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)

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)

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)

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)

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)

This article attempts to illustrate the originality, depth, and farsightedness of Joseph Raz's conception, especially his idea that legal norms provide us with protected reasons to act, that is, with first-order reasons to behave as they prescribe, and with second-order, exclusionary reasons not to act for reasons against what they prescribe. But the article also highlights some aspects that raise doubts in my mind, especially with regard to the scope of these exclusionary reasons. This in two ways: by asking, on (...) the one hand, in what sense and subject to what limits legal norms provide exclusionary reasons for the organs entrusted with applying the law, especially for judges, and on the other hand, how and to what extent legal norms provide citizens with exclusionary reasons. So, in recognizing the strength of the Razian conception, the article also points to some of the difficulties it faces. (shrink)

In his discussion note ‘J. J. C. Smart, Materialism and Occam's Razor’ Peter Glassen argues that it was inconsistent of me both to assert that realism is true and that Occam's razor is a reason for the materialist thesis. Glassen says that Occam's razor ‘ is not a physical thing, state or process at all ’. A little further down on the same page he uses the phrase ‘material or physical thing, state, or process’. It is possible, therefore, that Glassen (...) regards the distinction between ‘material’ and ‘physical’ as unimportant in the present context. I think however that one way of replying to Glassen turns on this distinction. (shrink)

The main purpose of this paper is to seek a reconciliation between two apparently conflicting views of mine. I have argued (for example, Smart, 1963) for realism about theoretical entities, for example electrons, protons, photons, possibly space-time points, perhaps the ‘Y’-wave of Schrödinger’s equation and so on. Quine has also plausibly argued that we should believe in mathematical entities, since in physics we quantify over them no less than over electrons and protons. I except cases in which in physics the (...) existential quantifications are part of merely pretence discourse. Perhaps in spherical astronomy talk of the celestial sphere should be treated in this way. Alternatively the celestial sphere could be thought of realistically as a sphere whose centre is that of the earth while the stars and planets are thought of (or correlated with) points or small areas on the sphere’s surface in their lines of sight. I am not concerned in this paper to delimit fact from fiction in scientific discourse. The settlement of borderline disputes can wait for another occasion. My main argument for scientific realism is the cosmic coincidence argument. Would it not be a cosmic coincidence if the world were merely as if there were electrons, protons, etc?1. (shrink)

Robert Boyle, one of the most important intellectuals of the seventeenth century, was a gifted experimenter, an exceptionally able philosopher, and a dedicated Christian. In Boyle’s two _Excellencies_, _The Excellency of Theology Compared with Natural Philosophy_ and _About The Excellency and Grounds of the Mechanical Hypothesis_, he explains and justifies his new philosophy of science while reconciling it with Christian theology. These pioneering works of early science and theology are now available in a modernized and accessible new edition. This Broadview (...) edition brings spelling and punctuation into line with current conventions and includes notes and references to set the works in their historical and philosophical context. The appendices include works by Boyle’s predecessors in the philosophy of science, other philosophical writings by Boyle, and an appendix of the other figures mentioned in the texts. (shrink)

Opstellen van een hoogleraar in de wijsbegeerte.

Two essays on utilitarianism, written from opposite points of view, by J. J. C. Smart and Bernard Williams. In the first part of the book Professor Smart advocates a modern and sophisticated version of classical utilitarianism; he tries to formulate a consistent and persuasive elaboration of the doctrine that the rightness and wrongness of actions is determined solely by their consequences, and in particular their consequences for the sum total of human happiness. In Part II Bernard Williams offers a sustained (...) and vigorous critique of utilitarian assumptions, arguments and ideals. He finds inadequate the theory of action implied by utilitarianism, and he argues that utilitarianism fails to engage at a serious level with the real problems of moral and political philosophy, and fails to make sense of notions such as integrity, or even human happiness itself. This book should be of interest to welfare economists, political scientists and decision-theorists. (shrink)

A many-valued (aka multiple- or multi-valued) semantics, in the strict sense, is one which employs more than two truth values; in the loose sense it is one which countenances more than two truth statuses. So if, for example, we say that there are only two truth values—True and False—but allow that as well as possessing the value True and possessing the value False, propositions may also have a third truth status—possessing neither truth value—then we have a many-valued semantics in the (...) loose but not the strict sense. A many-valued logic is one which arises from a many-valued semantics and does not also arise from any two-valued semantics [Malinowski, 1993, 30]. By a ‘logic’ here we mean either a set of tautologies, or a consequence relation. We can best explain these ideas by considering the case of classical propositional logic. The language contains the usual basic symbols (propositional constants p, q, r, . . .; connectives ¬, ∧, ∨, →, ↔; and parentheses) and well-formed formulas are defined in the standard way. With the language thus specified—as a set of well-formed formulas—its semantics is then given in three parts. (i) A model of a logical language consists in a free assignment of semantic values to basic items of the non-logical vocabulary. Here the basic items of the non-logical vocabulary are the propositional constants. The appropriate kind of semantic value for a proposition is a truth value, and so a model of the language consists in a free assignment of truth values to basic propositions. Two truth values are countenanced: 1 (representing truth) and 0 (representing falsity). (ii) Rules are presented which determine a truth value for every proposition of the language, given a model. The most common way of presenting these rules is via truth tables (Figure 1). Another way of stating such rules—which will be useful below—is first to introduce functions on the truth values themselves: a unary function ¬ and four binary functions ∧, ∨, → and ↔ (Figure 2).. (shrink)

In this article I try to refute the so-called "libertarian" theory of free will, and to examine how our conclusion ought to modify our common attitudes of praise and blame. In attacking the libertarian view, I shall try to show that it cannot be consistently stated. That is, my dscussion will be an "analytic-philosophic" one. I shall neglect what I think is in practice an equally powerful method of attack on the libertarian: a challenge to state his theory in such (...) a way that it will fit in the modern biology and psychology, which are becoming increasingly physicalistic. (shrink)

Friedrich Nietzsche has emerged as one of the most important and influential modern philosophers. For several decades, the book series Monographien und Texte zur Nietzsche-Forschung (MTNF) has set the agenda in a rapidly growing and changing field of Nietzsche scholarship. The scope of the series is interdisciplinary and international in orientation reflects the entire spectrum of research on Nietzsche, from philosophy to literary studies and political theory. The series publishes monographs and edited volumes that undergo a strict peer-review process. The (...) book series is led by an international team of editors, whose work represents the full range of current Nietzsche scholarship. (shrink)

Humans have long been fascinated by the idea of visiting the past and of seeing what the future will bring. Time travel has been one of the most popular themes of science fiction. Most people have seen the TV series ‘Dr Who’ or ‘Quantum Leap’ or ‘Star Trek’. You’ve probably seen one of the ‘Back to the Future’ or ‘Terminator’ movies, or ‘Twelve Monkeys’. Time travel narratives provide fascinating plots, which exercise our imaginations in ever so many ways. But is (...) the idea of travelling forward and backward in time pure fantasy—or can it be done? To be sure, not all time travel scenarios are coherent. But we hope to persuade you that the most common objections to the very idea of time travel have no real force. (shrink)