Perceived Barriers to Using Neurostimulation: A National Survey of Psychiatrists, Patients, Caregivers, and the General Public.

OBJECTIVES: Neurostimulation interventions often face heightened barriers limiting patient access. The objective of this study is to examine different stakeholders' perceived barriers to using different neurostimulation interventions for depression. METHODS: We administered national surveys with an embedded experiment to 4 nationwide samples of psychiatrists (n = 505), people diagnosed with depression (n = 1050), caregivers of people with depression (n = 1026), and members of the general public (n = 1022). We randomly assigned respondents to 1 of 8 conditions using a full factorial experimental design: 4 neurostimulation modalities (electroconvulsive therapy [ECT], repetitive transcranial magnetic stimulation [rTMS], deep brain stimulation [DBS], or adaptive brain implants [ABIs]) by 2 depression severity levels (moderate or severe). We asked participants to rank from a list what they perceived as the top 3 barriers to using their assigned intervention. We analyzed the data with analysis of variance and logistic regression. RESULTS: Nonclinicians most frequently reported "limited evidence of the treatment's effectiveness" and "lack of understanding of intervention" as their top 2 most important practical barriers to using ECT and TMS, respectively. Compared with nonclinicians, psychiatrists were more likely to identify "stigma about treatment" for ECT and "lack of insurance coverage" for TMS as the most important barriers. CONCLUSIONS: Overall, psychiatrists' perceptions of the most important barriers to using neurostimulation interventions were significantly different than those of nonclinicians. Perceived barriers were significantly different for implantable DBS and ABI) versus nonimplantable (rTMS and ECT) neurostimulation interventions. Better understanding of how these barriers vary by neurostimulation and stakeholder group could help us address structural and attitudinal barriers to effective use of these interventions.

Clinician preferences for neurotechnologies in pediatric drug-resistant epilepsy: A discrete choice experiment.

OBJECTIVE: Novel and minimally invasive neurotechnologies offer the potential to reduce the burden of epilepsy while avoiding the risks of conventional resective surgery. Few neurotechnologies have been tested in randomized controlled trials with pediatric populations, leaving clinicians to face decisions about whether to recommend these treatments with insufficient evidence about the relevant risks and benefits. This study specifically explores the preferences of clinicians for treating pediatric drug-resistant epilepsy (DRE) with novel neurotechnologies. METHODS: A discrete-choice experiment (DCE) was designed to elicit the preferences of clinicians with experience in treating children with DRE using novel neurotechnological interventions. The preferences for six key attributes used when making treatment decisions (chances of clinically significant improvement in seizures, major and minor risks from intervention, availability of evidence, financial burden for the family, and access to the intervention) were estimated using a conditional logit model. The estimates from this model were then used to predict the adoption of existing novel neurotechnological interventions. RESULTS: Sixty-eight clinicians completed the survey: 33 neurosurgeons, 28 neurologists, and 7 other clinicians. Most clinicians were working in the United States (74%), and the remainder (26%) in Canada. All attributes, apart from the nearest location with access to the intervention, influenced preferences significantly. The chance of clinically significant improvement in seizures was the most positive influence on clinician preferences, but low-quality evidence and a higher risk of major complications could offset these preferences. Of the existing neurotechnological interventions, vagus nerve stimulation was predicted to have the highest likelihood of adoption; deep brain stimulation had the lowest likelihood of adoption. SIGNIFICANCE: The preferences of clinicians are drive primarily by the likelihood of achieving seizure freedom for their patients, but preferences for an intervention are largely eradicated if only low quality of evidence supporting the intervention is available. Until better evidence supporting the use of potentially effective, novel neurotechnologies becomes available, clinicians are likely to prefer more established treatments.

Addressing the disparities in dementia risk, early detection and care in Latino populations: Highlights from the second Latinos & Alzheimer's Symposium.

The Alzheimer's Association hosted the second Latinos & Alzheimer's Symposium in May 2021. Due to the COVID-19 pandemic, the meeting was held online over 2 days, with virtual presentations, discussions, mentoring sessions, and posters. The Latino population in the United States is projected to have the steepest increase in Alzheimer's disease (AD) in the next 40 years, compared to other ethnic groups. Latinos have increased risk for AD and other dementias, limited access to quality care, and are severely underrepresented in AD and dementia research and clinical trials. The symposium highlighted developments in AD research with Latino populations, including advances in AD biomarkers, and novel cognitive assessments for Spanish-speaking populations, as well as the need to effectively recruit and retain Latinos in clinical research, and how best to deliver health-care services and to aid caregivers of Latinos living with AD.

They Affect the Person, but for Better or Worse? Perceptions of Electroceutical Interventions for Depression Among Psychiatrists, Patients, and the Public.

Responding to reports of cases of personality change following deep brain stimulation, neuroethicists have debated the nature and ethical implications of these changes. Recently, this literature has been challenged as being overblown and therefore potentially an impediment to patients accessing needed treatment. We interviewed 16 psychiatrists, 16 patients with depression, and 16 members of the public without depression, all from the Midwestern United States, about their views on how three electroceutical interventions (deep brain stimulation, electroconvulsive therapy, and transcranial magnetic stimulation) used to treat depression might affect the self. Participants were also asked to compare the electroceuticals' effects on the self with the effects of commonly used depression treatments (psychotherapy and pharmaceuticals). Using qualitative content analysis, we found that participants' views on electroceuticals' potential effects on the self mainly focused on treatment effectiveness and side effects. Our results have implications for both theoretical discussions in neuroethics and clinical practice in psychiatry.

Beyond the Cuckoo's Nest: Patient and Public Attitudes about Psychiatric Electroceutical Interventions.

Recent research emphasizes the role of psychiatric electroceutical interventions (PEIs), bioelectronic treatments that employ electrical stimulation to affect and modify brain function, to effectively treat psychiatric disorders. We sought to examine attitudes about three PEIs-electroconvulsive therapy, transcranial magnetic stimulation, and deep brain stimulation-among patients with depression and members of the general public. As part of a larger study to assess different stakeholders' attitudes about PEIs, we conducted semi-structured key informant interviews with 16 individuals living with depression and 16 non-depressive members of the general public. We used a purposive sampling approach to recruit potential participants based on eligibility criteria. We performed qualitative content analysis of interview transcripts. Participants from both groups expressed an overall cautionary attitude towards PEIs, yet there were mixed attitudes in both groups. Patients commonly described electroconvulsive therapy as scary, traumatic, or intense, while members of the general public often referenced the treatment's negative portrayal in One Flew over the Cuckoo's Nest. Patients and the general public saw transcranial magnetic stimulation as a potentially viable option, but in most cases only if medication was not effective. Deep brain stimulation attitudes were predominantly negative among patients and cautionary among public. The overall cautionary attitudes towards PEIs, together with the technological features and social aspects underlying those attitudes, highlight the need for unbiased education to fill the gaps in knowledge and inform perceptions of those who may benefit from these treatments.

Knowledge and Attitudes of two Latino Groups about Alzheimer Disease: a Qualitative Study.

Clustering Latinos under a single group in Alzheimer Disease (AD) research, neglects, among other things cultural and environmental differences. To address this, we examine knowledge and attitudes about AD among two Latino groups. We held 5 focus groups and 2 interviews all in Spanish with Mexicans and Puerto Ricans between 40 and 60 years old living in the Grand Rapids area in Michigan. Using content analysis of the discussions, we identified themes related to knowledge, attitudes and concerns about AD and caregiving. A total of 20 Mexicans and 9 Puerto Ricans participated. Improving knowledge and awareness, barriers and home-based family care were important themes in both Latino groups. Puerto Rican groups raised more concerns about the disease, whereas lack of knowledge was a key theme among Mexican participants. The exploratory study is a first step in promoting research that is attentive to the commonalities and differences of Latino groups and in continuing efforts to enhance health literacy among these groups.

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.

Conflicts of interest and industry professional relationships in psychiatric neurosurgery: a comparative literature review.

OBJECTIVE The research required to establish that psychiatric treatments are effective often depends on collaboration between academic clinical researchers and industry. Some of the goals of clinical practice and those of commercial developers of psychiatric therapies overlap, such as developing safe and effective treatments. However, there might also be incompatible goals; physicians aim to provide the best care they can to their patients, whereas the medical industry ultimately aims to develop therapies that are commercially successful. In some cases, however, clinical research may be aiming both at improved patient care and commercial success. It is in these cases that a conflict of interest (COI) arises. The goal of this study was to identify differences and commonalities regarding COIs between 2 kinds of somatic psychiatric interventions: pharmacological and neurosurgical. METHODS The authors conducted a study focused on professional concerns regarding pharmacological and neurosurgical psychiatric interventions. They used medical and bioethics journal articles as an indicator of professionals' concerns and carried out a thematic content analysis of peer-reviewed articles published between 1960 and 2015, using PubMed and Google Scholar. RESULTS One hundred thirty-seven relevant articles were identified, of which 86 papers focused primarily on psychopharmacology and 51 on neurosurgery. The intervention most discussed in the psychiatric neurosurgery data set was deep brain stimulation (n = 42). While there were no significant differences at the level of categories, pharmacological and neurosurgical interventions differ in the underlying themes discussed. Two issues widely discussed in the articles on pharmaceutical interventions, but largely neglected in the neurosurgery articles, were medical professional issues and industry involvement. CONCLUSIONS COIs are a neglected issue in the discussion of ethics concerns regarding medical devices in psychiatry. Yet as these interventions become more common, it is important to address them in part through learning from the discussion regarding COIs in the pharmaceutical industry and by developing approaches to address those aspects of COIs that are unique to the medical device industry.

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.

The re-emergence of psychiatric neurosurgery: insights from a cross-national study of newspaper and magazine coverage.

BACKGROUND: Surgical approaches to treat psychiatric disorders have made a comeback. News media plays an essential role in exposing the public to trends in health care such as the re-emergence of therapeutic interventions in psychiatric neurosurgery that were set aside for decades, and in shaping attitudes and acceptance to them. METHOD: We conducted an analysis of media articles covering all types of psychiatric neurosurgery published in Canada, USA, Germany, and Spain between the years 1960 and 2015. We applied both quantitative and qualitative methods to elucidate patterns of reporting for conditions, themes and tone, across geographic regions, time, and for type of intervention. RESULTS: Coverage of psychiatric neurosurgery has surged since 2001 and is largely consistent across the countries examined. It focuses on depression and deep brain stimulation, and is explicit about historical context. The tone of coverage becomes more positive for Canada, USA and Spain over time; the tone of coverage from Germany remains cautious. Identity and privacy are among the few ethical and philosophical issues raised, notably in the German press. CONCLUSIONS: The focused and optimistic attention to contemporary psychiatric neurosurgery in the media, but inattention to ethical issues, places an extra burden on functional neurosurgeons, psychiatrists, and other frontline health professionals to attend to queries from patients and policy makers about the full range of relevant emergent and emerging interventions and the mental health issues to which they may beneficially apply.

Shaking Up the Debate: Ensuring the Ethical Use of DBS Intervention Criteria for Mid-Stage Parkinson's Patients.

OBJECTIVES: Deep brain stimulation (DBS) is a well-established treatment for the management of severe motor fluctuations in advanced Parkinson's disease (PD). Until recently, device regulation, medical, and insurance practices limited DBS to patients with advanced stages of PD. In February 2016 this changed, however, when the US Food and Drug Administration (FDA) granted formal approval for the use of brain stimulator in mid-stage PD patients. In this article, we examine whether DBS in mid-stage PD can be ethically justified beyond the FDA approval. MATERIALS AND METHODS: We scrutinize the current risk-benefit profile, the costs-benefit profile, and the capacity for informed consent requirement, to ask if use of subthalamic nucleus (STN) in mid-stage DBS is ethically appropriate. RESULTS: We propose that mid-stage DBS decisions could be appropriate under a shared decision-making model, which embraces a broad quality of life perspective. CONCLUSION: Although it might be too premature to know how the FDA decision will affect medical and insurance practices, we conclude by arguing that revisions to persisting guidelines seems justified both on scientific and ethical grounds.

Pesticides.

There is growing evidence about the influence of chemical exposures on specific molecular systems and mechanisms involved in cognitive and mental function. Evidence is also emerging about the negative impact of these chemical exposures on mental health, including depression, suicide, and other risks. Despite the growing appreciation of these factors, however, little attention has been paid to the ethical and social implications of their interactions. Drawing on recent work that argues for an environmental neuroethics approach that explicitly brings together ethics, environment, and conditions of the central nervous system, this article focuses on these critical issues for pesticides specifically.

Brain matters: from environmental ethics to environmental neuroethics.

The ways in which humans affect and are affected by their environments have been studied from many different perspectives over the past decades. However, it was not until the 1970s that the discussion of the ethical relationship between humankind and the environment formalized as an academic discipline with the emergence of environmental ethics. A few decades later, environmental health emerged as a discipline focused on the assessment and regulation of environmental factors that affect living beings. Our goal here is to begin a discussion specifically about the impact of modern environmental change on biomedical and social understandings of brain and mental health, and to align this with ethical considerations. We refer to this focus as Environmental Neuroethics, offer a case study to illustrate key themes and issues, and conclude by offering a five-tier framework as a starting point of analysis.

Ethics of the electrified mind: defining issues and perspectives on the principled use of brain stimulation in medical research and clinical care.

In recent years, non-pharmacologic approaches to modifying human neural activity have gained increasing attention. One of these approaches is brain stimulation, which involves either the direct application of electrical current to structures in the nervous system or the indirect application of current by means of electromagnetic induction. Interventions that manipulate the brain have generally been regarded as having both the potential to alleviate devastating brain-related conditions and the capacity to create unforeseen and unwanted consequences. Hence, although brain stimulation techniques offer considerable benefits to society, they also raise a number of ethical concerns. In this paper we will address various dilemmas related to brain stimulation in the context of clinical practice and biomedical research. We will survey current work involving deep brain stimulation, transcranial magnetic stimulation and transcranial direct current stimulation. We will reflect upon relevant similarities and differences between them, and consider some potentially problematic issues that may arise within the framework of established principles of medical ethics: nonmaleficence and beneficence, autonomy, and justice.

Brain Data in Context: Are New Rights the Way to Mental and Brain Privacy?

The potential to collect brain data more directly, with higher resolution, and in greater amounts has heightened worries about mental and brain privacy. In order to manage the risks to individuals posed by these privacy challenges, some have suggested codifying new privacy rights, including a right to "mental privacy." In this paper, we consider these arguments and conclude that while neurotechnologies do raise significant privacy concerns, such concerns are-at least for now-no different from those raised by other well-understood data collection technologies, such as gene sequencing tools and online surveillance. To better understand the privacy stakes of brain data, we suggest the use of a conceptual framework from information ethics, Helen Nissenbaum's "contextual integrity" theory. To illustrate the importance of context, we examine neurotechnologies and the information flows they produce in three familiar contexts-healthcare and medical research, criminal justice, and consumer marketing. We argue that by emphasizing what is distinct about brain privacy issues, rather than what they share with other data privacy concerns, risks weakening broader efforts to enact more robust privacy law and policy.

The differential effects of psychiatrists' and patients' prior experiences on views about psychiatric electroceutical interventions.

The aim of this study is to examine ways in which prior experiences and familiarity with psychiatric electroceutical interventions (PEI) shape psychiatrists' and patients' views about these interventions. We administered a national survey, with an embedded experiment, to psychiatrists (n = 505) and adults diagnosed with depression (n = 1050). We randomly assigned respondents to one of 8 conditions using a full factorial experimental design: 4 PEI modalities [ECT, rTMS, DBS, or adaptive brain implants (ABIs)] by 2 depression severity levels [moderate or severe]. We analyzed the survey data with ANOVA and OLS linear regression models. Patients having experience with any PEI reported more positive affect toward, but also greater perceived risk from, their assigned PEI than did patients with no such experience. Psychiatrists who referred or administered any PEI reported more positive affect toward and greater perceived influence on self and perceived benefit from their assigned PEI than did psychiatrists with no such familiarity. Limitations of our study include that our participants were randomly assigned to a PEI, not necessarily to the one they had experience with. Moreover, our study did not directly ask about the kind of experiences participants had with a given PEI. Overall, our survey data shows that greater experience with PEIs elicits more positive affect in both stakeholder groups. Beyond this, prior PEI experience shapes attitudes towards these interventions in complex ways. Further research linking different types of experience with a given PEI would help better understand factors shaping attitudes about specific PEIs.

Proceedings of the 11th Annual Deep Brain Stimulation Think Tank: pushing the forefront of neuromodulation with functional network mapping, biomarkers for adaptive DBS, bioethical dilemmas, AI-guided neuromodulation, and translational advancements.

The Deep Brain Stimulation (DBS) Think Tank XI was held on August 9-11, 2023 in Gainesville, Florida with the theme of "Pushing the Forefront of Neuromodulation". The keynote speaker was Dr. Nico Dosenbach from Washington University in St. Louis, Missouri. He presented his research recently published in Nature inn a collaboration with Dr. Evan Gordon to identify and characterize the somato-cognitive action network (SCAN), which has redefined the motor homunculus and has led to new hypotheses about the integrative networks underpinning therapeutic DBS. The DBS Think Tank was founded in 2012 and provides an open platform where clinicians, engineers, and researchers (from industry and academia) can freely discuss current and emerging DBS technologies, as well as logistical and ethical issues facing the field. The group estimated that globally more than 263,000 DBS devices have been implanted for neurological and neuropsychiatric disorders. This year's meeting was focused on advances in the following areas: cutting-edge translational neuromodulation, cutting-edge physiology, advances in neuromodulation from Europe and Asia, neuroethical dilemmas, artificial intelligence and computational modeling, time scales in DBS for mood disorders, and advances in future neuromodulation devices.

Ethical challenges with 3D bioprinted tissues and organs.

3D Bioprinting is fast advancing to offer capabilities to process living cells into geometrically and functionally complex tissue and organ substitutes. As bioprinted constructs are making their way into clinic, the bioprinting community needs to consider the responsible innovation and translation of the bioprinted tissues and organs.

"They Are Invasive in Different Ways.": Stakeholders' Perceptions of the Invasiveness of Psychiatric Electroceutical Interventions.

Medical interventions are usually categorized as "invasive" when they involve piercing the skin or inserting an object into the body. Beyond this standard definition, however, there is little discussion of the concept of invasiveness in the medical literature, despite evidence that the term is used in ways that do not reflect the standard definition of medical invasiveness. We interviewed psychiatrists, patients with depression, and members of the public without depression to better understand their views on the invasiveness of several psychiatric electroceutical interventions (treatments that involve electrical or magnetic stimulation of the brain) for the treatment of depression. Our study shows that people recognize several kinds of invasiveness: physical, emotional, and lifestyle. In addition, several characteristics of therapies influence how invasive they are perceived to be; these include the perceived capacity of an intervention to result in harm; how localized the effects of the intervention are; the amount of control retained by the person receiving the intervention; how permanent its effects are perceived as being; and how familiar it seemed to participants. Our findings contribute to a small literature on the concept of invasiveness, which emphasizes that categorizing an intervention as invasive, or as noninvasive, evokes a variety of other normative considerations, including the potential harm it poses and how it compares to other potential therapies. It may also draw attention away from other salient features of the intervention.