The ethical debate about neurotechnologies—including both drugs and implanted devices—has been largely framed around the questions of whether and when these technologies could damage or promote authenticity. Patients can experience changes in mood, behavior, emotion, or preferences—seemingly, changes in character or personality. Some describe such changes by saying they feel like different people; that they have become either more or less themselves; or that they feel as though some of their moods, behaviors, emotions or preferences are not their own. These (...) kinds of statements are used to describe both changes that a drug or device is... (shrink)

Deep brain stimulation is an invasive technique designed to stimulate certain deep brain regions for therapeutic purposes and is currently used mainly in patients with neurodegenerative disorders, such as Parkinson’s disease. However, DBS is also used increasingly for other experimental applications, such as the treatment of psychiatric disorders, weight reduction. Apart from its therapeutic potential, DBS can cause severe adverse effects, some that might also have a significant impact on the patient’s personality and autonomy by the external stimulation of DBS (...) which effects lie beyond the individual’s control and free will. The article’s purpose is to outline the procedures of DBS currently used in therapeutic and experimental applications and to discuss the ethical concerns regarding this procedure. It will address the clinical benefit-risk-ratio, the particular ethics of research in this field, and the ethical issues raised by affecting a patient’s or an individual’s personality and autonomous behaviour. Moreover, a potential ethical guideline, the Ulysses contract is discussed for the field of clinical application as well as the question of responsibility. (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)

Although philosophers have explored several connections between neuroscience and moral responsibility, the issue of how real-world neurological modifications, such as Deep Brain Stimulation, impact moral responsibility has received little attention. In this article, we draw on debates about the relevance of history and manipulation to moral responsibility to argue that certain kinds of neurological modification can diminish the responsibility of the agents so modified. We argue for a historicist position - a version of the history-sensitive reflection view - and defend (...) that account against a rival, relational view of responsibility. We conclude that DBS can, under certain conditions, diminish responsibility, and explore the circumstances under which this might be so. We conclude by suggesting that philosophical debates about moral responsibility, manipulation, and history have greater practical relevance than is sometimes thought, and that attention to practical cases can help inform and deepen this body of scholarship. (shrink)

Deep brain stimulation (DBS) is frequently described as a ‘reversible’ medical treatment, and the reversibility of DBS is often cited as an important reason for preferring it to brain lesioning procedures as a last resort treatment modality for patients suffering from treatment-refractory conditions. Despite its widespread acceptance, the claim that DBS is reversible has recently come under attack. Critics have pointed out that data are beginning to suggest that there can be non-stimulation-dependent effects of DBS. Furthermore, we lack long-term data (...) about other potential irreversible effects of neuromodulation. This has considerable normative implications for comparisons of DBS and brain lesioning procedures. Indeed, Devan Stahl and colleagues have recently argued that psychiatric DBS should be subject to the same legal safeguards as other forms of psychosurgery, supporting their position by forcibly criticising the claim that DBS is reversible. In this paper, I respond to these criticisms by first clarifying the descriptive and evaluative elements of the reversibility claim that supporters of DBS might invoke, and the different senses of ‘reversibility’ that we might employ in discussing the effects of medical procedures. I go on to suggest that it is possible to defend a nuanced version of the reversibility claim. To do so, I explain how DBS has some effects that are stimulation dependent in the short term, and argue that these effects can have significant normative implications for patient well-being and autonomy. I conclude that we should not abandon a nuanced version of the reversibility claim in the DBS debate. (shrink)

'Brainjacking’ refers to the exercise of unauthorized control of another’s electronic brain implant. Whilst the possibility of hacking a Brain–Computer Interface (BCI) has already been proven in both experimental and real-life settings, there is reason to believe that it will soon be possible to interfere with the software settings of the Implanted Pulse Generators (IPGs) that play a central role in Deep Brain Stimulation (DBS) systems. Whilst brainjacking raises ethical concerns pertaining to privacy and physical or psychological harm, we claim (...) that the possibility of brainjacking DBS raises particularly profound concerns about individual autonomy, since the possibility of hacking such devices raises the prospect of third parties exerting influence over the neural circuits underpinning the subject’s cognitive, emotional and motivational states. However, although it seems natural to assume that brainjacking represents a profound threat to individual autonomy, we suggest that the implications of brainjacking for individual autonomy are complicated by the fact that technologies targeted by brainjacking often serve to enhance certain aspects of the user’s autonomy. The difficulty of ascertaining the implications of brainjacking DBS for individual autonomy is exacerbated by the varied understandings of autonomy in the neuroethical and philosophical literature. In this paper, we seek to bring some conceptual clarity to this area by mapping out some of the prominent views concerning the different dimension of autonomous agency, and the implications of brainjacking DBS for each dimension. Drawing on three hypothetical case studies, we show that there could plausibly be some circumstances in which brainjacking could potentially be carried out in ways that could serve to enhance certain dimensions of the target’s autonomy. Our analysis raises further questions about the power, scope, and necessity of obtaining prior consent in seeking to protect patient autonomy when directly interfering with their neural states, in particular in the context of self-regulating closed-loop stimulation devices. (shrink)

Deep brain stimulation is an experimental procedure for treatment-resistant depression. Some results show promise, but blinded trials had limited success. Ethical questions center on vulnerability: especially on whether depressed patients can weigh the risks and benefits effectively, whether depression causes “desperation,” and whether media portrayals create unrealistic hopes. We interviewed 24 psychiatric inpatients with treatment-resistant depression, qualitatively analyzing their comments. Most had minimal interest in deep brain stimulators. Some might consider them if their depression worsened, if alternatives were exhausted, or (...) if the evidence were stronger. Fears focused on the surgery, adverse effects, and the novelty of the device. Patients felt the depression interfered with their ability to weigh the risks and benefits. Patients seemed highly attuned to the risks, and were skeptical that the treatment would be effective. We conclude that ethical concerns about vulnerability remain, yet patients with treatment-resistant depression were thoughtful and cautious about trying a novel therapy. (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)

Although being generally safe, the use of Deep Brain Stimulation has been associated with a significant number of patients experiencing postoperative psychological and neurological harm within experimental trials. A proportion of these postoperative severe adverse effects have lead to the decision to medically prescribe device deactivation or removal. However, there is little debate in the literature as to what is in the patient’s best interest when device removal has been prescribed; in particular, what should be the conceptual approach to ethically (...) guide the decision to remove or maintain implants. The purpose of this article is to examine the ethical issues raised when patients refuse brain device explantation despite medical prescription. In order to illustrate these issues, we report and discuss a clinical case involving a patient suffering from treatment resistant depression who experienced forms of postoperative self-estrangement, as well as suicidal attempts, but who resists giving consent to device explantation. (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)

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)

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)

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)

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)

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.

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

Optogenetics is being optimistically presented in contemporary media for its unprecedented capacity to control cell behavior through the application of light to genetically modified target cells. As such, optogenetics holds obvious potential for application in a new generation of invasive medical devices by which to potentially provide treatment for neurological and psychiatric conditions such as Parkinson's disease, addiction, schizophrenia, autism and depression. Design of a first-in-human optogenetics experimental trial has already begun for the treatment of blindness. Optogenetics trials involve a (...) combination of highly invasive genetic and electronic interventions that results in irreversible and permanent modifications of an individual's nervous system. Given its novelty, its uncertain benefit to patients, and its unique risk profile of irreversible physiological alteration, optogenetics requires a reassessment of the ethical challenges for protecting human participants in clinical trials, particularly at formative stages of clinical evaluation. This study explores the evolving ethical issues surrounding optogenetics’ potential harm to participants within trial design, especially focusing on whether Phase 1 trials should incorporate efficacy as well as safety endpoints in ways that are fair and respectful to research trial participants. (shrink)

Background: Psychiatric interventions are a contested area in medicine, not only because of their history of abuses, but also because their therapeutic goal is to affect emotions, thoughts, beliefs...

A number of reports have suggested that patients who undergo deep brain stimulation may experience changes to their personality or sense of self. These reports have attracted great philosophical interest. This paper surveys the philosophical literature on personal identity and DBS and draws on an emerging empirical literature on the experiences of patients who have undergone this therapy to argue that the existing philosophical discussion of DBS and personal identity frames the problem too narrowly. Much of the discussion by neuroethicists (...) centers on the nature of the threat posed by DBS, asking whether it is best understood as a threat to personal identity, autonomy, agency, or authenticity, or as putting patients at risk of self-estrangement. Our aim in this paper is to use the empirical literature on patients’ experiences post-DBS to open up a broader range of questions - both philosophical and practical, and to suggest that attention to these questions will help to provide better support to patients, both before and after treatment. (shrink)

Deep brain stimulation (DBS) uses electrodes implanted in the brain to modulate dysregulated brain activity related to a variety of neurological and psychiatric conditions. A number of people who use DBS have reported changes that affect their sense of self. In the neuroethics literature, there has been significant debate over the exact nature of these changes. More recently, there have been suggestions that this debate is overblown and detracts from clinically-relevant ways of understanding these effects of DBS. In this paper, (...) we offer an alternative approach to understanding the effects of DBS on the self, drawing on John Sadler’s work on self-illness ambiguity. We argue that self-illness ambiguity is a complex concept, with at least three different aspects, and that each of the three aspects we identify also characterizes one kind of DBS-related change. Our analysis also suggests ways of helping patients to adjust to life as a DBS user. (shrink)

Deep brain stimulation (DBS) uses electrodes implanted in the brain to modulate dysregulated brain activity related to a variety of neurological and psychiatric conditions. A number of people who use DBS have reported changes that affect their sense of self. In the neuroethics literature, there has been significant debate over the exact nature of these changes. More recently, there have been suggestions that this debate is overblown and detracts from clinically-relevant ways of understanding these effects of DBS. In this paper, (...) we offer an alternative approach to understanding the effects of DBS on the self, drawing on John Sadler’s work on self-illness ambiguity. We argue that self-illness ambiguity is a complex concept, with at least three different aspects, and that each of the three aspects we identify also characterizes one kind of DBS-related change. Our analysis also suggests ways of helping patients to adjust to life as a DBS user. (shrink)

Gilbert et al. argue that discussions of self-related changes in patients undergoing DBS are overblown. They show that there is little evidence that these changes occur frequently and make recommendations for further research. We point out that their framing of the issue, their methodology, and their recommendations do not attend to other important questions about these changes.

In this chapter, I propose the mechanism of cognitive enhancement based on studies of cognitive-enhancing drugs and behavioral training. I argue that there are mechanistic differences between cognitive-enhancing drugs and behavioral training due to their different enhancing effects. I also suggest possible mechanisms for cognitive-enhancing drugs and behavioral training and for the synergistic effects of their simultaneous application.