Long-term Home Video EEG for Recording Clinical Events.

SUMMARY: Around 50 years after the first EEG acquisition by Hans Berger, its use in ambulatory setting was demonstrated. Ever since, ambulatory EEG has been widely available and routinely used in the United States (and to a lesser extent in Europe) for diagnosis and management of patients with epilepsy. This technology alone cannot help with semiological characterization, and absence of video is one of its main drawbacks. Addition of video to ambulatory EEG potentially improves diagnostic yield and opens new aspects of utility for better characterization of patient's events, including differential diagnosis, classification, and quantification of seizure burden. Studies evaluating quality of ambulatory video EEG (aVEEG) suggest good quality recordings are feasible. In the utilization of aVEEG, to maximize yield, it is important to consider pretest probability. Having clear pretest questions and a strong index of suspicion for focal, generalized convulsive or non-epileptic seizures further increases the usefulness of aVEEG. In this article, which is part of the topical issue "Ambulatory EEG," the authors compare long-term home aVEEG to inpatient video EEG monitoring, discuss aVEEG's use in diagnosis and follow-up of patients, and present the authors' own experience of the utility of aVEEG in a teaching hospital setting.

Ambulatory EEG Usefulness in Epilepsy Management.

SUMMARY: Long-term video-EEG monitoring has been the gold standard for diagnosis of epileptic and nonepileptic events. Medication changes, safety, and a lack of recording EEG in one's habitual environment may interfere with diagnostic representation and subsequently affect management. Some spells defy standard EEG because of ultradian and circadian times of occurrence, manifest nocturnal expression of epileptiform activity, and require classification for clarifying diagnostic input to identify optimal treatment. Some patients may be unaware of seizures, have frequent events, or subclinical seizures that require quantification before optimal management. The influence on antiseizure drug management and clinical drug research can be enlightened by long-term outpatient ambulatory EEG monitoring. With recent governmental shifts to focus on mobile health, ambulatory EEG monitoring has grown beyond diagnostic capabilities to target the dynamic effects of medical and nonmedical treatment for patients with epilepsy in their natural environment. Furthermore, newer applications in ambulatory monitoring include additional physiologic parameters (e.g., sleep, detection of myogenic signals, etc.) and extend treatment relevance to patients beyond seizure reduction alone addressing comorbid conditions. It is with this focus in mind that we direct our discussion on the present and future aspects of using ambulatory EEG monitoring in the treatment of patients with epilepsy.

Continuous Glucose Monitoring in the Hospital.

Continuous glucose monitors (CGMs) have suddenly become part of routine care in many hospitals. The coronavirus disease 2019 (COVID-19) pandemic has necessitated the use of new technologies and new processes to care for hospitalized patients, including diabetes patients. The use of CGMs to automatically and remotely supplement or replace assisted monitoring of blood glucose by bedside nurses can decrease: the amount of necessary nursing exposure to COVID-19 patients with diabetes; the amount of time required for obtaining blood glucose measurements, and the amount of personal protective equipment necessary for interacting with patients during the blood glucose testing. The United States Food and Drug Administration (FDA) is now exercising enforcement discretion and not objecting to certain factory-calibrated CGMs being used in a hospital setting, both to facilitate patient care and to obtain performance data that can be used for future regulatory submissions. CGMs can be used in the hospital to decrease the frequency of fingerstick point of care capillary blood glucose testing, decrease hyperglycemic episodes, and decrease hypoglycemic episodes. Most of the research on CGMs in the hospital has focused on their accuracy and only recently outcomes data has been reported. A hospital CGM program requires cooperation of physicians, bedside nurses, diabetes educators, and hospital administrators to appropriately select and manage patients. Processes for collecting, reviewing, storing, and responding to CGM data must be established for such a program to be successful. CGM technology is advancing and we expect that CGMs will be increasingly used in the hospital for patients with diabetes.

Digitally Enabled, Patient-Centric Clinical Trials: Shifting the Drug Development Paradigm.

The rapidly advancing field of digital health technologies provides a great opportunity to radically transform the way clinical trials are conducted and to shift the clinical trial paradigm from a site-centric to a patient-centric model. Merck's (Kenilworth, NJ) digitally enabled clinical trial initiative is focused on introduction of digital technologies into the clinical trial paradigm to reduce patient burden, improve drug adherence, provide a means of more closely engaging with the patient, and enable higher quality, faster, and more frequent data collection. This paper will describe the following four key areas of focus from Merck's digitally enabled clinical trials initiative, along with corresponding enabling technologies: (i) use of technologies that can monitor and improve drug adherence (smart dosing), (ii) collection of pharmacokinetic (PK), pharmacodynamic (PD), and biomarker samples in an outpatient setting (patient-centric sampling), (iii) use of digital devices to collect and measure physiological and behavioral data (digital biomarkers), and (iv) use of data platforms that integrate digital data streams, visualize data in real-time, and provide a means of greater patient engagement during the trial (digital platform). Furthermore, this paper will discuss the synergistic power in implementation of these approaches jointly within a trial to enable better understanding of adherence, safety, efficacy, PK, PD, and corresponding exposure-response relationships of investigational therapies as well as reduced patient burden for clinical trial participation. Obstacle and challenges to adoption and full realization of the vision of patient-centric, digitally enabled trials will also be discussed.

Past, Present and Future of Home video-electroencephalographic telemetry: A review of the development of in-home video-electroencephalographic recordings.

Video-electroencephalographic (EEG) monitoring is an essential tool in epileptology, conventionally carried out in a hospital epilepsy monitoring unit. Due to high costs and long waiting times for hospital admission, coupled with technological advances, several centers have developed and implemented video-EEG monitoring in the patient's home (home video-EEG telemetry [HVET]). Here, we review the history and current status of three general approaches to HVET: (1) supervised HVET, which entails setting up video-EEG in the patient's home with daily visiting technologist support; (2) mobile HVET (also termed ambulatory video-EEG), which entails attaching electrodes in a health care facility, supplying the patient and carers with the hardware and instructions, and then asking the patient and carer to set up recording at home without technologist support; and (3) cloud-based HVET, which adds to either of the previous models continuous streaming of video-EEG from the home to the health care provider, with the option to review data in near real time, troubleshoot hardware remotely, and interact remotely with the patient. Our experience shows that HVET can be highly cost-effective and is well received by patients. We note limitations related to long-term electrode attachment and correct camera placing while the patient is unsupervised at home, and concerns related to regulations regarding data privacy for cloud services. We believe that HVET opens significant new opportunities for research, especially in the field of understanding the many influences in seizure occurrence. We speculate that in the future HVET may merge into innovative new multisensor approaches to continuously monitoring people with epilepsy.

Brain state monitoring for the future prediction of migraine attacks.

BACKGROUND: Migraine attacks are unpredictable, precluding preemptive interventions and leading to lack of control over individuals' lives. Although there are neurophysiological changes 24-48 hours before migraine attacks, so far, they have not been used in patients' management. This study evaluates the applicability and the ability to identify pre-attack changes of daily "at home" electroencephalography obtained with a portable system for migraine patients. METHODS: Patients with episodic migraine fulfilling ICHD-3 beta criteria used a mobile system composed of a wireless EEG device (BrainStation®, Neuroverse®, Inc., USA) and mobile application (BrainVitalsM®, Neuroverse®, Inc., USA) to self-record their neural activity daily at home while resting and while performing an attention task, over the course of 2 weeks. Standard EEG spectral analysis and event-related brain potentials (ERP) methods were used and recordings were grouped by time from migraine attacks (i.e. "Interictal day", "24 h Before Migraine", "Migraine day" and "Post Migraine"). RESULTS: Twenty-four patients (22 women) recorded an average of 13.3 ± 1.9 days and had 2 ± 0.9 attacks. Twenty-four hours before attack onset, there was a statistically significant modulation of relative power in the delta (decrease) and beta (increase) frequency bands, at rest, and a significant reduction of the amplitude and inter-trial coherence measures of an attention event-related brain potential (P300). CONCLUSIONS: This proof-of-concept study shows that brain state monitoring, utilising an easy-to-use wearable EEG system to track neural modulations at home, can identify physiological changes preceding a migraine attack enabling valuable pre-symptom prediction and subsequent early intervention.

Physical activity and somatic symptoms among hemodialysis patients: a multi-center study in Zhejiang, China.

BACKGROUND: Somatic symptoms are commonly reported by patients on maintenance hemodialysis. Based on evidence that exercise can improve psychological state among the general population, we aimed to evaluate the effects of physical activity on somatic symptoms specifically in this clinical population. METHODS: This was a multicenter, cross-sectional study that included patients receiving hemodialysis treatment ≥3 times per week for > 3 months, aged 18 years or older, and who were willing to complete our study questionnaires and wear a pedometer; they were recruited from four hemodialysis centers in Zhejiang, China. Physical activity was quantified using pedometer data, with somatic symptoms quantified using the Symptom Checklist-90 (SCL-90). Hemodialysis information and blood laboratory tests were obtained from patients' medical record. The score on the somatic dimension of the SCL-90 (S1-score) subdivided into tertiles for analysis: ≤1.17 (Q1), 1.17-1.58 (Q2) and ≥ 1.58 (Q3). A multivariate logistic regression analysis was performed to estimate the crude and adjusted odd ratios (ORs) and 95% confidence intervals (CIs) for the S1- somatic score according to the physical activity level during the last week. For this analysis, patients were stratified in a high and low exercise group using a cutoff of 3000 MET-min/week. Model 1 was adjusted for skinfold thickness of the triceps, upper arm circumference, grip strength, 5-m walking time, and 30-s sit-to-stand test. In model 2, we further adjusted for the leukocyte count, high-sensitivity C-reactive protein level, and albumin level. RESULTS: After screening, 320 patients were enrolled into the study group (37.50% male, average age of 58.60 ± 14.2 years and mean average number of steps per day of 3725.92 ± 2663.47). The S1-score (1.51 ± 0.39) was significantly higher for patients than for the normal reference population (P < 0.001). As the S1-score increased, the average number of steps per day decreased, both on dialysis and non-dialysis days. Total physical activity, measured by pedometry, showed the best correlation to S1 scores (r = - 0.813; P < 0.01). The OR of a high S1-score was 1.97 [95% CI, 0.63-4.08] for patients in the low physical activity group. CONCLUSION: Higher S1 (somatic symptom) score was related to low physical activity among patients on maintenance hemodialysis.

[Wearables in the treatment of neurological diseases-where do we stand today?] / "Wearables" in der Behandlung neurologischer Erkrankungen ­ wo stehen wir heute?

Fitness and lifestyle trackers raise the awareness for wearable sensors in medical applications for clinical trials and healthcare. Various functional impairments of patients with neurological diseases are an ideal target to generate wearable-derived and patient-centered parameters that have the potential to support prevention, prediction, diagnostic procedures and therapy monitoring during the clinical work-up; however, substantial differences between clinical grade wearables and fitness trackers have to be acknowledged. For the application in clinical trials or individualized patient care distinct technical and clinical validation trials have to be conducted. The different test environments under laboratory conditions during standardized tests or under unsupervised home monitoring conditions have to be included in the algorithmic processing of sensor raw data in order to enable a clinical decision support under real-life conditions. This article presents the general understanding of the technical application for the most relevant functional impairments in neurology. While wearables used for sleep assessment have already reached a high level of technological readiness due to the defined test environment (bed, sleep), other wearable applications, e.g. for gait and mobility during home monitoring require further research in order to transfer the technical capabilities into real-life patient care.

Towards successful digital transformation through co-creation: a longitudinal study of a four-year implementation of digital monitoring technology in residential care for persons with dementia.

BACKGROUND: Implementation of digital monitoring technology systems is considered beneficial for increasing the safety and quality of care for residents in nursing homes and simultaneously improving care providers' workflow. Co-creation is a suitable approach for developing and implementing digital technologies and transforming the service accordingly. This study aimed to identify the facilitators and barriers for implementation of digital monitoring technology in residential care for persons with dementia and wandering behaviour, and explore co-creation as an implementation strategy and practice. METHODS: In this longitudinal case study, we observed and elicited the experiences of care providers and healthcare managers in eight nursing homes, in addition to those of the information technology (IT) support services and technology vendors, during a four-year implementation process. We were guided by theories on innovation, implementation and learning, as well as co-creation and design. The data were analysed deductively using a determinants of innovation framework, followed by an inductive content analysis of interview and observation data. RESULTS: The implementation represented radical innovation and required far more resources than the incremental changes anticipated by the participants. Five categories of facilitators and barriers were identified, including several subcategories for each category: 1) Pre-implementation preparations; 2) Implementation strategy; 3) Technology stability and usability; 4) Building competence and organisational learning; and 5) Service transformation and quality management. The combination of IT infrastructure instability and the reluctance of the IT support service to contribute in co-creating value with the healthcare services was the most persistent barrier. Overall, the co-creation methodology was the most prominent facilitator, resulting in a safer night monitoring service. CONCLUSION: Successful implementation of novel digital monitoring technologies in the care service is a complex and time-consuming process and even more so when the technology allows care providers to radically transform clinical practices at the point of care, which offers new affordances in the co-creation of value with their residents. From a long-term perspective, the digital transformation of municipal healthcare services requires more advanced IT competence to be integrated directly into the management and provision of healthcare and value co-creation with service users and their relatives.

Toward a new generation of smart skins.

Rapid advances in soft electronics, microfabrication technologies, miniaturization and electronic skins are facilitating the development of wearable sensor devices that are highly conformable and intimately associated with human skin. These devices-referred to as 'smart skins'-offer new opportunities in the research study of human biology, in physiological tracking for fitness and wellness applications, and in the examination and treatment of medical conditions. Over the past 12 months, electronic skins have been developed that are self-healing, intrinsically stretchable, designed into an artificial afferent nerve, and even self-powered. Greater collaboration between engineers, biologists, informaticians and clinicians will be required for smart skins to realize their full potential and attain wide adoption in a diverse range of real-world settings.

Ambulatory urodynamic monitoring: state of the art and future directions.

Urodynamic studies are a key component of the clinical evaluation of lower urinary tract dysfunction and include filling cystometry, pressure-flow studies, uroflowmetry, urethral function tests and electromyography. However, pitfalls of traditional urodynamics include physical and emotional discomfort, artificial test conditions with catheters and rapid retrograde filling of the bladder, which result in variable diagnostic accuracy. Ambulatory urodynamic monitoring (AUM) uses physiological anterograde filling and, therefore, offers a longer and more physiologically relevant evaluation. However, AUM methods rely on traditional catheters and pressure transducers and do not measure volume continuously, which is required to provide context for pressure changes. Novel telemetric AUM (TAUM) methods that use wireless, catheter-free, battery-powered devices to monitor bladder pressure and volume while patients carry out their daily activities are currently being investigated. TAUM devices under current development are innovating in the areas of remote monitoring, rechargeable energy sources, device deployment and retrieval and materials engineering to provide increased diagnostic accuracy and improved comfort for patients with incontinence or voiding dysfunction. These devices hold promise for improving the diagnosis and management of patients with lower urinary tract disorders.

Wrist-worn alcohol biosensors: Strengths, limitations, and future directions.

Wearable alcohol biosensors have emerged as a valuable tool for noninvasive, objective, and continuous monitoring of alcohol consumption. However, to date their research and clinical applications have been limited by several factors including large size, high cost, and social stigma. In contrast, recently developed wrist-worn alcohol biosensors are smaller, less expensive, and may be more acceptable for daily use. However, these devices are at the prototype phase and have just begun to be tested for research applications. In this paper, we describe our experiences with two prototypes of these new wrist-worn alcohol biosensors (i.e., Quantac Tally and BACtrack Skyn) and their associated smartphone applications in both a controlled laboratory setting and the real-world environment. Our preliminary experiences with these devices highlight their advantages including comfort, high participant acceptability, and good compliance. However, there are various limitations that should be addressed prior to future research applications of these biosensors, including large interpersonal variations in transdermal alcohol readings, lack of immediately applicable data analysis/interpretation software, and poor battery life after a few months. More research is also needed to further validate the new biosensors, and investigate individual (e.g., skin thickness, gender differences) and environmental factors (e.g., humidity, temperature) contributing to the variations in transdermal alcohol readings measured by wrist-worn alcohol biosensors.

Wearables and the medical revolution.

Wearable sensors are already impacting healthcare and medicine by enabling health monitoring outside of the clinic and prediction of health events. This paper reviews current and prospective wearable technologies and their progress toward clinical application. We describe technologies underlying common, commercially available wearable sensors and early-stage devices and outline research, when available, to support the use of these devices in healthcare. We cover applications in the following health areas: metabolic, cardiovascular and gastrointestinal monitoring; sleep, neurology, movement disorders and mental health; maternal, pre- and neo-natal care; and pulmonary health and environmental exposures. Finally, we discuss challenges associated with the adoption of wearable sensors in the current healthcare ecosystem and discuss areas for future research and development.

Seizure prediction - ready for a new era.

Epilepsy is a common disorder characterized by recurrent seizures. An overwhelming majority of people with epilepsy regard the unpredictability of seizures as a major issue. More than 30 years of international effort have been devoted to the prediction of seizures, aiming to remove the burden of unpredictability and to couple novel, time-specific treatment to seizure prediction technology. A highly influential review published in 2007 concluded that insufficient evidence indicated that seizures could be predicted. Since then, several advances have been made, including successful prospective seizure prediction using intracranial EEG in a small number of people in a trial of a real-time seizure prediction device. In this Review, we examine advances in the field, including EEG databases, seizure prediction competitions, the prospective trial mentioned and advances in our understanding of the mechanisms of seizures. We argue that these advances, together with statistical evaluations, set the stage for a resurgence in efforts towards the development of seizure prediction methodologies. We propose new avenues of investigation involving a synergy between mechanisms, models, data, devices and algorithms and refine the existing guidelines for the development of seizure prediction technology to instigate development of a solution that removes the burden of the unpredictability of seizures.

Future of Smart Cardiovascular Implants.

Cardiovascular disease remains the leading cause of death in Western society. Recent technological advances have opened the opportunity of developing new and innovative smart stent devices that have advanced electrical properties that can improve diagnosis and even treatment of previously intractable conditions, such as central line access failure, atherosclerosis and reporting on vascular grafts for renal dialysis. Here we review the latest advances in the field of cardiovascular medical implants, providing a broad overview of the application of their use in the context of cardiovascular disease rather than an in-depth analysis of the current state of the art. We cover their powering, communication and the challenges faced in their fabrication. We focus specifically on those devices required to maintain vascular access such as ones used to treat arterial disease, a major source of heart attacks and strokes. We look forward to advances in these technologies in the future and their implementation to improve the human condition.

Teleneurology and mobile technologies: the future of neurological care.

Neurological disorders are the leading cause of global disability. However, for most people around the world, current neurological care is poor. In low-income countries, most individuals lack access to proper neurological care, and in high-income countries, distance and disability limit access. With the global proliferation of smartphones, teleneurology - the use of technology to provide neurological care and education remotely - has the potential to improve and increase access to care for billions of people. Telestroke has already fulfilled this promise, but teleneurology applications for chronic conditions are still in their infancy. Similarly, few studies have explored the capabilities of mobile technologies such as smartphones and wearable sensors, which can guide care by providing objective, frequent, real-world assessments of patients. In low-income settings, teleneurology can increase the capacity of local care systems through professional development, diagnostic support and consultative services. In high-income settings, teleneurology is likely to promote the expansion and migration of neurological care away from institutions, incorporate systems of asynchronous communication (such as e-mail), integrate clinicians with diverse skill sets and reach new populations. Inertia, outdated policies and social barriers - especially the digital divide - will slow this progress at considerable cost. However, a future increasingly will be possible in which neurological care can be accessed by anyone, anywhere. Here, we examine the emerging evidence regarding the benefits of teleneurology for chronic conditions, its role and risks in low-income countries and the promise of mobile technologies to measure disease status and deliver care. We conclude by discussing the future trends, barriers and timing for the adoption of teleneurology.

The effectiveness of remote monitoring of elderly patients after hospitalisation for heart failure: The renewing health European project.

Background: The effectiveness of remote monitoring (RM) in the management of the elderly after hospitalisation for heart failure (HF) is uncertain. Methods and results: Randomized trial (2:1 design) comparing RM with usual care (UC) in patients >65 years old, hospitalised in the previous 3 months for HF with left ventricular ejection fraction <40% or >40% plus BNP > 400 (or NT-proBNP >1500); the primary end-point (PE) was the combined 12-month incidence of death by any cause or at least one hospital readmission for HF. Overall, 229 and 110 pts were enrolled in the RM and UC group, respectively; in the intention-to-treat analysis, the PE was reached in 101 (44.1%) and 51 (46.4%) patients in the RM and UC group respectively (p = 0.78), with no difference in mortality (24.0% vs 21.8%, p = 0.097) or in the proportion of patients with at least one rehospitalisation for HF (34.5% vs 39.1%, p = 0.48). Quality of life, secondary end-point measured by SF36v2 scores, was significantly improved in the RM group, both in physical (2.63 score difference, p < 0.0001) and mental (1.69 score difference, p = 0.04) components. In the on-treatment analysis comparing 190 patients that ultimately received RM with the 149 remaining patients, the primary end-point was reached in 40.0% vs 51.0% (p = 0.055), respectively. Conclusion: In the intention-to-treat analysis, during the 12-month follow up of elderly patients hospitalised for HF, remote monitoring had no impact on the primary end-point but it significantly improved patients' quality of life. In the on-treatment analysis a trend for improving the PE was observed in the RM group.