Perceptions of Deep Brain Stimulation for Adolescents with Obsessive-Compulsive Disorder.

Objective: The present study aims to understand perceptions of deep brain stimulation (DBS) for severe obsessive-compulsive disorder (OCD) in adolescents among two groups: parents of children with a history of OCD and adults with a history of OCD. Methods: Two hundred sixty participants completed a questionnaire exploring their treatment history, relevant symptom severity, DBS knowledge, and DBS attitudes using an acceptability scale and a series of statements indicating levels of willingness or reluctance to consider DBS for adolescents with severe OCD or severe epilepsy. Results: Overall, participants found DBS to be fairly acceptable for adolescents with severe OCD, with 63% reporting at least 7/10 on a 0-10 acceptability Likert scale. Respondents were more willing to consider DBS for epilepsy than for OCD. Several factors were associated with greater willingness to consider DBS for OCD, including familiarity with DBS, the presence of suicidal thoughts, assurances of daily functioning improvements, and assurances of substantial symptom reduction. Concerns about safety, personality changes, and long-term effects on the body were associated with greatest reluctance to consider DBS for OCD. Conclusions: Our findings support the importance of increasing parents' familiarity with DBS, monitoring factors participants identified as most important to their DBS perceptions in future DBS research, and communicating benefits and risks clearly. We also highlight the need for further research on perceptions of DBS for severe and refractory OCD in adolescents.

DBS: a compelling example for ethical and legal reflection-a French perspective on ethical and legal concerns about DBS.

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.

A human rights approach to low data reporting in clinical trials of psychiatric deep brain stimulation.

The reporting of clinical trial data is necessary not only for doctors to determine treatment efficacy, but also to explore new questions without unnecessarily repeating trials, and to protect patients and the public from dangers when data are withheld. This issue is particularly salient in those trials involving invasive neurosurgical interventions, such as deep brain stimulation (DBS), for 'treatment refractory' psychiatric disorders. Using the federal database ClinicalTrials.gov, it was discovered that out of the completed or unknown-status trials related to psychiatric DBS up to November 2018, only two had submitted results to ClinicalTrials.gov. These results suggest that, despite federal requirements to report clinical trial data, reporting on psychiatric DBS trials is problematically minimal. It is argued that a human rights approach to this problem establishes a legal and ethical foundation for the need to report clinical trial results in this area.

No going back? Reversibility and why it matters for deep brain stimulation.

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.

Insight and the no-self in deep brain stimulation.

Ethical analyses of the effects of neural interventions commonly focus on changes to personality and behavior, interpreting these changes in terms of authenticity and identity. These phenomena have led to debate among ethicists about the meaning of these terms for ethical analysis of such interventions. While these theoretical approaches have different criteria for ethical significance, they agree that patients' reports are concerning because a sense of self is valuable. In this paper, I question this assumption. I propose that the Buddhist theory of no-self offers a novel approach to making ethical sense of patients' claims following deep brain stimulation. This alternative approach is based on the value of insight into patterns of cause and effect among mental states and actions.

Patient's lived experience with DBS between medical research and care: some legal implications.

In the past 50 years, an ethical-legal boundary has been drawn between treatment and research. It is based on the reasoning that the two activities pursue different purposes. Treatment is aimed at achieving optimal therapeutic benefits for the individual patient, whereas the goal of scientific research is to increase knowledge, in the public interest. From this viewpoint, the patient's experience should be clearly distinguished from that of a participant in a clinical trial. On this premise, two parallel and mutually exclusive regimes have been established. Yet in the case of deep brain stimulation (DBS), this presentation is a poor fit, for both the patient's lived experience and medical practice and research. The frictions may be explained by the specificities of the treatment (including surgery and medical devices) and of the pathologies concerned (chronic and evolutive), and by the characteristics of the medical team implementing the treatment. These particularities challenge the dominant frame of reference in medical bioethics and cause difficulties for the current legal framework in fulfilling its dual role: to protect patients while supporting the development of innovative treatments. The dominant model is still the clinical trial for medication safety and legal requirements of drug market regulation. However, DBS forces us to reflect on a medical device that is permanently implanted in the brain by highly specialized multi-disciplinary neurosurgical teams, for the treatment of chronic evolutive diseases. These devices demand fine-tuning on a case-by-case basis and there is still a lot to discover about why DBS is effective (or not). As a result, the wall between treatment and research is osmotic: many discoveries are made incidentally, in the course of treatment. The following study begins with these observations, and suggests that we review legal provisions (especially in French and United States law) so that they are better adapted to the first-person needs and experience of the patient undergoing brain stimulation.

Moral attitudes and willingness to enhance and repair cognition with brain stimulation.

BACKGROUND: The availability of technological means to enhance and repair human cognitive function raises questions about the perceived morality of their use. However, we have limited knowledge about the public's intuitive attitudes toward uses of brain stimulation. Studies that enlighten us about the public's willingness to endorse specific uses of brain stimulation on themselves and others could provide a basis to understand the moral psychology guiding intuitions about neuromodulation and opportunities to inform public education and public policy. OBJECTIVE: Hypothesis: We expected that subjects would be less willing to enhance or repair cognitive functions perceived as more "core" to "authentic" self-identity, prioritize brain stimulation uses for themselves, and more willing to enhance "core" functions in others. Across specific hypothetical uses, we expected the moral acceptability of specific uses to be associated with subjects' willingness to endorse them. METHODS: We administered two surveys to the public in which subjects were asked to report how willing they would be to enhance or repair specific cognitive abilities using a hypothetical brain stimulation device called "Ceremode". RESULTS: Among 894 subjects, we found that subjects were more willing to use technologies to repair other people than themselves. They were most inclined to repair core functions in others. Subjects' ratings of the moral acceptability of specific uses was related to their reported willingness to use brain stimulation. CONCLUSION: Moral acceptability is related to the public's willingness to use brain stimulation. These findings suggest that the public endorses a generous approach to applying brain stimulation for cognitive gains in others. Further, this study establishes a basis to guide moral psychological studies of cognitive modification and social processes that guide attitudes toward and uses of brain stimulation.

Reader comments to media reports on psychiatric neurosurgery: past history casts shadows on the future.

BACKGROUND: Comments made by readers in response to news articles about current events can provide profound insights into public understanding of and perspectives on those events. Here, in follow up to a paper published last year in this journal, we examined reader comments to articles in newspapers and magazines about neurosurgical interventions for treating psychiatric illness. METHOD: We conducted a thematic analysis of these comments (N = 662 coded units of data) posted in response to 115 newspaper and magazine articles from four countries (Canada, USA, Germany, and Spain) between 2006 and 2017. The comments were coded using an iteratively refined coding scheme that was structured around four a priori categories based on results from the parent study and two new categories that emerged. RESULTS: We found many references to historical psychosurgery and mostly negative and pessimistic comments about ablative neurosurgical interventions. Comments to deep brain stimulation were more positive, and comments to optogenetics most controversial. We also found many expressions of distrust of medical professionals in the context of interventions on the brain and concerns about social and individual control. CONCLUSIONS: Overall, results suggest there is still much work to be done to raise public awareness about re-emerging and new neurosurgical interventions. Balanced discussion is needed if these approaches are to find a place in health care for psychiatric disorders.

Call of Duty at the Frontier of Research: Normative Epistemology for High-Risk/High-Gain Studies of Deep Brain Stimulation.

Research participants are entitled to many rights that may easily come into conflict. The most important ones are that researchers respect their autonomy as persons and act on the principles of beneficence, nonmaleficence, and justice. Since 2014, research subjects from numerous states in the United States of America also have a legal "right to try" that allows them, under certain circumstances, to receive experimental (i.e., preliminarily tested) interventions, including medical devices, before official approval from the United States Food and Drug Administration. In the context of experimental interventions, such as deep brain stimulation (DBS) for Alzheimer's disease, this article argues that research participants ought never to have a legal "right to try" without a corresponding "right to be sure." The latter refers to external epistemic justification construed in terms of reliance on reliable evidence. This article demonstrates that the mere complexity of intervention ensembles, as in the case of DBS for Alzheimer's disease which serves as a paradigm example, illustrate how unanswered and/or unasked open questions give rise to a "combinatorial explosion" of uncertainties that require epistemic responses that no single research team alone is likely able to provide. From this assessment, several epistemic asymmetrical relations between researchers and participants are developed. By elucidating these epistemic asymmetries, this article unravels the reasons why open science, transparent exhaustive data reporting, preregistration, and continued constant critical appraisal via pre- and postpublication peer review are not scientific virtues of moral excellence but rather ordinary obligations of the scientific work routine required to increase reliability and strength of evidence.

Opening the debate on deep brain stimulation for Alzheimer disease - a critical evaluation of rationale, shortcomings, and ethical justification.

BACKGROUND: Deep brain stimulation (DBS) as investigational intervention for symptomatic relief from Alzheimer disease (AD) 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. METHOD: 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. RESULTS: 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. CONCLUSION: Based on our empirical analysis, we argue that clinical research on interventions of risk class III (Food and Drug Administration and European Medicines Agency) 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.

A Personal Narrative on Living and Dealing with Psychiatric Symptoms after DBS Surgery.

Although deep brain stimulation (DBS) may result in dramatic motor improvement in people with Parkinson's disease (PD), it has been correlated with a number of postoperative psychiatric side effects. We report a case of a person with PD experiencing depression and hypomania following DBS surgery. We provide a detailed report of the patient's personal experiences dealing with and managing these psychiatric side effects for three years. Providing a personal narrative focusing on detailed patient subjective experiences complements reports that give insight into the short- and long-term effects of DBS on established psychiatric measures and neurologic activity. But, most importantly, such a qualitative approach provides prospective patients and clinicians with a broader ethical picture of real-life challenges faced and coping strategies employed by PD patients treated with DBS who are experiencing psychiatric adverse events. This case study reinforces the ethical need to disclose the potential risk of harm to prospective patients as well as the importance of establishing a multidisciplinary postoperative supportive group.

Unexpected Complications of Novel Deep Brain Stimulation Treatments: Ethical Issues and Clinical Recommendations.

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.

Clinical Ethics in the Context of Deep Brain Stimulation for Movement Disorders.

OBJECTIVE: Discuss common clinical ethical challenges encountered in working with patients who are candidates for deep brain stimulation (DBS) for the treatment of motor symptoms of Parkinson's disease (PD). METHOD: The relevant literature is reviewed and supplemented by descriptive, ethically challenging cases stemming from decades of combined experience working on DBS teams. We outline ethical arguments and provide pragmatic recommendations to assist neuropsychologists working in movement disorder teams. RESULTS: The goals of the pre-operative neuropsychological DBS assessment include: (1) identification of potential cognitive risk factors; (2) identification of relevant neuropsychiatric or neurobehavioral factors; (3) assessment of level of family support; and (4) systematic assessment of patient's and family member's goals or expectations for DBS. The information gleaned from the pre-operative neuropsychological assessment is highly relevant to the most commonly studied clinical ethics challenges encountered in DBS: (1) assessment of risk/benefit; (2) determinations regarding inclusion/exclusion; (3) autonomy; and (4) patient's perception of benefit and quality of life. CONCLUSIONS: Neuropsychologists are particularly well poised to provide unique and important insights to assist with developing the most ethically sound practices that take into account patient's values as well as fiduciary responsibilities to the patient, the team, the profession, and the broader community.

[Ethical issues relating to deep brain stimulation for psychiatric disorders]. / Ethische overwegingen bij de behandeling van psychiatrische aandoeningen met diepe hersenstimulatie.

BACKGROUND: Deep brain stimulation (dbs) can improve the quality of life of patients with therapy-resistant obsessive compulsive disorder (ocd). For other psychiatric indications, dbs should still be regarded as an experimental treatment.
AIM: To discuss potential ethical issues associated with the use of dbs in the treatment of psychiatric disorders.
METHOD: Ethical discourse.
RESULTS: The ethical issues associated with the use of dbs to treat psychiatric disorders are no different from those that may arise during psychotherapeutic or pharmacological treatments. However, in view of the intensive and invasive nature of dbs, special attention should be given to establishing the indication for dbs treatment and discussions about the continuation or cessation of dbs in case of side-effects or lack of effect. Except in the case of ocd, dbs in psychiatry is provided mainly in a research context in which ethical questions, such as those relating to competence, need to be carefully considered.
CONCLUSION: The basic ethical principles in medicine generally provide an adequate basis for guiding clinical decisions relating to the use of dbs in the treatment of psychiatric disorders. However, as dbs treatment for psychiatric disorders continues to develop, proactive reflection on ethical issues is warranted.

Deep brain stimulation for disorders of consciousness: Systematic review of cases and ethics.

BACKGROUND: A treatment for patients suffering from prolonged severely altered consciousness is not available. The success of Deep Brain Stimulation (DBS) in diseases such as Parkinson's, dystonia and essential tremor provided a renewed impetus for its application in Disorders of Consciousness (DoC). OBJECTIVE: To evaluate the rationale for DBS in patients with DoC, through systematic review of literature containing clinical data and ethical considerations. METHODS: Articles from PubMed, Embase, Medline and Web of Science were systematically reviewed. RESULTS: The outcomes of 78 individual patients reported in 19 articles from 1968 onwards were pooled and elements of ethical discussions were compared. There is no clear clinical evidence that DBS is a treatment for DoC that can restore both consciousness and the ability to communicate. In patients who benefitted, the outcome of DBS is often confounded by the time frame of spontaneous recovery from DoC. Difficult ethical considerations remain, such as the risk of increasing self-awareness of own limitations, without improving overall wellbeing, and the issues of proxy consent. CONCLUSION: DBS is far from being evident as a possible future therapeutic avenue for patients with DoC. Double-blind studies are lacking, and many clinical and ethical issues have to be addressed. In the rare cases when DBS for patients with DoC is considered, this needs to be evaluated meticulously on a case by case basis, with comprehensive overall outcome measures including psychological and quality-of-life assessments, and with the guidance of an ethical and interdisciplinary panel, especially in relation to proxy consent.

Deep Brain Stimulation, Authenticity and Value.

In this article, 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 peoples' convictions about the true self should be interpreted in essentialist or existentialist ways. Like Pugh, Maslen, and Savulescu, 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 determine what such shared values mean to them, as it can be alienating for patients if they feel that others try to impose values on them from the outside.

Deep Brain Stimulation, Authenticity and Value.

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.