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)

Discussion surrounding ethical and social issues in deep brain stimulation (DBS) has increased. This article introduces a special section on the ethics of DBS in The Journal of Clinical Ethics.

Gilles de la Tourette syndrome (TS) is a childhood neuropsychiatric disorder characterised by the presence of motor and vocal tics. Patients with malignant TS experience severe disease sequelae; risking morbidity and mortality due to tics, self-harm, psychiatric comorbidities and suicide. By definition, those cases termed ‘malignant’ are refractory to all conventional psychiatric and pharmacological regimens. In these instances, deep brain stimulation (DBS) may be efficacious. Current 2015 guidelines recommend a 6-month period absent of suicidal ideation before DBS is (...) offered to patients with TS. We therefore wondered whether it may be ethically justifiable to offer DBS to a minor with malignant TS. We begin with a discussion of non-maleficence and beneficence. New evidence suggests that suicide risk in young patients with TS has been underestimated. In turn, DBS may represent an invaluable opportunity for children with malignant TS to secure future safety, independence and fulfilment. Postponing treatment is associated with additional risks. Ultimately, we assert this unique risk-benefit calculus justifies offering DBS to paediatric patients with malignant TS. A multidisciplinary team of clinicians must determine whether DBS is in the best interest of their individual patients. We conclude with a suggestion for future TS-DBS guidelines regarding suicidal ideation. The importance of informed consent and assent is underscored. (shrink)

Davis called for “extreme caution” in the use of non-invasive brain stimulation to treat neurological disorders in children, due to gaps in scientific knowledge. We are sympathetic to his position. However, we must also address the ethical implications of applying this technology to minors. Compensatory trade-offs associated with NIBS present a challenge to its use in children, insofar as these trade-offs have the effect of limiting the child’s future options. The distinction between treatment and enhancement has some normative (...) force here. As the intervention moves away from being a treatment toward being an enhancement—and thus toward a more uncertain weighing of the benefits, risks, and costs—considerations of the child’s best interests diminish, and the need to protect the child’s autonomy looms larger. NIBS for enhancement involving trade-offs should therefore be delayed, if possible, until the child reaches a state of maturity and can make an informed, personal decision. NIBS for treatment, by contrast, is permissible insofar as it can be shown to be at least as safe and effective as currently approved treatments, which are themselves justified on a best interests standard. (shrink)

Deep brain stimulation (DBS) is optimistically portrayed in contemporary media. This already happened with psychosurgery during the first half of the twentieth century. The tendency of popular media to hype the benefits of DBS therapies, without equally highlighting risks, fosters public expectations also due to the lack of ethical analysis in the scientific literature. Media are not expected (and often not prepared) to raise the ethical issues which remain unaddressed by the scientific community. To obtain a more objective (...) portrayal of DBS in the media, a deeper collaboration between the science community and journalists, and particularly specialized ones, must be promoted. Access to databases and articles, directly or through science media centers, has also been proven effective in increasing the quality of reporting. This article has three main objectives. Firstly, to explore the past media coverage of leukotomy, and to examine its widespread acceptance and the neglect of ethical issues in its depiction. Secondly, to describe how current enthusiastic coverage of DBS causes excessive optimism and neglect of ethical issues in patients. Thirdly, to discuss communication models and strategies to enhance media and science responsibility. (shrink)

There is preliminary evidence, from case reports and investigational studies, to suggest that Deep Brain Stimulation could be used to treat some patients with Anorexia Nervosa. Although this research is at an early stage, the invasive nature of the intervention and the vulnerability of the potential patients are such that anticipatory ethical analysis is warranted. In this paper, we first show how different treatment mechanisms raise different philosophical and ethical questions. We distinguish three potential mechanisms alluded to in (...) the neuroscientific literature, relating to desire, control, and emotion, respectively. We explain why the precise nature of the mechanism has important implications for the patient’s autonomy and personal identity. In the second part of the paper, we consider practical dimensions of offering DBS to patients with AN in certain cases. We first discuss some limited circumstances where the mere offering of the intervention might be perceived as exerting a degree of coercive pressure that could serve to undermine the validity of the patient’s consent. Finally, we consider the implications of potential effects of DBS for the authenticity of the patient’s choice to continue using stimulation to ameliorate their condition. (shrink)

Case reports about patients undergoing Deep Brain Stimulation (DBS) for various motor and psychiatric disorders - including Parkinson’s Disease, Obsessive Compulsive Disorder, and Treatment Resistant Depression - have sparked a vast literature in neuroethics. Questions about whether and how DBS changes the self have been at the fore. The present chapter brings these neuroethical debates into conversation with recent research in moral psychology. We begin in Section 1 by reviewing the recent clinical literature on DBS. In Section 2, (...) we consider whether DBS poses a threat to personal identity. In Section 3 we argue for engagement with recent empirical work examining judgements of when identity changes. We conclude in Section 4 by highlighting a range of ethical issues raised by DBS, including various cross-cultural considerations. (shrink)

Deep brain stimulation (DBS) is a developing technology. New generations of DBS technology are already in the pipeline, yet this particular fact has been largely ignored among ethicists interested in DBS. Focusing only on ethical concerns raised by the current DBS technology is, albeit necessary, not sufficient. Since current bioethical concerns raised by a specific technology could be quite different from the concerns it will raise a couple of years ahead, an ethical analysis should be sensitive to such (...) alterations, or it could end up with results that soon become dated. The goal of this analysis is to address these changing bioethical concerns, to think ahead on upcoming and future DBS concerns both in terms of a changing technology and changing moral attitudes. By employing the distinction between inherent and noninherent bioethical concerns we identify and make explicit the particular limits and potentials for change within each category, respectively, including how present and upcoming bioethical concerns regarding DBS emerge and become obsolete. Many of the currently identified ethical problems with DBS, such as stimulation-induced mania, are a result of suboptimal technology. These challenges could be addressed by technical advances, while for instance perceptions of an altered body image caused by the mere awareness of having an implant may not. Other concerns will not emerge until the technology has become sophisticated enough for new uses to be realized, such as concerns on DBS for enhancement purposes. As a part of the present analysis, concerns regarding authenticity are used as an example. (shrink)

Deep brain stimulation has been of considerable interest to bioethicists, in large part because of the effects that the intervention can occasionally have on central features of the recipient’s personality. These effects raise questions regarding the philosophical concept of authenticity. In this article, we expand on our earlier work on the concept of authenticity in the context of deep brain stimulation by developing a diachronic, value-based account of authenticity. Our account draws on both existentialist and essentialist (...) approaches to authenticity, and Laura Waddell Ekstrom’s coherentist approach to personal autonomy. In developing our account, we respond to Sven Nyholm and Elizabeth O’Neill’s synchronic approach to authenticity, and explain how the diachronic approach we defend can have practical utility, contrary to Alexandre Erler and Tony Hope’s criticism of autonomy-based approaches to authenticity. Having drawn a distinction between the authenticity of an individual’s traits and the authenticity of that person’s values, we consider how our conception of authenticity applies to the context of anorexia nervosa in comparison to other prominent accounts of authenticity. We conclude with some reflections on the prudential value of authenticity, and by highlighting how the language of authenticity can be invoked to justify covert forms of paternalism that run contrary to the value of individuality that seems to be at the heart of authenticity. (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)

The success of deep brain stimulation (DBS) for movement disorders and the improved understanding of the neurobiologic and neuroanatomic bases of psychiatric diseases have led to proposals to expand current DBS applications. Recent preclinical and clinical work with Alzheimer's disease and obsessive-compulsive disorder, for example, supports the safety of stimulating regions in the hypothalamus and nucleus accumbens in humans. These regions are known to be involved in addiction and overeating associated with obesity. However, the use of DBS targeting (...) these areas as a treatment modality raises common ethical considerations, which include informed consent, coercion, enhancement, threat to personhood, and manipulation of the reward center. Pilot studies for both of these conditions are currently investigational. If these studies show promise, then there is a need to address the ethical concerns related to the initiation of clinical trials including the reliability of preclinical evidence, patient selection, study design, compensation for participation and injury, cost-effectiveness, and the need for long-term follow-up. Multidisciplinary teams are necessary for the ethical execution of such studies. In addition to establishing safety and efficacy, the consideration of these ethical issues is vital to the adoption of DBS as a treatment for these conditions. We offer suggestions about the pursuit of future clinical trials of DBS for the treatment of addiction and overeating associated with obesity and provide a framework for addressing ethical concerns related to treatment. (shrink)

Ethical evaluation of deep brain stimulation as a treatment for Parkinson’s disease is complicated by results that can be described as involving changes in the patient’s identity. The risk of becoming another person following surgery is alarming for patients, caregivers and clinicians alike. It is one of the most urgent conceptual and ethical problems facing deep brain stimulation in Parkinson’s disease at this time. In our paper we take issue with this problem on two accounts. First, (...) we elucidate what is meant by “becoming another person” from a conceptual point of view. After critically discussing two broad approaches we concentrate on the notion of “individual identity” which centers on the idea of “core attitudes”. Subsequently we discuss several approaches to determine what distinguishes core attitudes from those that are more peripheral. We argue for a “foundational-function model” highlighting the importance of specific dependency relations between these attitudes. Our second aim is to comment on the possibility to empirically measure changes in individual identity and argue that many of the instruments now commonly used in selecting and monitoring DBS-patients are inappropriate for this purpose. Future research in this area is advised combining a conceptual and an empirical approach as a basis of sound ethical appraisal. (shrink)

This paper explores the impacts of neurological intervention on selfhood with reference to recipients’ claims about changes to their self-understanding following Deep Brain Stimulation for treatment of Parkinson’s Disease. In the neuroethics literature, patients’ claims such as: “I don’t feel like myself anymore” and “I feel like a machine”, are often understood as expressing threats to identity. In this paper I argue that framing debates in terms of a possible threat to identity—whether for or against the proposition, is (...) mistaken and occludes what is ethically salient in changes from DBS. Rather, by adopting a relational narrative approach to identity and autonomy, I show that the ethically salient issue from DBS is impacts on autonomous agency—whether one’s actions and beliefs are one’s own, and how DBS may hinder, or foster, embodied, relational autonomy competences. This approach recognizes that if sufficiently significant, impacts on autonomy competences may pose a threat to one’s ability to contribute to the process of authoring one’s own life and so pose a threat to identity formation. I argue this approach resolves the confusion in the literature about whether and how DBS threatens identity and provides a complex picture of how DBS may affect selfhood by disrupting narrative identity formation and revision, distorting agency and/or undermining autonomy. (shrink)

Although an invasive medical intervention, Deep Brain Stimulation (DBS) has been regarded as an efficient and safe treatment of Parkinson’s disease for the last 20 years. In terms of clinical ethics, it is worth asking whether the use of DBS may have unanticipated negative effects similar to those associated with other types of psychosurgery. Clinical studies of epileptic patients who have undergone an anterior temporal lobectomy have identified a range of side effects and complications in a number (...) of domains: psychological, behavioural, affective and social. In many cases, patients express difficulty adjusting from being chronically ill to their new status as ‘treated’ or ‘seizure free’. This postoperative response adjustment has been described in the literature on epilepsy as the ‘Burden of Normality’ (BoN) syndrome. Most of the discussion about DBS postoperative changes to self is focused on abnormal side effects caused by the intervention (ie, hypersexuality, hypomania, etc). By contrast, relatively little attention is paid to the idea that successfully ‘treated’ individuals might experience difficulties in adjusting to becoming ‘normal’. The purpose of this paper is (1) to articulate the postoperative DBS psychosocial adjustment process in terms of the BoN syndrome, (2) to address whether the BoN syndrome illustrates that DBS treatment poses a threat to the patient’s identity, and (3) to examine whether the current framework for rehabilitation after DBS procedures should be updated and take into account the BoN syndrome as a postoperative self-change response. (shrink)

One of the topics that often comes up in ethical discussions of deep brain stimulation (DBS) is the question of what impact DBS has, or might have, on the patient’s self. This is often understood as a question of whether DBS poses a “threat” to personal identity, which is typically understood as having to do with psychological and/or narrative continuity over time. In this article, we argue that the discussion of whether DBS is a “threat” to continuity over (...) time is too narrow. There are other questions concerning DBS and the self that are overlooked in discussions exclusively focusing on psychological and/or narrative continuity. For example, it is also important to investigate whether DBS might sometimes have a positive (e.g. a rehabilitating) effect on the patient’s self. To widen the discussion of DBS, so as to make it encompass a broader range of considerations that bear on DBS’s impact on the self, we identify six features of the commonly used concept of a person’s “true self”. We apply these six features to the relation between DBS and the self. And we end with a brief discussion of the role DBS might play in treating otherwise treatment-refractory anorexia nervosa. This further highlights the importance of discussing both continuity over time and the notion of the true self. (shrink)

Questions about the nature of self and self-consciousness are closely aligned with questions about the nature of autonomy. These concepts have deep roots in traditional philosophical discussions that concern metaphysics, epistemology and ethics. They also have direct relevance to practical considerations about informed consent in medical contexts. In this paper, with reference to understanding specific side effects of deep brain stimulation treatment in cases of, for example, Parkinson’s Disease, Obsessive Compulsive Disorder, and Major Depressive Disorder, I’ll argue (...) that it is best to frame discussions of informed consent in terms of relational autonomy and a pattern theory of self. (shrink)

Introduction Tourette Syndrome is a childhood onset disorder characterized by vocal and motor tics and often remits spontaneously during adolescence. For treatment refractory patients, Deep Brain Stimulation may be considered. Methods and Results We discuss ethical problems encountered in two adolescent TS patients treated with DBS and systematically review the literature on the topic. Following surgery one patient experienced side effects without sufficient therapeutic effects and the stimulator was turned off. After a second series of behavioural treatment, he (...) experienced a tic reduction of more than 50%. The second patient went through a period of behavioural disturbances that interfered with optimal programming, but eventually experienced a 70% tic reduction. Sixteen DBS surgeries in adolescent TS patients have been reported, none of which pays attention to ethical aspects. Discussion Specific ethical issues arise in adolescent TS patients undergoing DBS relating both to clinical practice as well as to research. Attention should be paid to selecting patients fairly, thorough examination and weighing of risks and benefits, protecting the health of children and adolescents receiving DBS, special issues concerning patient’s autonomy, and the normative impact of quality of life. In research, registration of all TS cases in a central database covering a range of standardized information will facilitate further development of DBS for this indication. Conclusion Clinical practice should be accompanied by ongoing ethical reflection, preferably covering not only theoretical thought but providing also insights in the views and perspectives of those concerned, that is patients, family members and professionals. (shrink)

Deep brain stimulation interventions are novel devices being investigated for the management of severe treatment-resistant psychiatric illnesses. These interventions require the invasive implantation of high-frequency neurostimulatory probes intracranially aiming to provide symptom relief in treatment-resistant disorders including obsessive-compulsive disorder and anorexia nervosa. In the scientific literature, these neurostimulatory interventions are commonly described as reversible and to be used as a last resort option for psychiatric patients. However, the ‘last resort’ status of these interventions is rarely expanded upon. Contrastingly, (...) usages of DBS devices for neurological symptoms have paved the way for established safety and efficacy standards when used earlier in a disease’s timeline. As DBS treatments for these neurological diseases progress to have earlier indications, there is a parallel ethical concern that early implementation may one day become prescribed for psychiatric illnesses. The purpose of this article is to build off contemporary understandings of reversible neurostimulatory interventions to examine and provide clarifications on the ‘last resort’ status of DBS to better address its ethically charged use in psychiatric neurosurgery. To do this, evaluative differences between DBS treatments will be discussed to demonstrate how patient autonomy would be a paramount guiding principle when one day implementing these devices at various points along a psychiatric disease’s timeline. In presenting the clarification of ‘last resort’ status, the ethical tensions of early DBS interventions will be better understood to assist in providing psychiatric patients with more quality of life years in line with their values. (shrink)

Dystonia is a movement disorder that can have a debilitating impact on motor functions and quality of life. There are 250,000 cases in the United States, most with childhood onset. Due to the limited effectiveness and side effects of available treatments, pediatric deep brain stimulation has emerged as an intervention for refractory dystonia. However, there is limited clinical and neuroethics research in this area of clinical practice. This paper examines whether it is ethically justified to offer pDBS to (...) children with refractory dystonia. Given the favorable risk-benefit profile, it is concluded that offering pDBS is ethically justified for certain etiologies of dystonia, but it is less clear for others. In addition, various ethical and policy concerns are discussed, which need to be addressed to optimize the practice of offering pDBS for dystonia. Strategies are proposed to help address these concerns as pDBS continues to expand. (shrink)

The goal of this article is to shed light on Deep Brain Stimulation (DBS) postoperative suicidality risk factors within Treatment Resistant Depression (TRD) patients, in particular by focusing on the ethical concern of enrolling patient with history of self-estrangement, suicide attempts and impulsive–aggressive inclinations. In order to illustrate these ethical issues we report and review a clinical case associated with postoperative feelings of self-estrangement, self-harm behaviours and suicide attempt leading to the removal of DBS devices. Could prospectively identifying (...) and excluding patients with suicidality risk factors from DBS experimental trials—such as history of self-estrangement, suicide attempts and impulsive–aggressive inclinations—lead to minimizing the risk of suicidality harm? (shrink)

In this paper, we engage in dialogue with Jonathan Pugh, Hannah Maslen, and Julian Savulescu about how to best interpret the potential impacts of deep brain stimulation on the self. We consider whether ordinary people’s convictions about the true self should be interpreted in essentialist or existentialist ways. Like Pugh et al., we argue that it is useful to understand the notion of the true self as having both essentialist and existentialist components. We also consider two ideas from (...) existentialist philosophy – Jean-Paul Sartre and Simone de Beauvoir’s ideas about “bad faith” and “ambiguity” – to argue that there can be value to patients in regarding themselves as having a certain amount of freedom to choose what aspects of themselves should be considered representative of their true selves. Lastly, we consider the case of an anorexia nervosa-patient who shifts between conflicting mind-sets. We argue that mind-sets in which it is easier for the patient and his or her family to share values can plausibly be considered to be more representative of the patient’s true self, if this promotes a well-functioning relationship between the patient and the family. However, we also argue that families are well-advised to give patients room to figure out what such shared values mean to them, since it can be alienating for patients if they feel that others try to impose values on them from the outside. (shrink)

Background -/- Innovative neurosurgical treatments present a number of known risks, the natures and probabilities of which can be adequately communicated to patients via the standard procedures governing obtaining informed consent. However, due to their novelty, these treatments also come with unknown risks, which require an augmented approach to obtaining informed consent. -/- Objective -/- This paper aims to discuss and provide concrete procedural guidance on the ethical issues raised by serious unexpected complications of novel deep brain stimulation (...) treatments. -/- Approach -/- We illustrate our analysis using a case study of the unexpected development of recurrent stereotyped events in patients following the use of deep brain stimulation (DBS) to treat severe chronic pain. Examining these unexpected complications in light of medical ethical principles, we argue that serious complications of novel DBS treatments do not necessarily make it unethical to offer the intervention to eligible patients. However, the difficulty the clinician faces in determining whether the intervention is in the patient's best interests generates reasons to take extra steps to promote the autonomous decision making of these patients. -/- Conclusion and recommendations -/- We conclude with clinical recommendations, including details of an augmented consent process for novel DBS treatment. (shrink)

This paper discusses the use of deep brain stimulation for the treatment of neurological and psychiatric disorders in children. At present, deep brain stimulation is used to treat movement disorders in children and a few cases of deep brain stimulation for psychiatric disorders in adolescents have been reported. Ethical guidelines on the use of deep brain stimulation in children are therefore urgently needed. This paper focuses on the decision-making process, and provides an (...) ethical framework for (future) treatment decisions in pediatric deep brain stimulation. I defend a shared decision-making model in case of deep brain stimulation for neurological and psychiatric disorders in children. To protect the vulnerable child patient, a dual consent process is needed where parents or parental guardians give their consent, and the child gives his/her assent. (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)

Introduction As deep brain stimulation (DBS) has shifted to being used earlier during Parkinson’s disease (PD), data is lacking regarding patient specific attitudes, preferences, and factors which may influence the timing of and decision to proceed with DBS in the United States. This study aims to identify and compare attitudes and preferences regarding the earlier use of DBS in Parkinson’s patients who have and have not undergone DBS. Methods We developed an online survey concerning attitudes about DBS and (...) its timing in PD. The survey was distributed nationally in the United States via the Michael J. Fox Foundation Trial Finder, the American Parkinson Disease Association flyers, and as a link on the Parkinson Alliance website. Differences in responses between PD DBS and non-DBS patients were assessed. Results A total of 445 patients with PD met eligibility criteria for the survey of which 160 self-identified as having undergone DBS. Fifty-five percent (n = 124) of non-DBS patients believed that DBS for PD should only be considered after all medication options have been tried. Patients favoring early DBS had fewer concerns regarding the surgery than those favoring later DBS. Conclusion Our findings highlight a variety of important considerations and concerns patients have regarding DBS and its timing. These viewpoints are important aspects of shared decision-making, as they help to identify patients’ preferences, values, and goals, which should enable providers to better navigate, with their patients, the decision path for therapeutic options to consider. (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)

Deep brain stimulation (DBS) has been proposed as a potential treatment of drug addiction on the basis of its effects on drug self-administration in animals and on addictive behaviours in some humans treated with DBS for other psychiatric or neurological conditions. DBS is seen as a more reversible intervention than ablative neurosurgery but it is nonetheless a treatment that carries significant risks. A review of preclinical and clinical evidence for the use of DBS to treat addiction suggests that (...) more animal research is required to establish the safety and efficacy of the technology and to identify optimal treatment parameters before investigating its use in addicted persons. Severely addicted persons who try and fail to achieve abstinence may, however, be desperate enough to undergo such an invasive treatment if they believe that it will cure their addiction. History shows that the desperation for a cure of addiction can lead to the use of risky medical procedures before they have been rigorously tested. In the event that DBS is used in the treatment of addiction, we provide minimum ethical requirements for clinical trials of its use in the treatment of addiction. These include: restrictions of trials to severely intractable cases of addiction; independent oversight to ensure that patients have the capacity to consent and give that consent on the basis of a realistic appreciation of the potential benefits and risks of DBS; and rigorous assessments of the effectiveness and safety of this treatment compared to the best available treatments for addiction. (shrink)

Deep brain stimulation has been regarded as an efficient and safe treatment for Parkinson’s disease since being approved by the Food and Drug Administration 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 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)

Patient narratives from two investigational deep brain stimulation trials for traumatic brain injury and obsessive‐compulsive disorder reveal that injury and illness rob individuals of personal identity and that neuromodulation can restore it. The early success of these interventions makes a compelling case for continued post‐trial access to these technologies. Given the centrality of personal identity to respect for persons, a failure to provide continued access can be understood to represent a metaphorical identity theft. Such a loss recapitulates (...) the pain of an individual's initial injury or illness and becomes especially tragic because it could be prevented by robust policy. A failure to fulfill this normative obligation constitutes a breach of disability law, which would view post‐trial access as a means to achieve social reintegration through this neurotechnological accommodation. (shrink)

In this article, I explore select case studies of Parkinson patients treated with deep brain stimulation in light of the notions of alienation and authenticity. While the literature on DBS has so far neglected the issues of authenticity and alienation, I argue that interpreting these cases in terms of these concepts raises new issues for not only the philosophical discussion of neuro-ethics of DBS, but also for the psychological and medical approach to patients under DBS. In particular, (...) I suggest that the experience of alienation and authenticity varies from patient to patient with DBS. For some, alienation can be brought about by neurointerventions because patients no longer feel like themselves. But, on the other hand, it seems alienation can also be cured by DBS as other patients experience their state of mind as authentic under treatment and retrospectively regard their former lives without stimulation as alienated. I argue that we must do further research on the relevance of authenticity and alienation to patients treated with DBS in order to gain a deeper philosophical understanding, and to develop the best evaluative criterion for the behavior of DBS patients. (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)

In the following text, medical, anthropological and ethical issues of deep brain stimulation, a medical technology in which electrodes implanted in the human brain electrically influence specified brain regions, will be discussed. After a brief account of the deep brain stimulation procedure and its chances and risks, anthropological and ethical aspects of the approach will be discussed. These relate to the reversibility of the procedure and to the patient’s capacity to control the effects it (...) exerts in the brain, to modifications and fluctuations in a person’s character traits and individuality brought about by neurostimulation, and to the range of legitimate, adequate uses of the deep brain stimulation approach. The paper concludes that deep brain stimulation should be confined to therapeutic contexts and to severe, otherwise treatment-refractory disorders in which the aim is to normalize brain functioning. Apart from this, it should not be used to modify a person’s individual character traits and behaviour or to enhance human traits. (shrink)

This contribution aims at describing the experiences of Deep Brain Stimulation (DBS) as discussed on Internet forums. Since the 2000s, increasing attention has been paid to health practices associated with the use of the Internet, whether by medical professionals, public authorities or researchers in the social sciences. We know that Internet is used by patients with Parkinson’s disease, in order to discuss about their lived experiences. This contribution will present how these Internet users address the specific theme of (...) DBS. We will examine how their use and the information sharing associated to it participate in the “shaping” of the lived experience of deep cerebral stimulation. This contribution will be introduced by an analysis of the state-of-the-art in sociological and anthropological international research on the topic of “Internet health”. On the basis of this analysis, it will propose a framework to describe and understand the various uses of the web that are made to give an account of the experience of stimulation. The existence of collective mobilizations in Parkinson’s disease, an old Internet experience and media oppositions concerning certain antiparkinsonian drugs, are conditions which push us to question these themes concerning DBS. This paper is a description, for the first time, of roles played by the users of these Internet forums and the different online activities produced about DBS subject. In an ethnographic perspective, we had to imagine that we were an Internet user seeking patient experiences with this surgical procedure to understand these interactions about DBS. The main goal of this contribution is to describe the attention paid by users for medical information about DBS in the identity and self-help process. The interest of such an approach is to open an anthropological reflection on the place and the role of the medical representations in the testimonies of experience of the disease or the treatments. (shrink)

According to a prominent suggestion in the ethics of transcranial neurostimulation the effects of such devices can be treated as ethically on par with established, pre-neurotechnological alterations of the mind. This parity allegedly is supported by situated cognition theories showing how external devices can be part of a cognitive system. This article will evaluate this suggestion. It will reject the claim, that situated cognition theories support ethical parity. It will however point out another reason, why external carriers or modifications (...) of the mental might come to be considered ethically on par with internal carriers. Section “Why Could There Be Ethical Parity between Neural Tissue and External Tools?” presents the ethical parity theses between external and internal carriers of the mind as well as neurotechnological alterations and established alterations. Section “Extended, Embodied, Embedded: Situated Cognition as a Relational Thesis” will elaborate the different situated cognition approaches and their relevance for ethics. It will evaluate, whether transcranial stimulation technologies are plausible candidates for situated cognition theses. Section “On the Ethical Relevance of Situated Cognition Theses” will discuss criteria for evaluating whether a cognitive tool is deeply embedded with a cognitive system and apply these criteria to transcranial brain stimulation technologies. Finally it will discuss the role diverse versions of situated cognition theory can play in the ethics of altering mental states, especially the ethics of transcranial brain stimulation technologies. (shrink)

The United States Food and Drug Administration's recent approval of the commercial use of Deep Brain Stimulation (DBS) as a treatment for Obsessive Compulsive Disorder (OCD) will be discussed within the context of the existing USA regulatory framework. The purpose will be to illustrate the current lack of regulation and oversight of the DBS market, which has resulted in the violation of basic ethical norms. The discussion will focus on: 1) the lack of available evidence on procedural safety (...) and efficacy, 2) the numerous conflicts of interest held by research investigators, and 3) the ambiguity of both aforementioned categories due to an inherent lack of transparency in the research. It is argued that in order to address these issues, ethical analyses of DBS for psychiatric disorders must include the role of the industry forces that have become the primary impetus for this research. As such, DBS for OCD serves as an important case example in studies of neurotechnology and innovative surgery. (shrink)

We estimate that 208,000 deep brain stimulation (DBS) devices have been implanted to address neurological and neuropsychiatric disorders worldwide. DBS Think Tank presenters pooled data and determined that DBS expanded in its scope and has been applied to multiple brain disorders in an effort to modulate neural circuitry. The DBS Think Tank was founded in 2012 providing a space where clinicians, engineers, researchers from industry and academia discuss current and emerging DBS technologies and logistical and ethical issues (...) facing the field. The emphasis is on cutting edge research and collaboration aimed to advance the DBS field. The Eighth Annual DBS Think Tank was held virtually on September 1 and 2, 2020 (Zoom Video Communications) due to restrictions related to the COVID-19 pandemic. The meeting focused on advances in: (1) optogenetics as a tool for comprehending neurobiology of diseases and on optogenetically-inspired DBS, (2) cutting edge of emerging DBS technologies, (3) ethical issues affecting DBS research and access to care, (4) neuromodulatory approaches for depression, (5) advancing novel hardware, software and imaging methodologies, (6) use of neurophysiological signals in adaptive neurostimulation, and (7) use of more advanced technologies to improve DBS clinical outcomes. There were 178 attendees who participated in a DBS Think Tank survey, which revealed the expansion of DBS into several indications such as obesity, post-traumatic stress disorder, addiction and Alzheimer’s disease. This proceedings summarizes the advances discussed at the Eighth Annual DBS Think Tank. (shrink)

While research to improve memory or counter decay caused by neurodegenerative diseases has a fairly long history, scientific attempts to erase memories are very recent. The use of non-invasive brain stimulation for memory modulation represents a new and promising application for the treatment of certain disorders [such as Post-Traumatic Stress Disorder ]. However, numerous ethical issues are related to memory intervention. In particular, the possibility of using forms of non-invasive brain stimulation requires to distinguish treatment interventions (...) from the enhancement of the healthy. Furthermore, a range of important societal and legal concerns arise when manipulating memories. In this short contribution, we address some of the most significant ethical, social, and legal implications surrounding the application of memory-modulation techniques and offer a series of reflections and considerations, which we hope can be of use to guide -and perhaps regulate- their potential, future implementation in society. (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 is currently being investigated as an experimental treatment for patients suffering from treatment-refractory AN, with an increasing number of case reports and small-scale trials published. Although still at an exploratory and experimental stage, initial results have been promising. Despite the risks associated with an invasive neurosurgical procedure and the long-term implantation of a foreign body, DBS has a number of advantageous features for patients with SE-AN. Stimulation can be fine-tuned to the specific needs of (...) the particular patient, is relatively reversible, and the technique also allows for the crucial issue of investigating and comparing the effects of different neural targets. However, at a time when DBS is emerging as a promising investigational treatment modality for AN, lesioning procedures in psychiatry are having a renaissance. Of concern it has been argued that the two kinds of interventions should instead be understood as rivaling, yet “mutually enriching paradigms” despite the fact that lesioning the brain is irreversible and there is no evidence base for an effective target in AN. We argue that lesioning procedures in AN are unethical at this stage of knowledge and seriously problematic for this patient group, for whom self-control is particularly central to wellbeing. They pose a greater risk of major harms that cannot justify ethical equipoise, despite the apparent superiority in reduced short term surgical harms and lower cost. (shrink)

IntroductionDeep brain stimulation (DBS) is increasingly used to treat the symptoms of various neurologic and psychiatric conditions. People can undergo the procedure during reproductive years but the safety of DBS in pregnancy remains relatively unknown given the paucity of published cases. We thus conducted a review of the literature to determine the state of current knowledge about DBS in pregnancy and to determine how eligibility criteria are approached in clinical trials with respect to pregnancy and the potential for (...) pregnancy.MethodsA literature review was conducted in EMBASE to identify articles involving DBS and pregnancy. Two reviewers independently analyzed the articles to confirm inclusion. Data extracted for analysis included conditions treated, complications at all stages of pregnancy, neonatal/pediatric outcomes, and DBS target. A second search was then conducted using www.clinicaltrials.gov. The same two reviewers then assessed whether each trial excluded pregnant individuals, lactating individuals, or persons of childbearing age planning to conceive. Also assessed was whether contraception had to be deemed adequate prior to enrollment.ResultsThe literature search returned 681 articles. Following independent analysis and agreement of two reviewers, 8 pregnancy related DBS articles were included for analysis. These articles described 27 subjects, 29 pregnancies (2 with subsequent pregnancies), and 31 infants (2 twin pregnancies). There was 1 preterm birth at 35 weeks, and 3 patients who experienced discomfort from the DBS battery (i.e., impulse generator) placement site. All 27 patients had a DBS device implanted before they became pregnant, which remained in use throughout their pregnancy. There was exclusion of pregnant individuals from 68% of 135 interventional trials involving DBS. Approximately 44% of these trials excluded persons of childbearing age not on “adequate contraception” or wishing to conceive in the coming years. Finally, 22% excluded breastfeeding persons.ConclusionThe data from 29 pregnancies receiving DBS treatment during pregnancy was not associated with unexpected pregnancy or post-partum complication patterns. Many clinical trials have excluded pregnant individuals. Documentation of outcomes in larger numbers of pregnancies will help clarify the safety profile and will help guide study designs that will safely include pregnant patients. (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 as investigational intervention for symptomatic relief from Alzheimer disease has generated big expectations. Our aim is to discuss the ethical justification of this research agenda by examining the underlying research rationale as well as potential methodological pitfalls. The shortcomings we address are of high ethical importance because only scientifically valid research has the potential to be ethical. We performed a systematic search on MEDLINE and EMBASE. We included 166 publications about DBS for AD into the (...) analysis of research rationale, risks and ethical aspects. Fifty-eight patients were reported in peer-reviewed journals with very mixed results. A grey literature search revealed hints for 75 yet to be published, potentially enrolled patients. The results of our systematic review indicate methodological shortcomings in the literature that are both scientific and ethical in nature. According to our analysis, research with human subjects was performed before decisive preclinical research was published examining the specific research question at stake. We also raise the concern that conclusions on the potential safety and efficacy have been reported in the literature that seem premature given the design of the feasibility studies from which they were drawn. In addition, some publications report that DBS for AD was performed without written informed consent from some patients, but from surrogates only. Furthermore, registered ongoing trials plan to enroll severely demented patients. We provide reasons that this would violate Art. 28 of the Declaration of Helsinki, because DBS for AD involves more than minimal risks and burdens, and because its efficacy and safety are not yet empirically established to be likely. Based on our empirical analysis, we argue that clinical research on interventions of risk class III should not be exploratory but grounded on sound, preclinically tested, and disease-specific a posteriori hypotheses. This also applies to DBS for dementia as long as therapeutic benefits are uncertain, and especially when research subjects with cognitive deficits are involved, who may foreseeably progress to full incapacity to provide informed consent during the required follow-up period. (shrink)

The literature on deep brain stimulation (DBS) and adaptive DBS (aDBS) raises concerns that these technologies may affect personality, mood, and behavior. We conducted semi-structured interviews with researchers (n = 23) involved in developing next-generation DBS systems, exploring their perspectives on ethics and policy topics including whether DBS/aDBS can cause such changes. The majority of researchers reported being aware of personality, mood, or behavioral (PMB) changes in recipients of DBS/aDBS. Researchers offered varying estimates of the frequency of (...) PMB changes. A smaller majority reported changes in personality specifically. Some expressed reservations about the scientific status of the term ‘personality,’ while others used it freely. Most researchers discussed negative PMB changes, but a majority said that DBS/aDBS can also result in positive changes. Several researchers viewed positive PMB changes as part of the therapeutic goal in psychiatric applications of DBS/aDBS. Finally, several discussed potential causes of PMB changes other than the device itself. (shrink)

The critical aspects of deep brain stimulation are usually the focus of the ethical debate about the implantation of electrodes into the brain of patients with Parkinson’s disease. Above all, potential postoperative side effects on personality caused by DBS mark the debate. However, rehabilitation of agility and mobility by DBS can be posited against critical aspects. Therefore, the purpose of this article is to emphasize the hitherto neglected positive aspects of that technology. A detailed study of the (...) rehabilitation of controlled movements will thus be the object of this article. The possibility to move again in a controlled way will be discussed as freedom of movement. The concept freedom of movement is being linked to the observation of feelings of euphoria and joy that can occur after surgery for patients with PD stimulated in the subthalamic nucleus. This is done based on phenomenological analysis and qualitative interviews, in which the relation between freedom of movement and feelings of joy becomes clear. The aim here is to show that these feelings of exaltation express an essential feeling of freedom – a bodily felt freedom – which is grounded in movement and can be regained by STN-DBS. (shrink)

Deep brain stimulation (DBS) of the globus pallidus interna and subthalamic nucleus has restored some degree of motor control in many patients in advanced stages of Parkinson’s disease. DBS has also been used to treat dystonia, essential tremor (progressive neurological condition causing trembling), chronic pain, obsessive-compulsive disorder, Tourette’s syndrome, major depressive disorder, obesity, cerebral palsy, and the minimally conscious state. Although the underlying mechanisms of the technique are still not clear, DBS can modulate underactive or overactive neural circuits (...) and restore disrupted communication between and among groups of neurons in interacting regions of the brain. This can control and relieve many symptoms associated with a range of neurological and psychiatric disorders.But the procedures of implanting and stimulating the electrodes are brain-invasive and entail significant risks. Some patients receiving DBS have experienced intracerebral hemorrhage, infection, cognitive disturbances such as impulsive behavior, and affective disturbances such as mania. It is not known whether continuous electrical stimulation of the brain would reshape synaptic connectivity and permanently alter neural circuits in ways that may not be salutary. The risk of these effects indicates that DBS should be used only when a patient’s condition is refractory to all other interventions and when there is a high probability that the technique will benefit the patient and improve his or her quality of life. If a patient’s quality of life is poor and all other treatment options have been exhausted, then the likelihood of benefit can justify physicians’ exposing patients to some risk. The clinical and ethical significance of the risk in DBS underscores the obligation of physicians to obtain fully informed consent from patients undergoing the procedure. (shrink)