Post-trial access to implantable neural devices: an exploratory international survey.

Objectives: Clinical trials of innovative neural implants are rapidly increasing and diversifying, but little is known about participants' post-trial access to the device and ongoing clinical care. This exploratory study examines common practices in the planning and coordination of post-trial access to neurosurgical devices. We also explore the perspectives of trial investigators on the barriers to post-trial access and ongoing care, as well as ethical questions related to the responsibilities of key stakeholder groups. Design setting and participants: Trial investigators (n=66) completed a survey on post-trial access in the most recent investigational trial of a surgically implanted neural device they had conducted. Survey respondents predominantly specialized in neurosurgery, neurology and psychiatry, with a mean of 14.8 years of experience working with implantable neural devices. Main outcome measures: Outcomes of interest included rates of device explantation during or at the conclusion of the trial (pre-follow-up) and whether plans for post-trial access were described in the study protocol. Outcomes also included investigators' greatest 'barrier' and 'facilitator' to providing research participants with post-trial access to functional implants and perspectives on current arrangements for the sharing of post-trial responsibilities among key stakeholders. Results: Trial investigators reported either 'all' (64%) or 'most' (33%) trial participants had remained implanted after the end of the trial, with 'infection' and 'non-response' the most common reasons for explantation. When asked to describe the main barriers to facilitating post-trial access, investigators described limited funding, scarcity of expertise and specialist clinical infrastructure and difficulties maintaining stakeholder relationships. Notwithstanding these barriers, investigators overwhelmingly (95%) agreed there is an ethical obligation to provide post-trial access when participants individually benefit during the trial. Conclusions: On occasions when devices were explanted during or at the end of the trial, this was done out of concern for the safety and well-being of participants. Further research into common practices in the post-trial phase is needed and essential to ethical and pragmatic discussions regarding stakeholder responsibilities.

Interdisciplinary perspectives on digital technologies for global mental health.

Digital Mental Health Technologies (DMHTs) have the potential to close treatment gaps in settings where mental healthcare is scarce or even inaccessible. For this, DMHTs need to be affordable, evidence-based, justice-oriented, user-friendly, and embedded in a functioning digital infrastructure. This viewpoint discusses areas crucial for future developments of DMHTs. Drawing back on interdisciplinary scholarship, questions of health equity, consumer-, patient- and developer-oriented legislation, and requirements for successful implementation of technologies across the globe are discussed. Economic considerations and policy implications complement these aspects. We discuss the need for cultural adaptation specific to the context of use and point to several benefits as well as pitfalls of DMHTs for research and healthcare provision. Nonetheless, to circumvent technology-driven solutionism, the development and implementation of DMHTs require a holistic, multi-sectoral, and participatory approach.

Minding Rights: Mapping Ethical and Legal Foundations of 'Neurorights'.

The rise of neurotechnologies, especially in combination with artificial intelligence (AI)-based methods for brain data analytics, has given rise to concerns around the protection of mental privacy, mental integrity and cognitive liberty - often framed as "neurorights" in ethical, legal, and policy discussions. Several states are now looking at including neurorights into their constitutional legal frameworks, and international institutions and organizations, such as UNESCO and the Council of Europe, are taking an active interest in developing international policy and governance guidelines on this issue. However, in many discussions of neurorights the philosophical assumptions, ethical frames of reference and legal interpretation are either not made explicit or conflict with each other. The aim of this multidisciplinary work is to provide conceptual, ethical, and legal foundations that allow for facilitating a common minimalist conceptual understanding of mental privacy, mental integrity, and cognitive liberty to facilitate scholarly, legal, and policy discussions.

Neurofeminism: Feminist critiques of research on sex/gender differences in the neurosciences.

Over the last three decades, the human brain and its role in determining behavior have been receiving a growing amount of attention in academia as well as in society more generally. Neuroscientific explanations of human behavior or other phenomena are often especially appealing to lay people. Therefore, neuroscientific explanations that can affect individuals, groups, or social relations in general should be formulated in a careful and responsible way. One field in which especially feminist scholars request more caution is the neuroscientific examination of sex/gender differences. Feminist scholars have described various ways in which sexist bias might be present in neuroscientific research on sex/gender differences. In this context, they coined the term "neurosexism" to describe the entanglement between neuroscientific work and sexist ideology, and "neurofeminism" as a response to that. Here, we aim to give an overview over the contemporary neurofeminist literature. In the first part, common levels of analysis in the neurofeminist literature are presented and the research level is explored in more detail. In the second part, some common developments in more recent neurofeminist scholarship are discussed. For this, we review recent publications with the aim to provide neuroscientists with a solid understanding of neurofeminist criticism so that they may evaluate neuroscientific claims about on sex/gender differences from this critical perspective.

Towards a Toolbox for Privacy-Preserving Computation on Health Data.

Substantial advances in methods of collecting and aggregating large amounts of biomedical data have been met with insufficient measures of protecting it from unwarranted access and use. Most of the current layers of protection are merely aimed at ensuring compliance with regulations (e.g., the EU's General Data Protection Regulation) but do not represent a vision of privacy-by-design as an efficient and ethical advantage in biomedical research and clinical applications. This not only slows down the pace of such efforts but also leaves the data exposed to a wide spectrum of cyberattacks. This work presents an overview of recent advancements in data and compuation security, along with a discussion of their limitations and potential for deployement in both health care and research settings.

MedSentinel - A Smart Sentinel for Biomedical Online Search Demonstrated by a COVID-19 Search.

We present a work-in-progress software project which aims to assist cross-database medical research and knowledge acquisition from heterogeneous sources. Using a Natural Language Processing (NLP) model based on deep learning algorithms, topical similarities are detected, going beyond measures of connectivity via citation or database suggestion algorithms. A network is generated based on the NLP-similarities between them, and then presented within an explorable 3D environment. Our software will then generate a list of publications and datasets which pertain to a certain topic of interest, based on their level of similarity in terms of knowledge representation.

Is Virtually Everything Possible? The Relevance of Ethics and Human Rights for Introducing Extended Reality in Forensic Psychiatry.

Extended Reality (XR) systems, such as Virtual Reality (VR) and Augmented Reality (AR), provide a digital simulation either of a complete environment, or of particular objects within the real world. Today, XR is used in a wide variety of settings, including gaming, design, engineering, and the military. In addition, XR has been introduced into psychology, cognitive sciences and biomedicine for both basic research as well as diagnosing or treating neurological and psychiatric disorders. In the context of XR, the simulated 'reality' can be controlled and people may safely learn to cope with their feelings and behavior. XR also enables to simulate environments that cannot easily be accessed or created otherwise. Therefore, Extended Reality systems are thought to be a promising tool in the resocialization of criminal offenders, more specifically for purposes of risk assessment and treatment of forensic patients. Employing XR in forensic settings raises ethical and legal intricacies which are not raised in case of most other healthcare applications. Whereas a variety of normative issues of XR have been discussed in the context of medicine and consumer usage, the debate on XR in forensic settings is, as yet, straggling. By discussing two general arguments in favor of employing XR in criminal justice, and two arguments calling for caution in this regard, the present paper aims to broaden the current ethical and legal debate on XR applications to their use in the resocialization of criminal offenders, mainly focusing on forensic patients.

Engineering Minds? Ethical Considerations on Biotechnological Approaches to Mental Health, Well-Being, and Human Flourishing.

Our bodies can be designed and modified in accordance with our ideals of health and well-being. These increasingly targeted and personalized interventions will be more effective than current therapies. Here we review technologies to alter mood, and explore the ethics of bioengineering approaches to mental health.

Recommendations for Responsible Development and Application of Neurotechnologies.

Advancements in novel neurotechnologies, such as brain computer interfaces (BCI) and neuromodulatory devices such as deep brain stimulators (DBS), will have profound implications for society and human rights. While these technologies are improving the diagnosis and treatment of mental and neurological diseases, they can also alter individual agency and estrange those using neurotechnologies from their sense of self, challenging basic notions of what it means to be human. As an international coalition of interdisciplinary scholars and practitioners, we examine these challenges and make recommendations to mitigate negative consequences that could arise from the unregulated development or application of novel neurotechnologies. We explore potential ethical challenges in four key areas: identity and agency, privacy, bias, and enhancement. To address them, we propose (1) democratic and inclusive summits to establish globally-coordinated ethical and societal guidelines for neurotechnology development and application, (2) new measures, including "Neurorights," for data privacy, security, and consent to empower neurotechnology users' control over their data, (3) new methods of identifying and preventing bias, and (4) the adoption of public guidelines for safe and equitable distribution of neurotechnological devices.

Ethics of Digital Mental Health During COVID-19: Crisis and Opportunities.

Social distancing measures due to the COVID-19 pandemic have accelerated the adoption and implementation of digital mental health tools. Psychiatry and therapy sessions are being conducted via videoconferencing platforms, and the use of digital mental health tools for monitoring and treatment has grown. This rapid shift to telehealth during the pandemic has given added urgency to the ethical challenges presented by digital mental health tools. Regulatory standards have been relaxed to allow this shift to socially distanced mental health care. It is imperative to ensure that the implementation of digital mental health tools, especially in the context of this crisis, is guided by ethical principles and abides by professional codes of conduct. This paper examines key areas for an ethical path forward in this digital mental health revolution: privacy and data protection, safety and accountability, and access and fairness.

Trust in socially assistive robots: Considerations for use in rehabilitation.

Incorporation of social robots into rehabilitation calls for understanding what factors affect user motivation and success of the interaction. Trust between the user and the robot has been identified as important in human-robot interaction and in human-human interactions in therapy. Trust has been studied in the context of automation technology, (e.g., autonomous cars), but not in the context of social robots for rehabilitation. In this narrative review, we address the unique patient-clinician-robot triad, and argue that this context calls for specific design features in order to foster trust with the users. We review pertinent methods for measuring trust, and studies demonstrating that culture, prior experience and propensity-to-trust affect to what extent users trust robots. We suggest design guidelines for fostering trust and methods for measuring trust in human-robot interactions in rehabilitation. We stress the need to create measures of trust that are accessible to people who suffer from speech or cognitive impairments. This review is pertinent to researchers, roboticists, and clinicians interested in designing and using social robots for rehabilitation.

A transcallosal fibre system between homotopic inferior frontal regions supports complex linguistic processing.

Inferior frontal regions in the left and right hemisphere support different aspects of language processing. In the canonical model, left inferior frontal regions are mostly involved in processing based on phonological, syntactic and semantic features of language, whereas the right inferior frontal regions process paralinguistic aspects like affective prosody. Using diffusion tensor imaging (DTI)-based probabilistic fibre tracking in 20 healthy volunteers, we identify a callosal fibre system connecting left and right inferior frontal regions that are involved in linguistic processing of varying complexity. Anatomically, we show that the interhemispheric fibres are highly aligned and distributed along a rostral to caudal gradient in the body and genu of the corpus callosum to connect homotopic inferior frontal regions. In the light of converging data, taking previous DTI-based tracking studies and clinical case studies into account, our findings suggest that the right inferior frontal cortex not only processes paralinguistic aspects of language (such as affective prosody), as purported by the canonical model, but also supports the computation of linguistic aspects of varying complexity in the human brain. Our model may explain patterns of right-hemispheric contribution to stroke recovery as well as disorders of prosodic processing. Beyond language-related brain function, we discuss how inter-species differences in interhemispheric connectivity and fibre density, including the system we described here may also explain differences in transcallosal information transfer and cognitive abilities across different mammalian species.

Neurophilosophical and Ethical Aspects of Virtual Reality Therapy in Neurology and Psychiatry.

Highly immersive virtual reality (VR) systems have been introduced into the consumer market in recent years. The improved technological capabilities of these systems as well as the combination with biometric sensors, for example electroencephalography (EEG), in a closed-loop hybrid VR-EEG, opens up a range of new potential medical applications. This article first provides an overview of the past and current clinical applications of VR systems in neurology and psychiatry and introduces core concepts in neurophilosophy and VR research (such as agency, trust, presence, and others). Then, important adverse effects of highly immersive VR simulations and the ethical implications of standalone and hybrid VR systems for therapy in neurology and psychiatry are highlighted. These new forms of VR-based therapy may strengthen patients in exercising their autonomy. At the same time, however, these emerging systems present ethical challenges, for example in terms of moral and legal accountability in interactions involving "intelligent" hybrid VR systems. A user-centered approach that is informed by the target patients' needs and capabilities could help to build beneficial systems for VR therapy.

Electrophysiological correlates of neurodegeneration in motor and non-motor brain regions in amyotrophic lateral sclerosis-implications for brain-computer interfacing.

OBJECTIVE: For patients with amyotrophic lateral sclerosis (ALS) who are suffering from severe communication or motor problems, brain-computer interfaces (BCIs) can improve the quality of life and patient autonomy. However, current BCI systems are not as widely used as their potential and patient demand would let assume. This underutilization is a result of technological as well as user-based limitations but also of the comparatively poor performance of currently existing BCIs in patients with late-stage ALS, particularly in the locked-in state. APPROACH: Here we review a broad range of electrophysiological studies in ALS patients with the aim to identify electrophysiological correlates of ALS-related neurodegeneration in motor and non-motor brain regions in to better understand potential neurophysiological limitations of current BCI systems for ALS patients. To this end we analyze studies in ALS patients that investigated basic sensory evoked potentials, resting-state and task-based paradigms using electroencephalography or electrocorticography for basic research purposes as well as for brain-computer interfacing. Main results and significance. Our review underscores that, similarly to mounting evidence from neuroimaging and neuropathology, electrophysiological measures too indicate neurodegeneration in non-motor areas in ALS. Furthermore, we identify an unexpected gap of basic and advanced electrophysiological studies in late-stage ALS patients, particularly in the locked-in state. We propose a research strategy on how to fill this gap in order to improve the design and performance of future BCI systems for this patient group.

Social robots in rehabilitation: A question of trust.

Social robots can help meet the growing need for rehabilitation assistance; measures for creating and maintaining trust in human-robot interactions should be priorities when designing social robots for rehabilitation.

Ethical and Legal Implications of the Methodological Crisis in Neuroimaging.

Currently, many scientific fields such as psychology or biomedicine face a methodological crisis concerning the reproducibility, replicability, and validity of their research. In neuroimaging, similar methodological concerns have taken hold of the field, and researchers are working frantically toward finding solutions for the methodological problems specific to neuroimaging. This article examines some ethical and legal implications of this methodological crisis in neuroimaging. With respect to ethical challenges, the article discusses the impact of flawed methods in neuroimaging research in cognitive and clinical neuroscience, particularly with respect to faulty brain-based models of human cognition, behavior, and personality. Specifically examined is whether such faulty models, when they are applied to neurological or psychiatric diseases, could put patients at risk, and whether this places special obligations on researchers using neuroimaging. In the legal domain, the actual use of neuroimaging as evidence in United States courtrooms is surveyed, followed by an examination of ways that the methodological problems may create challenges for the criminal justice system. Finally, the article reviews and promotes some promising ideas and initiatives from within the neuroimaging community for addressing the methodological problems.

The Effects of Closed-Loop Medical Devices on the Autonomy and Accountability of Persons and Systems.

Closed-loop medical devices such as brain-computer interfaces are an emerging and rapidly advancing neurotechnology. The target patients for brain-computer interfaces (BCIs) are often severely paralyzed, and thus particularly vulnerable in terms of personal autonomy, decisionmaking capacity, and agency. Here we analyze the effects of closed-loop medical devices on the autonomy and accountability of both persons (as patients or research participants) and neurotechnological closed-loop medical systems. We show that although BCIs can strengthen patient autonomy by preserving or restoring communicative abilities and/or motor control, closed-loop devices may also create challenges for moral and legal accountability. We advocate the development of a comprehensive ethical and legal framework to address the challenges of emerging closed-loop neurotechnologies like BCIs and stress the centrality of informed consent and refusal as a means to foster accountability. We propose the creation of an international neuroethics task force with members from medical neuroscience, neuroengineering, computer science, medical law, and medical ethics, as well as representatives of patient advocacy groups and the public.