Deep brain stimulation — a novel surgical procedure — is emerging as a treatment of last resort for people diagnosed with neuropsychiatric disorders such as severe obsessive-compulsive disorder. The US Food and Drug Administration granted a so-called humanitarian device exemption to allow patients to access this intervention, thereby removing the requirement for a clinical trial of the appropriate size and statistical power. Bypassing the rigors of such trials puts patients at risk, limits opportunities for scientific discovery, and gives device manufacturers (...) unique marketing opportunities. We argue that Congress and federal regulators should revisit the humanitarian device exemption to ensure that it is not used to sidestep careful research that can offer valuable data with appropriate patient safeguards. (shrink)

Neurosurgery for psychiatric disorders, also sometimes referred to as psychosurgery, is rapidly evolving, with new techniques and indications being investigated actively. Many within the field have suggested that some form of guidelines or regulations are needed to help ensure that a promising field develops safely. Multiple countries have enacted specific laws regulating NPD. This article reviews NPD-specific laws drawn from North and South America, Asia and Europe, in order to identify the typical form and contents of these laws and to (...) set the groundwork for the design of an optimal regulation for the field. Key challenges for this design that are revealed by the review are how to define the scope of the law, what types of regulations are required, and how to approach international harmonization given the potential migration of researchers and patients. (shrink)

Precision targeting of specific white matter bundles that traverse the subcallosal cingulate has been linked to efficacy of deep brain stimulation for treatment resistant depression. Methods to confirm optimal target engagement in this heterogenous region are now critical to establish an objective treatment protocol. As yet unexamined are the time-frequency features of the SCC evoked potential, including spectral power and phase-clustering. We examined these spectral features—evoked power and phase clustering—in a sample of TRD patients with implanted SCC stimulators. Electroencephalogram was (...) recorded during wakeful rest. Location of electrical stimulation in the SCC target region was the experimental manipulation. EEG was analyzed at the surface level with an average reference for a cluster of frontal sensors and at a time window identified by prior study. Morlet wavelets generated indices of evoked power and inter-trial phase clustering. Enhanced phase clustering at theta frequency was observed in every subject and was significantly correlated with SCC-EP magnitude, but only during left SCC stimulation. Stimulation to dorsal SCC evinced stronger phase clustering than ventral SCC. There was a weak correlation between phase clustering and white matter density. An increase in evoked delta power was also coincident with SCC-EP, but was less consistent across participants. DBS evoked time-frequency features index mm-scale changes to the location of stimulation in the SCC target region and correlate with structural characteristics implicated in treatment optimization. Results also imply a shared generative mechanism between evoked potentials evinced by electrical stimulation and evoked potentials evinced by auditory/visual stimuli and behavioral tasks. Understanding how current injection impacts downstream cortical activity is essential to building new technologies that adapt treatment parameters to individual differences in neurophysiology. (shrink)

What happens at the end of a clinical trial for an investigational neural implant? It may be surprising to learn how difficult it is to answer this question. While new trials are initiated with increasing regularity, relatively little consensus exists on how best to conduct them, and even less on how to ethically end them. The landscape of recent neural implant trials demonstrates wide variability of what happens to research participants after an neural implant trial ends. Some former research participants (...) continue to receive support for their devices (e.g., battery and component replacements, software updates, etc.). Others, when safe, have their neural implants removed through surgical explantation. Still others continue to live with a deactivated neural implant embedded in their body. In the United States, there are no uniform requirements to provide services, of any kind, after an neural implant study ends, and other nations are similarly facing this challenge. The existence of a post-trial gap in an expanding neural implant research ecosystem invites obvious questions: What is owed to neural implant research participants post-trial, and why has providing it been so difficult to accomplish in practice? To take a step forward on this difficult issue, we assembled one group of stakeholders – researchers funded for neuroethics grants by the National Institutes of Health – to explore possible starting points on one topic: ethical guidance for post-trial care of research participants in neural implant trials. Based on shared concerns discussed in the expert workshop the current paper is a call to action. It reports the key areas of convergence from the meeting and highlights important next steps towards developing much needed guidance. (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)

Background: Electroconvulsive therapy is one of the most effective treatments for major depressive disorder. Recently, there has been increasing attention to evaluate the effect of ECT on resting-state functional magnetic resonance imaging. This study aims to compare rs-fMRI of depressive disorder patients with healthy participants, investigate whether pre-ECT dynamic functional network connectivity network estimated from patients rs-fMRI is associated with an eventual ECT outcome, and explore the effect of ECT on brain network states.Method: Resting-state functional magnetic resonance imaging data were (...) collected from 119 patients with depression or depressive disorder, and 61 healthy participants, with an age mean of 52.25 years old. The pre-ECT and post-ECT Hamilton Depression Rating Scale were 25.59 ± 6.14 and 11.48 ± 9.07, respectively. Twenty-four independent components from default mode and cognitive control network were extracted, using group-independent component analysis from pre-ECT and post-ECT rs-fMRI. Then, the sliding window approach was used to estimate the pre-and post-ECT dFNC of each subject. Next, k-means clustering was separately applied to pre-ECT dFNC and post-ECT dFNC to assess three distinct states from each participant. We calculated the amount of time each subject spends in each state, which is called “occupancy rate” or OCR. Next, we compared OCR values between HC and DEP participants. We also calculated the partial correlation between pre-ECT OCRs and HDRS change while controlling for age, gender, and site. Finally, we evaluated the effectiveness of ECT by comparing pre- and post-ECT OCR of DEP and HC participants.Results: The main findings include depressive disorder patients had significantly lower OCR values than the HC group in state 2, where connectivity between cognitive control network and default mode network was relatively higher than other states, Pre-ECT OCR of state, with more negative connectivity between CCN and DMN components, is linked with the HDRS changes. This means that those DEP patients who spent less time in this state showed more HDRS change, and The post-ECT OCR analysis suggested that ECT increased the amount of time DEP patients spent in state 2.Conclusion: Our finding suggests that dynamic functional network connectivity features, estimated from CCN and DMN, show promise as a predictive biomarker of the ECT outcome of DEP patients. Also, this study identifies a possible underlying mechanism associated with the ECT effect on DEP patients. (shrink)

DBS Think Tank IX was held on August 25–27, 2021 in Orlando FL with US based participants largely in person and overseas participants joining by video conferencing technology. The DBS Think Tank was founded in 2012 and provides an open platform where clinicians, engineers and researchers can freely discuss current and emerging deep brain stimulation technologies as well as the logistical and ethical issues facing the field. The consensus among the DBS Think Tank IX speakers was that DBS expanded in (...) its scope and has been applied to multiple brain disorders in an effort to modulate neural circuitry. After collectively sharing our experiences, it was estimated that globally more than 230,000 DBS devices have been implanted for neurological and neuropsychiatric disorders. As such, this year’s meeting was focused on advances in the following areas: neuromodulation in Europe, Asia and Australia; cutting-edge technologies, neuroethics, interventional psychiatry, adaptive DBS, neuromodulation for pain, network neuromodulation for epilepsy and neuromodulation for traumatic brain injury. (shrink)

We characterize, in syntactic terms, the ranges of epimorphisms in an arbitrary class of similar first-order structures. This allows us to strengthen a result of Bacsich, as follows: in any prevariety having at most \ non-logical symbols and an axiomatization requiring at most \ variables, if the epimorphisms into structures with at most \ elements are surjective, then so are all of the epimorphisms. Using these facts, we formulate and prove manageable ‘bridge theorems’, matching the surjectivity of all epimorphisms in (...) the algebraic counterpart of a logic \ with suitable infinitary definability properties of \, while not making the standard but awkward assumption that \ comes furnished with a proper class of variables. (shrink)

It was shown recently that epimorphisms need not be surjective in a variety K of Heyting algebras, but only one counter-example was exhibited in the literature until now. Here, a continuum of such examples is identified, viz. the variety generated by the Rieger-Nishimura lattice, and all of its (locally finite) subvarieties that contain the original counter-example K . It is known that, whenever a variety of Heyting algebras has finite depth, then it has surjective epimorphisms. In contrast, we show that (...) for every integer $n \geq 2$ , the variety of all Heyting algebras of width at most n has a non-surjective epimorphism. Within the so-called Kuznetsov-Gerčiu variety (i.e., the variety generated by finite linear sums of one-generated Heyting algebras), we describe exactly the subvarieties that have surjective epimorphisms. This yields new positive examples, and an alternative proof of epimorphism surjectivity for all varieties of Gödel algebras. The results settle natural questions about Beth-style definability for a range of intermediate logics. (shrink)

This paper deals with the axiomatizability problem for the matrix-based logics RMQ − and RMQ *. We present a Hilbert-style axiom system for RMQ −, and a quasi-axiomatization based on it for RMQ *. We further compare these logics to different well-known modal logics, and assess its status as relevance logics.

: This contribution offers a detailed presentation of an anonymous book on the soul ascribed to the fourteenth-century Franciscan philosopher and theologian Nicholas Bonet. The work is conserved in two manuscripts of the National Library of the Czech Republic in Prague. In both manuscripts the work is almost certainly incomplete. It has a strong focus on the vegetative and sensitive operations of the human soul and on phenomena such as light and colour. Keywords: Fourteenth-century philosophy, Nicholas Bonet, philosophical manuscripts, philosophical (...) psychology, the soul. (shrink)

There have been two main lines in the literature on restricted games: the first line was started by Myerson (1977) that studied graph-restricted games an the second one was initiated by Faigle (1989). The present paper provides a unified way to look on the literature and establishes connections between the two different lines on restricted games. The strength and advantages of this unified approach becomes clear in the study of the inheritance of the convexity from the game to the restricted (...) game where an interesting result by Nouweland and Borm (1991) on the convexity of graph-restricted games is turned into a direct consequence of the corresponding result by Faigle (1989), by means of this relation. (shrink)

Descartes, Boyle and Hooke shared, with many other seventeenth-century figures, the view that mechanical explanations were the only intellectually satisfactory ones. They also all accepted the view that we have incorporeal souls. This generated a problem for them when they wrote about perception. In this area, indeed, Descartes seems to be almost a reluctant Cartesian. When we read his scientific writings, the incorporeal soul is not stressed, and Descartes happily speaks of physical, or of corporeal, ideas in discussing sensation, memory (...) and imagination. (shrink)

Dans toutes les sciences, même en physique, la réflexion sur les expériences, les concepts et les explications oblige à repenser l'opposition de la nature et de l'esprit. C'est en raison de cela que la psychologie s'est vue contrainte de revoir la conception traditionelle concernant la relation de l'âme et du corps. Le corps est un système d'équilibres intérieurs qui ont une signification et qui, dans le courant de l'existence sont formés, entretenus, troublés et rétablis. En tout cela motivations psychologiques et (...) occasions corporelles sont intimement mêlées. Ceci est illustré par deux exemples, la conservation de la constance de la température du corps et de l'état de nutrition. La stabilité du « milieu interne » , C. à. d. l'homéostase, est la condition de l'indépendance individuelle de l'animal, et elle est le point d'appui de la liberté personnelle de l'homme. La régulation thermique est le fait de fonctions physiologiques qui s'exercent en accord avec l'existence personnelle. Cette liaison de l'existence et de la vie s'explique par le fait que, corporellement, l'homme ne réagit pas à des excitants physiques, mais à leur signification humaine. La régulation thermique dépend de la sensation de froid et de chaud et par conséquent aussi de relations et d'habitudes humaines. Le second exemple, de l'homéostase, de la conservation d'un état constant de nutrition, démontre, tout comme la régulation thermique, l'unité d'un état physiologique et du corps comme situation vécue. Ceci nous est montré par l'exemple de l'appétit qui dépend sans dute de sensations corporelles et d'équilibres intérieurs, mais tout autant des relations affectives. Le manque d'appétit, l'anorexie nerveuse, comme on l'appelle, se produit souvent d'une manière symptomatique dans les périodes critiques de l'existence, p. ex. à la puberté, au climacterium et à l'occasion de conflits psychiques. Il y a alors une disproportion entre le vouloir et le pouvoir que le psychologue ne peut comprendre que par rapport à la corporéité animée et animante, c'est à dire par le fait que la corporéité déjà organisée entre en conflit avec la corporéité organisante qui est constituée et par la motivation de la situation et par la liberté relative de l'homme qui donne à cette situation un sens déterminé. L'existence et la vie sont deux aspects de la réalité humaine, aspects qui sont susceptibles d'être analysés et auxquels le psychologue doit accorder son attention. La personne concrète est une unité de nécessité et de liberté, de nature et d'esprit, qui se forme elle-même dans sa vivante existence. (shrink)

We analyse the relationship between applicability and effectiveness of legal norms from a philosophical perspective. In particular, we distinguish between two concepts of applicability. The external applicability of norms refers to institutional duties; a norm N is externally applicable if and only if a judge is legally obliged to apply N to some case c. Internal applicability refers instead to the sphere of validity of legal norms. A norm N is internally applicable to actions regulated by its sphere of validity. (...) We also explore the consequences of a thesis which maintains that applicability restricts the concept of effectiveness, so that only applicable norms can be considered effective. Our analysis illustrates that a proper reconstruction of the concept of applicability is of great importance not only for understanding the concept of effectiveness but also for providing insight into the nature of law. (shrink)

Medical electives have long been part of the undergraduate curriculum, and many students choose to undertake a placement in a developing country. In countries where healthcare provision is hugely underresourced, students have found themselves under pressure to exceed their role. They have been expected to diagnose and treat patients without direct supervision from a qualified doctor. Some have found themselves running clinics and wards; others have found themselves to be the most qualified person available.1,2The British Medical Journal believes students should (...) not take on the role of a qualified doctor, “irrespective of any encouragement which students may receive from members of the host organisations to which they are attached”.3 This includes not diagnosing, prescribing, or treating any patient without strict clinical supervision. They feel that students fail to appreciate the dangers of treatment, particularly where familiar medical problems are complicated by unfamiliar poverty. Their deontological view is saying that students should treat their work …. (shrink)