Identity Theft, Deep Brain Stimulation, and the Primacy of Post-trial Obligations.

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.

Brain injury, medical progress, and the disability paradox: Towards an Americans with Abilities Act.

It is helpful to think about the needs of patients with moderate to severe brain injury through the lens of disability law. However, there are limitations to current disability law that contribute to ongoing segregation and marginalization of individuals with severe brain injury. Indeed, one of the paradoxes of American jurisprudence is that more clear constitutional protections accrue to those who have definitively immutable conditions. Thus, as neuroscience brings new therapies to those with brain injury, they may become less protected by the constitutional elements of disability law because their conditions have changed and become mutable. This is the clinical progress that brain injury professionals all seek to achieve, but ironically these advances could potentially degrade the legal protections of patients who benefit from emerging treatments. In this paper, we will critically examine this paradox at the interface of medicine and the law and suggest that the Americans with Disabilities Act (ADA) could be nicely complemented by legislation we have named the Americans with Abilities Act (AWAA). Instead of focusing on disabilities that need protection, the AWAA seeks to sustain and foster newfound abilities made possible by the fruits of medicine and neuroscience.

Baseball and Bioethics Revisited: The Pitch Clock and Age Discrimination in a Timeless Pastime.

In this essay, the author reflects on a decade's old essay on baseball and bioethics inspired by a conversation with the late David Thomasma. In a reprise of his earlier paper, Fins worries that modernity has come to baseball with the advent of the pitch clock and that this innovation brings age discrimination to a timeless pastime.

Toward a Social Bioethics Through Interpretivism: A Framework for Healthcare Ethics.

Recent global events demonstrate that analytical frameworks to aid professionals in healthcare ethics must consider the pervasive role of social structures in the emergence of bioethical issues. To address this, the authors propose a new sociologically informed approach to healthcare ethics that they term "social bioethics." Their approach is animated by the interpretive social sciences to highlight how social structures operate vis-à-vis the everyday practices and moral reasoning of individuals, a phenomenon known as social discourse. As an exemplar, the authors use social bioethics to reframe common ethical issues in psychiatric services and discuss potential implications. Lastly, the authors discuss how social bioethics illuminates the ways healthcare ethics consultants in both policy and clinical decision-making participate in and shape broader social, political, and economic systems, which then cyclically informs the design and delivery of healthcare.

Cognitive Motor Dissociation: Gap Analysis and Future Directions.

BACKGROUND: Patients with disorders of consciousness who are behaviorally unresponsive may demonstrate volitional brain responses to motor imagery or motor commands detectable on functional magnetic resonance imaging or electroencephalography. This state of cognitive motor dissociation (CMD) may have prognostic significance. METHODS: The Neurocritical Care Society's Curing Coma Campaign identified an international group of experts who convened in a series of monthly online meetings between September 2021 and April 2023 to examine the science of CMD and identify key knowledge gaps and unmet needs. RESULTS: The group identified major knowledge gaps in CMD research: (1) lack of information about patient experiences and caregiver accounts of CMD, (2) limited epidemiological data on CMD, (3) uncertainty about underlying mechanisms of CMD, (4) methodological variability that limits testing of CMD as a biomarker for prognostication and treatment trials, (5) educational gaps for health care personnel about the incidence and potential prognostic relevance of CMD, and (6) challenges related to identification of patients with CMD who may be able to communicate using brain-computer interfaces. CONCLUSIONS: To improve the management of patients with disorders of consciousness, research efforts should address these mechanistic, epidemiological, bioengineering, and educational gaps to enable large-scale implementation of CMD assessment in clinical practice.

A Descriptive Analysis of Access to Assistive Technology in Children With Acquired Brain Injury: The Right to Assistive Devices.

OBJECTIVE: Pediatric clinicians caring for children with acquired brain injury have noted that many individuals requiring assistive technology (AT) go unserved or face delays until devices are obtained, with potential adverse implications for recovery and development. In this article we map the pathways by which AT is prescribed and assess delays and barriers to access. METHODS: We conducted a retrospective chart review of patients with moderate to severe brain injury admitted to Blythedale Children's Hospital over a 2-year period using a database drawn from the medical record. RESULTS: We identified 72 children diagnosed with brain injury requiring at least 1 device. Devices were used to improve mobility and positioning, self-care, safety, and communication, and enable access to other technologies and foster social integration. We found that 55% of devices were delivered, with most deliveries to home or the hospital's outpatient department for fitting, training, and instruction. Time to delivery ranged from 12 to 250 days with an average of 69.4 days. Twenty percent of nondeliveries were attributable to change in medical status, transfer to a skilled nursing facility, or continued inpatient status, while 31% were canceled by the family. Other nondeliveries were attributed to insurance coverage. We also found that the medical record is not designed for the longitudinal tracking of devices, indicating the need for a prospective process to document the AT trajectory. CONCLUSION: Instead of tolerating delays and denials, there should be a normative expectation that children have a right to medically necessary devices, consistent with disability law. This analysis was undertaken as a step toward formulating a prospective means of tracking AT recommendations, approvals, denials, and/or deliveries. Our findings should be understood as a promissory note toward structural reforms that are reflective of society's responsibility to better meet the needs of vulnerable children and their families.

Thalamic deep brain stimulation in traumatic brain injury: a phase 1, randomized feasibility study.

Converging evidence indicates that impairments in executive function and information-processing speed limit quality of life and social reentry after moderate-to-severe traumatic brain injury (msTBI). These deficits reflect dysfunction of frontostriatal networks for which the central lateral (CL) nucleus of the thalamus is a critical node. The primary objective of this feasibility study was to test the safety and efficacy of deep brain stimulation within the CL and the associated medial dorsal tegmental (CL/DTTm) tract.Six participants with msTBI, who were between 3 and 18 years post-injury, underwent surgery with electrode placement guided by imaging and subject-specific biophysical modeling to predict activation of the CL/DTTm tract. The primary efficacy measure was improvement in executive control indexed by processing speed on part B of the trail-making test.All six participants were safely implanted. Five participants completed the study and one was withdrawn for protocol non-compliance. Processing speed on part B of the trail-making test improved 15% to 52% from baseline, exceeding the 10% benchmark for improvement in all five cases.CL/DTTm deep brain stimulation can be safely applied and may improve executive control in patients with msTBI who are in the chronic phase of recovery.ClinicalTrials.gov identifier: NCT02881151 .

The Scholarly and Pedagogical Benefits of the Legal Laboratory: Lessons from the Consortium for the Advanced Study of Brain Injury at Yale Law School.

In our article, we share the lessons we have learned after creating and running a successful legal laboratory over the past seven years at Yale Law School. Our legal laboratory, which focuses on the intersection of law and severe brain injury, represents a unique pedagogical model for legal academia, and is closely influenced by the biomedical laboratory.

Subject and Family Perspectives from the Central Thalamic Deep Brain Stimulation Trial for Traumatic Brain Injury: Part II.

This is the second paper in a two-part series describing subject and family perspectives from the CENTURY-S (CENtral Thalamic Deep Brain Stimulation for the Treatment of Traumatic Brain InjURY-Safety) first-in-human invasive neurological device trial to achieve cognitive restoration in moderate to severe traumatic brain injury (msTBI). To participate, subjects were independently assessed to formally establish decision-making capacity to provide voluntary informed consent. Here, we report on post-operative interviews conducted after a successful trial of thalamic stimulation. All five msTBI subjects met a pre-selected primary endpoint of at least a 10% improvement in completion time on Trail-Making-Test Part B, a marker of executive function. We describe narrative responses of subjects and family members, refracted against that success. Interviews following surgery and the stimulation trial revealed the challenge of adaptation to improvements in cognitive function and emotional regulation as well as altered (and restored) relationships and family dynamics. These improvements exposed barriers to social reintegration made relevant by recoveries once thought inconceivable. The study's success sparked concerns about post-trial access to implanted devices, financing of device maintenance, battery replacement, and on-going care. Most subjects and families identified the need for supportive counseling to adapt to the new trajectory of their lives.

Daniel Callahan's Decade of Doubt.

Daniel Callahan died on July 16, 2019, just short of his 89th birthday. In the years since, we have seen the overturning of abortion rights, a concern central to his scholarship and musings about the place of religion in American civic life. Callahan's journey from lay Catholic journalist and commentator at Commonweal to a co-founder of the Hastings Center, during his decade of doubt, is especially relevant today as America revisits established precedent governing a woman's right to choose. His life-long struggle with faith and the secularization of bioethics is a story worth telling, as it may foster dialogue across a divide between religious and laical thinkers that has fractured our political discourse. We recall Callahan's misgivings about the marginalization of religious perspectives in public life; he sought not the denial of complexity nor of difference in views, but rather the importance of free and honest debate around deeply held beliefs, contextualized in the realities of the contemporary world. Callahan's ambivalence about his faith remains a part of the fabric of American life, a story that Callahan chronicled to our collective benefit for over a half-century.

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.

Prognostic humility and ethical dilemmas after severe brain injury: Summary, recommendations, and qualitative analysis of Curing Coma Campaign virtual event proceedings.

Background: Patients with severe acute brain injuries (SABI) are at risk of living with long-term disability, frequent medical complications and high rates of mortality. Determining an individual patient's prognosis and conveying this to family members/caregivers can be challenging. We conducted a webinar with experts in neurosurgery, neurocritical care, neuro-palliative care, neuro-ethics, and rehabilitation as part of the Curing Coma Campaign, which is supported by the Neurocritical Care Society. The webinar discussed topics focused on prognostic uncertainty, communicating prognosis to family members/caregivers, gaps within healthcare systems, and research infrastructure as it relates to patients experiencing SABI. The purpose of this manuscript is to describe the themes that emerged from this virtual discussion. Methods: A qualitative analysis of a webinar "Prognostic Humility and Ethical Dilemmas in Acute Brain Injury" was organized as part of the Neurocritical Care Society's Curing Coma Campaign. A multidisciplinary group of experts was invited as speakers and moderators of the webinar. The content of the webinar was transcribed verbatim. Two qualitative researchers (NK and BM) read and re-read the transcription, and familiarized themselves with the text. The two coders developed and agreed on a code book, independently coded the transcript, and discussed any discrepancies. The transcript was analyzed using inductive thematic analysis of codes and themes that emerged within the expert discussion. Results: We coded 168 qualitative excerpts within the transcript. Two main themes were discussed: (1) the concept of prognostic uncertainty in the acute setting, and (2) lack of access to and evidence for quality rehabilitation and specialized continuum of care efforts specific to coma research. Within these two main themes, we found 5 sub-themes, which were broken down into 23 unique codes. The most frequently described code was the need for clinicians to acknowledge our own uncertainties when we discuss prognosis with families, which was mentioned 13 times during the webinar. Several strategies were described for speaking with surrogates of patients who have had a severe brain injury resulting in SABI. We also identified important gaps in the United States health system and in research to improve the care of patients with severe brain injuries. Conclusion: As a result of this webinar and expert discussion, authors identified and analyzed themes related to prognostic uncertainty with SABI. Recommendations were outlined for clinicians who engage with surrogates of patients with SABI to foster informed decisions for their loved one. Finally, recommendations for changes in healthcare systems and research support are provided in order to continue to propel SABI science forward to improve future prognostic certainty.

Ethics Along the Continuum of Research Involving Persons with Disorders of Consciousness.

Interest in disorders of consciousness (DoC) has grown substantially over the past decade and has illuminated the importance of improving understanding of DoC biology; care needs (use of monitoring, performance of interventions, and provision of emotional support); treatment options to promote recovery; and outcome prediction. Exploration of these topics requires awareness of numerous ethics considerations related to rights and resources. The Curing Coma Campaign Ethics Working Group used its expertise in neurocritical care, neuropalliative care, neuroethics, neuroscience, philosophy, and research to formulate an informal review of ethics considerations along the continuum of research involving persons with DoC related to the following: (1) study design; (2) comparison of risks versus benefits; (3) selection of inclusion and exclusion criteria; (4) screening, recruitment, and enrollment; (5) consent; (6) data protection; (7) disclosure of results to surrogates and/or legally authorized representatives; (8) translation of research into practice; (9) identification and management of conflicts of interest; (10) equity and resource availability; and (11) inclusion of minors with DoC in research. Awareness of these ethics considerations when planning and performing research involving persons with DoC will ensure that the participant rights are respected while maximizing the impact and meaningfulness of the research, interpretation of outcomes, and communication of results.

Bioethics, Ukraine, and the Peril of Silence.

By considering the history of bioethics and international humanitarian law, Joseph J. Fins contends that bioethics as an academic and moral community should stand in solidarity with Ukraine as it defends freedom and civility.

José Manuel Rodríguez Delgado, Walter Freeman, and Psychosurgery: A Study in Contrasts.

History has conflated the legacies of José Manuel Rodríguez Delgado and Walter Freeman, midcentury proponents of somatic therapies for neuropsychiatric conditions. Both gained notoriety: Delgado after he appeared on the front page of the New York Times having used his stimoceiver to stop a charging bull in Spain; Freeman as the proponent of lobotomy. Both were the object of critique by the antipsychiatry movement and those who felt that their methods and objectives posed a threat to personal liberty. Using archival sources, we demonstrate that this conflation is a misrepresentation of the historical record and that their methods, objectives, ethics, and philosophical commitments differed widely. Accurate knowledge about historical antecedents is a predicate for ethical analysis and becomes especially relevant information as neuroscience develops circuit-based treatments for conditions such as Parkinson disease, depression, and brain injury. Part of that corrective is to counter the conflation of Delgado's and Freeman's life and work. Appreciating their distinctive legacies can help guide neuropsychiatric research done today that might yet haunt future generations.

Subject and Family Perspectives from the Central Thalamic Deep Brain Stimulation for Traumatic Brain Injury Study: Part I.

This is the first article in a two-part series describing subject and family perspectives from the central thalamic deep brain stimulation for the treatment of traumatic brain injury using the Medtronic PC + S first-in-human invasive neurological device trial to achieve cognitive restoration in moderate to severe traumatic brain injury, with subjects who were deemed capable of providing voluntary informed consent. In this article, we report on interviews conducted prior to surgery wherein we asked participants about their experiences recovering from brain injury and their perspectives on study enrollment and participation. We asked how risks and benefits were weighed, what their expectations and fears were, and how decisions were reached about trial participation. We found that informed consent and enrollment decisions are fraught. Subjects and families were often split, with subjects more focused on putative benefits and families concerned about incremental risk. Both subjects and families viewed brain injury as disruptive to personal identity and relationships. As decisions were made about study enrollment, families struggled with recognizing the re-emergent agency of subjects and ceding decision-making authority to subjects who had previously been dependent upon them for protection and guidance. Subjects and family members reported a hope for the relief of cognitive disabilities, improved quality of life, normalization of interpersonal interactions, and a return to work or school as reasons for study participation, along with altruism and a desire to advance science. Despite these aspirations, both subjects and families appreciated the risks of the intervention and did not suffer from a therapeutic misconception. A second essay to be published in the next issue of Cambridge Quarterly of Healthcare Ethics-Clinical Neuroethics will describe interviews conducted after surgery, the effects of cognitive restoration for subjects, families, and challenges presented to the social structures they will call upon to support them through recovery. This subsequent article will be available online prior to its formal publication in October 2023.