Definition of Implanted Neurological Device Abandonment: A Systematic Review and Consensus Statement.

Importance: Establishing a formal definition for neurological device abandonment has the potential to reduce or to prevent the occurrence of this abandonment. Objective: To perform a systematic review of the literature and develop an expert consensus definition for neurological device abandonment. Evidence Review: After a Royal Society Summit on Neural Interfaces (September 13-14, 2023), a systematic English language review using PubMed was undertaken to investigate extant definitions of neurological device abandonment. Articles were reviewed for relevance to neurological device abandonment in the setting of deep brain, vagal nerve, and spinal cord stimulation. This review was followed by the convening of an expert consensus group of physicians, scientists, ethicists, and stakeholders. The group summarized findings, added subject matter experience, and applied relevant ethics concepts to propose a current operational definition of neurological device abandonment. Data collection, study, and consensus development were done between September 13, 2023, and February 1, 2024. Findings: The PubMed search revealed 734 total articles, and after review, 7 articles were found to address neurological device abandonment. The expert consensus group addressed findings as germane to neurological device abandonment and added personal experience and additional relevant peer-reviewed articles, addressed stakeholders' respective responsibilities, and operationally defined abandonment in the context of implantable neurotechnological devices. The group further addressed whether clinical trial failure or shelving of devices would constitute or be associated with abandonment as defined. Referential to these domains and dimensions, the group proposed a standardized definition for abandonment of active implantable neurotechnological devices. Conclusions and Relevance: This study's consensus statement suggests that the definition for neurological device abandonment should entail failure to provide fundamental aspects of patient consent; fulfill reasonable responsibility for medical, technical, or financial support prior to the end of the device's labeled lifetime; and address any or all immediate needs that may result in safety concerns or device ineffectiveness and that the definition of abandonment associated with the failure of a research trial should be contingent on specific circumstances.

Corrigendum: Does personality change follow deep brain stimulation in Parkinson's disease patients?

[This corrects the article DOI: 10.3389/fpsyg.2021.643277.].

Future directions in psychiatric neurosurgery: Proceedings of the 2022 American Society for Stereotactic and Functional Neurosurgery meeting on surgical neuromodulation for psychiatric disorders.

OBJECTIVE: Despite advances in the treatment of psychiatric diseases, currently available therapies do not provide sufficient and durable relief for as many as 30-40% of patients. Neuromodulation, including deep brain stimulation (DBS), has emerged as a potential therapy for persistent disabling disease, however it has not yet gained widespread adoption. In 2016, the American Society for Stereotactic and Functional Neurosurgery (ASSFN) convened a meeting with leaders in the field to discuss a roadmap for the path forward. A follow-up meeting in 2022 aimed to review the current state of the field and to identify critical barriers and milestones for progress. DESIGN: The ASSFN convened a meeting on June 3, 2022 in Atlanta, Georgia and included leaders from the fields of neurology, neurosurgery, and psychiatry along with colleagues from industry, government, ethics, and law. The goal was to review the current state of the field, assess for advances or setbacks in the interim six years, and suggest a future path forward. The participants focused on five areas of interest: interdisciplinary engagement, regulatory pathways and trial design, disease biomarkers, ethics of psychiatric surgery, and resource allocation/prioritization. The proceedings are summarized here. CONCLUSION: The field of surgical psychiatry has made significant progress since our last expert meeting. Although weakness and threats to the development of novel surgical therapies exist, the identified strengths and opportunities promise to move the field through methodically rigorous and biologically-based approaches. The experts agree that ethics, law, patient engagement, and multidisciplinary teams will be critical to any potential growth in this area.

Proceedings of the 10th annual deep brain stimulation think tank: Advances in cutting edge technologies, artificial intelligence, neuromodulation, neuroethics, interventional psychiatry, and women in neuromodulation.

The deep brain stimulation (DBS) Think Tank X was held on August 17-19, 2022 in Orlando FL. The session organizers and moderators were all women with the theme women in neuromodulation. Dr. Helen Mayberg from Mt. Sinai, NY was the keynote speaker. She discussed milestones and her experiences in developing depression 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 the logistical and ethical issues facing the field. The consensus among the DBS Think Tank X speakers was that DBS has continued to expand in scope however several indications have reached the "trough of disillusionment." DBS for depression was considered as "re-emerging" and approaching a slope of enlightenment. DBS for depression will soon re-enter clinical trials. The group estimated that globally more than 244,000 DBS devices have been implanted for neurological and neuropsychiatric disorders. This year's meeting was focused on advances in the following areas: neuromodulation in Europe, Asia, and Australia; cutting-edge technologies, closed loop DBS, DBS tele-health, neuroethics, lesion therapy, interventional psychiatry, and adaptive DBS.

Does Personality Change Follow Deep Brain Stimulation in Parkinson's Disease Patients?

Deep Brain Stimulation (DBS) has emerged as a safe, effective, and appealing treatment for Parkinson's Disease (PD), particularly for improving motor symptoms (e. g., tremor, bradykinesia, and rigidity). However, concerns have been raised about whether DBS causes psychological changes, including changes to personality: characteristic and relatively stable patterns of affect, behavior, cognition, and desire. In this article, after first presenting some background information about PD and DBS, we examined evidence obtained from various empirical research methods (quantitative, qualitative, and mixed methods for evaluating patient valued characteristics) pertaining to whether DBS causes personality change. General limitations across research methods include a lack of randomized clinical trials and small sample sizes. We organized our review of findings according to different layers of personality variables: dispositional traits (including personality pathology), characteristic adaptations, and narrative identity. Though most work has been done on dispositional traits, there is not much evidence that dispositional traits change following DBS. Little work has been done on characteristic adaptations, but there is somewhat consistent evidence for positive perceived progress toward goals across a number of domains: routine activities, work, social/relational, and leisure. Nascent work on narrative identity holds promise for revealing issues around self-image that may be common following DBS. We listed a number of strategies for advancing research, highlighting opportunities related to personality conceptualization, personality assessment, and interdisciplinary scholarship. Finally, we offer practical applications of our findings for the informed consent process and for ongoing treatment.

Double blind randomized controlled trial of deep brain stimulation for obsessive-compulsive disorder: Clinical trial design.

Obsessive-compulsive disorder (OCD), a leading cause of disability, affects ~1-2% of the population, and can be distressing and disabling. About 1/3 of individuals demonstrate poor responsiveness to conventional treatments. A small proportion of these individuals may be deep brain stimulation (DBS) candidates. Candidacy is assessed through a multidisciplinary process including assessment of illness severity, chronicity, and functional impact. Optimization failure, despite multiple treatments, is critical during screening. Few patients nationwide are eligible for OCD DBS and thus a multi-center approach was necessary to obtain adequate sample size. The study was conducted over a six-year period and was a NIH-funded, eight-center sham-controlled trial of DBS targeting the ventral capsule/ventral striatum (VC/VS) region. There were 269 individuals who initially contacted the sites, in order to achieve 27 participants enrolled. Study enrollment required extensive review for eligibility, which was overseen by an independent advisory board. Disabling OCD had to be persistent for ≥5 years despite exhaustive medication and behavioral treatment. The final cohort was derived from a detailed consent process that included consent monitoring. Mean illness duration was 27.2 years. OCD symptom subtypes and psychiatric comorbidities varied, but all had severe disability with impaired quality of life and functioning. Participants were randomized to receive sham or active DBS for three months. Following this period, all participants received active DBS. Treatment assignment was masked to participants and raters and assessments were blinded. The final sample was consistent in demographic characteristics and clinical features when compared to other contemporary published prospective studies of OCD DBS. We report the clinical trial design, methods, and general demographics of this OCD DBS sample.

Changes in Patients' Desired Control of Their Deep Brain Stimulation and Subjective Global Control Over the Course of Deep Brain Stimulation.

Objective: To examine changes in patients' desired control of the deep brain stimulator (DBS) and perception of global life control throughout DBS. Methods: A consecutive cohort of 52 patients with Parkinson's disease (PD) was recruited to participate in a prospective longitudinal study over three assessment points (pre-surgery, post-surgery months 3 and 6). Semi-structured interviews assessing participants' desire for stimulation control and perception of global control were conducted at all three points. Qualitative data were coded using content analysis. Visual analog scales were embedded in the interviews to quantify participants' perceptions of control over time. Results: Participants reported significant increases in their perception of global control over time and significant declines in their desired control of the stimulation. These changes were unrelated to improvements in motor symptoms. Improvements in global control were negatively correlated with a decline in desired stimulation control. Qualitative data indicate that participants have changed, nuanced levels of desired control over their stimulators. Increased global life control following DBS may be attributed to increased control over PD symptoms, increased ability to engage in valued activities, and increased overall self-regulation, while other domains related to global control remained unaffected by DBS. Conclusions: There are few empirical data documenting patients' desire for stimulation control throughout neuromodulation and how stimulation control is related to other aspects of control despite the growing application of neuromodulation devices to treat a variety of disorders. Our data highlight distinctions in different types of control and have implications for the development of patient-controlled neurostimulation devices.

Proceedings of the Seventh Annual Deep Brain Stimulation Think Tank: Advances in Neurophysiology, Adaptive DBS, Virtual Reality, Neuroethics and Technology.

The Seventh Annual Deep Brain Stimulation (DBS) Think Tank held on September 8th of 2019 addressed the most current: (1) use and utility of complex neurophysiological signals for development of adaptive neurostimulation to improve clinical outcomes; (2) Advancements in recent neuromodulation techniques to treat neuropsychiatric disorders; (3) New developments in optogenetics and DBS; (4) The use of augmented Virtual reality (VR) and neuromodulation; (5) commercially available technologies; and (6) ethical issues arising in and from research and use of DBS. These advances serve as both "markers of progress" and challenges and opportunities for ongoing address, engagement, and deliberation as we move to improve the functional capabilities and translational value of DBS. It is in this light that these proceedings are presented to inform the field and initiate ongoing discourse. As consistent with the intent, and spirit of this, and prior DBS Think Tanks, the overarching goal is to continue to develop multidisciplinary collaborations to rapidly advance the field and ultimately improve patient outcomes.

An iPad-based Measure of Processing Speed in Older Adults Hospitalized for Heart Failure.

BACKGROUND: In older adults hospitalized with heart failure (HF), cognitive impairment is associated with increased hospital readmission and mortality risk. There is no consensus on an objective, scalable method of cognitive screening in this population. OBJECTIVE: The aim of this project was to determine the feasibility, test-retest reliability, and convergent validity of the Processing Speed Test (PST), a test of information processing, attention, and working memory administered on an iPad in older adults hospitalized with HF. METHODS: Patients hospitalized with HF (n = 30) and age-, sex-, and education-matched controls (n = 30) participated in the study. To determine test-retest reliability, the PST was administered on an iPad on 2 occasions, separated by 12 to 48 hours. The Symbol Digit Modalities Test was administered at the first testing time point to determine convergent validity. RESULTS: Test-retest reliability of the PST was 0.80 and 0.92 in individuals with HF and controls, respectively. Convergent validity was 0.72 and 0.90 for individuals with HF and controls, respectively. Time to complete the PST was similar for both individuals with HF and controls (<5 minutes). CONCLUSION: The iPad-based deployment of the PST was a feasible, reliable, and valid cognitive screen for older adults hospitalized with HF. Using a tablet-based self-administered cognitive screen in older adults with HF provides a method of cognitive assessment that is amenable to widespread clinical utilization.

Iowa Gambling Task Performance in Parkinson Disease Patients with Impulse Control Disorders.

OBJECTIVE: A subgroup of patients with Parkinson disease (PD) develops impulse control disorders (ICD) associated with their dopamine replacement therapy. Patients and their families may be reluctant to report ICD symptoms or unaware these symptoms are related to PD medication, which can make detecting an ICD difficult for clinicians. Ideally, a behavioral measure that is sensitive to ICD could be employed to ensure that patients with these behaviors are identified and treated. The Iowa Gambling Task (IGT), a standardized decision-making task, has proven sensitive in other populations with impulse control problems. We hypothesized that the IGT would differentiate between PD patients with and without ICD. METHODS: We compared IGT performance and disease variables in 24 PD patients with ICD and 24 PD patients without ICD. Patient groups were matched in terms of age, sex, and duration of PD. RESULTS: There were no significant differences in IGT scores between PD groups. IGT performance declined with increasing age, but the majority of patients performed within normal limits based on published age- and education-corrected normative data. CONCLUSIONS: The IGT did not distinguish between PD patients with and without ICD. Increasing age negatively impacted performance in both groups. Other studies have found that IGT performance may decline in normal aging. Our results suggest that the IGT lacks the sensitivity and specificity needed to differentiate between age-related deficits and disruption in frontal-subcortical circuits underlying ICD associated with PD medications. Therefore, the IGT is not an appropriate behavioral measure for ICD in PD patients.

Pragmatism and the Importance of Interdisciplinary Teams in Investigating Personality Changes following DBS.

Gilbert and colleagues (2018) point out the discrepancy between the limited empirical data illustrating changes in personality (and related concepts of identity, agency, authenticity, autonomy, and self, i.e., PIAAAS) following implantation of deep brain stimulating (DBS) electrodes and the vast number of conceptual neuroethics papers implying that these changes are widespread, deleterious, and clinically significant. Their findings are reminiscent of C. P. Snow's essay on the divide between the two cultures of the humanities (representing the conceptual publications) and the sciences (representing the empirical work). This division in the literature raises significant ethical concerns surrounding unjustified fear of personality changes in the context of DBS and negative perceptions of clinician-scientists engaged in DBS. These concerns have real world implications for funding future innovative, DBS trials aimed to reduce suffering as well as hampering true interdisciplinary scholarship. We argue that the philosophical tradition of pragmatism and the value it places on empirical inquiry, experiential knowledge, and inter-disciplinary scholarship - reflecting diverse ways of knowing - provides a framework to start to address the important questions Gilbert and colleagues raise. In particular, we highlight the importance of expert clinician knowledge in contributing to the neuroethical questions raised by Gilbert and colleagues. Finally, we provide illustrative examples of some of our interdisciplinary empirical research that demonstrate the iterative cycle of inquiry characteristic of pragmatism in which conceptual neuroethics questions have led to empirical studies whose results then raise additional conceptual questions that give rise to new empirical studies in a way that highlights the contributions of the humanities and the sciences.

Validation of computerized episodic memory measures in a diverse clinical sample referred for neuropsychological assessment.

OBJECTIVE: To examine the convergent and discriminant validity of two brief computerized episodic memory measures in a large, diverse clinical sample of adults undergoing neuropsychological assessment. METHOD: Computerized measures of word and face memory were administered to 233 adults (age 30 and over) who also completed comprehensive neuropsychological testing. RESULTS: Moderate correlations were observed between the computerized memory tests and a wide range of traditional neuropsychological measures of episodic memory (e.g. word-list learning, story recall, face recognition, design recall). Select measures of visuomotor processing speed and language were also related to performance on the computerized tasks. In contrast, the computerized memory tests showed weak correlations with tests in other cognitive domains (i.e. visuospatial skills, attention/working memory, executive function, motor dexterity, academic skills) and self-report screening measures of mood and anxiety. Similar to traditional measures of episodic memory, the computerized memory measures were sensitive to effects of age and gender. CONCLUSIONS: Computerized measures of word and face memory showed good convergent and discriminant validity in this diverse clinical sample supporting the construct validity of these measures. This indicates that it may be feasible to measure memory function in clinical settings using brief, well-designed computerized memory measures.

Patients' shifting goals for deep brain stimulation and informed consent.

OBJECTIVE: To determine using a repeated-measures, prospective design whether deep brain stimulation (DBS) results in changes in the importance of symptom and behavioral goals individually identified by patients with Parkinson disease (PD) before DBS surgery. METHODS: Fifty-two participants recruited from a consecutive series completed a semistructured interview soliciting their rank-ordered symptom and behavioral goals and corresponding visual analog scales measuring perceived symptom severity and limits to goal attainment. Rank orders were reassessed at 2 times after DBS. Changes in rank order over time were examined with χ2 analyses. The relationships between change in symptom severity/limits to behavioral goal attainment and change in rank order were examined with mixed-effects linear regression models. RESULTS: Most participants changed the rank order of their symptom (81%) and behavioral (77%) goals 3 months after DBS surgery. Change in rank order of symptom goals was significantly related to change in severity ratings such that improvements in self-reported symptom severity were associated with reductions in rank. In contrast, no such relationship was evident for the behavioral goals. CONCLUSION: These data illustrate how patients' primary goals for DBS shift early in stimulation and highlight the important differences between symptom and behavioral goals. Changes in the rank order of symptom goals were related to changes in symptom severity, whereas subtler shifts in behavioral goals were unrelated to improvements after DBS. This observation suggests that DBS does not affect goals that may be more reflective of core personal values. The findings provide empiric data that can help improve the informed consent process.

The Role of a Neuropsychologist on a Movement Disorders Deep Brain Stimulation Team.

The term movement disorders is misleading in the implication that the symptoms are limited to motor problems. Most movement disorders include a variety of neurobehavioral and neurocognitive symptoms that require neuropsychological expertise. The goal of this paper is to provide a rationale and practical roadmap for neuropsychologists' involvement in a Movement Disorders team with a specific focus on pre-operative deep brain stimulation (DBS) evaluations. Pragmatic recommendations regarding requisite skills, clinical practice, recommendations, communication, and benefits are outlined.

Who does she think she is? Women, leadership and the 'B'(ias) word.

OBJECTIVE: Despite the increasing number of women in professional fields, women are under-represented in leadership roles. The goal of this paper is to identify potential explanations for the gender gap in leadership. METHOD: The academic literature with respect to gender roles, leadership, and organizational expectations; gender differences in leadership; and the potential role of second generation bias was reviewed. RESULTS: Women are as effective as male leaders in a variety of organizational settings. The role congruity theory suggests that women are placed in a double bind: maintenance of their gender role may result in a failure to meet the requirements of a leader role whereas conforming to a leader role may result in the failure to conform to their gender role. Second generation, or implicit, bias also influences women's leadership opportunities. This is further complicated by expectations that women will engage in more altruistic organizational citizenship behaviors or be penalized. CONCLUSION: Differences in ability do not account for the gender gap in leadership. Cultural factors, including gender role and leadership expectations, organizational demands, and second-generation bias impact women's ability to lead. Pragmatic recommendations to increase women's influence and representation in leadership are provided.

Clinical Ethics in the Context of Deep Brain Stimulation for Movement Disorders.

OBJECTIVE: Discuss common clinical ethical challenges encountered in working with patients who are candidates for deep brain stimulation (DBS) for the treatment of motor symptoms of Parkinson's disease (PD). METHOD: The relevant literature is reviewed and supplemented by descriptive, ethically challenging cases stemming from decades of combined experience working on DBS teams. We outline ethical arguments and provide pragmatic recommendations to assist neuropsychologists working in movement disorder teams. RESULTS: The goals of the pre-operative neuropsychological DBS assessment include: (1) identification of potential cognitive risk factors; (2) identification of relevant neuropsychiatric or neurobehavioral factors; (3) assessment of level of family support; and (4) systematic assessment of patient's and family member's goals or expectations for DBS. The information gleaned from the pre-operative neuropsychological assessment is highly relevant to the most commonly studied clinical ethics challenges encountered in DBS: (1) assessment of risk/benefit; (2) determinations regarding inclusion/exclusion; (3) autonomy; and (4) patient's perception of benefit and quality of life. CONCLUSIONS: Neuropsychologists are particularly well poised to provide unique and important insights to assist with developing the most ethically sound practices that take into account patient's values as well as fiduciary responsibilities to the patient, the team, the profession, and the broader community.

Randomized clinical trial of deep brain stimulation for poststroke pain.

OBJECTIVE: The experience with deep brain stimulation (DBS) for pain is largely based on uncontrolled studies targeting the somatosensory pathways, with mixed results. We hypothesized that targeting limbic neural pathways would modulate the affective sphere of pain and alleviate suffering. METHODS: We conducted a prospective, double-blinded, randomized, placebo-controlled, crossover study of DBS targeting the ventral striatum/anterior limb of the internal capsule (VS/ALIC) in 10 patients with poststroke pain syndrome. One month after bilateral DBS, patients were randomized to active DBS or sham for 3 months, followed by crossover for another 3-month period. The primary endpoint was a ≥50% improvement on the Pain Disability Index in 50% of patients with active DBS compared to sham. This 6-month blinded phase was followed by an 18-month open stimulation phase. RESULTS: Nine participants completed randomization. Although this trial was negative for its primary and secondary endpoints, we did observe significant differences in multiple outcome measures related to the affective sphere of pain (eg, Montgomery-Åsberg Depression Rating Scale, Beck Depression Inventory, Affective Pain Rating Index of the Short-Form McGill Pain Questionnaire). Fourteen serious adverse events were recorded and resolved. INTERPRETATION: VS/ALIC DBS to modulate the affective sphere of pain represents a paradigm shift in chronic pain management. Although this exploratory study was negative for its primary endpoint, VS/ALIC DBS demonstrated an acceptable safety profile and statistically significant improvements on multiple outcome measures related to the affective sphere of pain. Therefore, we believe these results justify further work on neuromodulation therapies targeting the affective sphere of pain. Ann Neurol 2017;81:653-663.

Being open minded about neuromodulation trials: Finding success in our "failures".

As part of the efforts of a multi-disciplinary, international working group focused on ethical issues in neuromodulation for neuro-psychiatric disorders, we propose a novel; strategy for study design which iteratively applies new knowledge to on-going and future trials. Under current practice, device studies may be closed or categorized as "failures" before knowledge embedded in them can be fully mined. We propose the use of an iterative process to gain knowledge from subjects who have responded to those who have not. This approach can help maximize outcomes in non-responders and inform the design of future studies. This more agile yet rigorous methodology leverages information at all stages of investigation and promotes both scientific discovery and; stewardship.

Insights gleaned by measuring patients' stated goals for DBS: More than tremor.

OBJECTIVE: To report prospective repeated measures data detailing the perceived benefit of deep brain stimulation (DBS) on the most commonly cited symptom and activity goals identified by patients with Parkinson disease. METHODS: Fifty-two participants were recruited from a consecutive series. Participants completed a semi-structured interview soliciting their symptom and behavioral goals and corresponding visual analog scales measuring perceived symptom severity and limits to goal attainment. Severity ratings were completed prior to and at 2 times following DBS. Changes in severity over time were assessed using a mixed effects linear model. The pattern of relationships between the severity ratings and standard clinical research (SCR) measures routinely administered were examined using Pearson correlations. RESULTS: The most common symptom goals were improvements in tremor, gait, and nonmotor symptoms, whereas the most frequent behavioral goals related to interpersonal relationships, work, and avocational pursuits. Most severity ratings were significantly correlated with each other but not with the SCR measures. Significant improvements were evident on all SCR measures after DBS. Participants' severity ratings for their symptom and behavioral goals improved significantly over time although not all severity ratings changed in the same manner. CONCLUSIONS: These data illustrate that improvements in participants' individually defined goals were evident over time and that some of these improvements occurred in areas in which the benefits associated with DBS are not as well-documented. The participants' severity ratings were not redundant with SCR measures, suggesting that novel and potentially important information can be gleaned by systematically assessing patients' goals.