participation in inter-, multi-, and transdisciplinary intercultural discourse regarding the aforementioned international governance issues, I offer: a meta-science derived through considering the general behaviour of activity, plasticity and balance in biology and; a novel thought framework to encourage and enhance the ability for self-evaluation, self-criticism, and self-revision aimed at broadening perspective, as well as acknowledging and responding to the strengths and limitations of extant knowledge.ConclusionsThrough classical philosophical reflection, I evolve a theory of medicine to discover a telos of humankind which in turn provides an ‘internal’ moral grounding for a proposed global biomedical bioethics. (shrink)