Use of nonintrusive sensor-based information and communication technology for real-world evidence for clinical trials in dementia

Cognitive function is an important end point of treatments in dementia clinical trials. Measuring cognitive function by standardized tests, however, is biased toward highly constrained environments (such as hospitals) in selected samples. Patient-powered real-world evidence using information and communication technology devices, including environmental and wearable sensors, may help to overcome these limitations. This position paper describes current and novel information and communication technology devices and algorithms to monitor behavior and function in people with prodromal and manifest stages of dementia continuously, and discusses clinical, technological, ethical, regulatory, and user-centered requirements for collecting real-world evidence in future randomized controlled trials. Challenges of data safety, quality, and privacy and regulatory requirements need to be addressed by future smart sensor technologies. When these requirements are satisfied, these technologies will provide access to truly user relevant outcomes and broader cohorts of participants than currently sampled in clinical trials

Early diagnosis of disorders based on behavioural shifts and biomedical signals

There are many disorders that directly affect people’s behaviour. The people that are suffering from such a disorder are not aware of their situation, and too often the disorders are identified by relatives or co-workers because they notice behavioural shifts. However, when these changes become noticeable, it is often too late and irreversible damages have already been produced. Early detection is the key to prevent severe health-related damages and healthcare costs, as well as to improve people’s quality of life. Nowadays, in full swing of ubiquitous computing paradigm, users’ behaviour patterns can be unobtrusively monitored by means of interactions with many electronic devices. The application of this technology for the problem at hand would lead to the development of systems that are able to monitor disorders’ onset and progress in an ubiquitous and unobtrusive way, thus enabling their early detection. Some attempts for the detection of specific disorders based on these technologies have been proposed, but a global methodology that could be useful for the early detection of a wide range of disorders is still missing. This thesis aims to fill that gap by presenting as main contribution a global screening methodology for the early detection of disorders based on unobtrusive monitoring of physiological and behavioural data. The proposed methodology is the result of a cross-case analysis between two individual validation scenarios: stress in the workplace and Alzheimer’s Disease (AD) at home, from which conclusions that contribute to each of the two research fields have been drawn. The analysis of similarities and differences between the two case studies has led to a complete and generalized definition of the steps to be taken for the detection of a new disorder based on ubiquitous computing.Jendearen portaeran eragin zuzena duten gaixotasun ugari daude. Hala ere, askotan, gaixotasuna pairatzen duten pertsonak ez dira euren egoerataz ohartzen, eta familiarteko edo lankideek identifikatu ohi dute berau jokabide aldaketetaz ohartzean. Portaera aldaketa hauek nabarmentzean, ordea, beranduegi izan ohi da eta atzerazeinak diren kalteak eraginda egon ohi dira. Osasun kalte larriak eta gehiegizko kostuak ekiditeko eta gaixoen bizi kalitatea hobetzeko gakoa, gaixotasuna garaiz detektatzea da. Gaur egun, etengabe zabaltzen ari den Nonahiko Konputazioaren paradigmari esker, erabiltzaileen portaera ereduak era diskretu batean monitorizatu daitezke, gailu teknologikoekin izandako interakzioari esker. Eskuartean dugun arazoari konponbidea emateko teknologi hau erabiltzeak gaixotasunen sorrera eta aurrerapena nonahi eta era diskretu batean monitorizatzeko gai diren sistemak garatzea ekarriko luke, hauek garaiz hautematea ahalbidetuz. Gaixotasun konkretu batzuentzat soluzioak proposatu izan dira teknologi honetan oinarrituz, baina metodologia orokor bat, gaixotasun sorta zabal baten detekzio goiztiarrerako erabilgarria izango dena, oraindik ez da aurkeztu. Tesi honek hutsune hori betetzea du helburu, mota honetako gaixotasunak garaiz hautemateko, era diskretu batean atzitutako datu fisiologiko eta konportamentalen erabileran oinarritzen den behaketa sistema orokor bat proposatuz. Proposatutako metodologia bi balidazio egoera desberdinen arteko analisi gurutzatu baten emaitza da: estresa lantokian eta Alzheimerra etxean, balidazio egoera bakoitzari dagozkion ekarpenak ere ondorioztatu ahal izan direlarik. Bi kasuen arteko antzekotasun eta desberdintasunen analisiak, gaixotasun berri bat nonahiko konputazioan oinarrituta detektatzeko jarraitu beharreko pausoak bere osotasunean eta era orokor batean definitzea ahalbidetu du

Digital phenotyping by wearable-driven artificial intelligence in older adults and people with Parkinson's disease: Protocol of the mixed method, cyclic ActiveAgeing study

This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.Background: Active ageing is described as the process of optimizing health, empowerment, and security to enhance the quality of life in the rapidly growing population of older adults. Meanwhile, multimorbidity and neurological disorders, such as Parkinson’s disease (PD), lead to global public health and resource limitations. We introduce a novel user-centered paradigm of ageing based on wearable-driven artificial intelligence (AI) that may harness the autonomy and independence that accompany functional limitation or disability, and possibly elevate life expectancy in older adults and people with PD. Methods: ActiveAgeing is a 4-year, multicentre, mixed method, cyclic study that combines digital phenotyping via commercial devices (Empatica E4, Fitbit Sense, and Oura Ring) with traditional evaluation (clinical assessment scales, in-depth interviews, and clinical consultations) and includes four types of participants: (1) people with PD and (2) their informal caregiver; (3) healthy older adults from the Helgetun living environment in Norway, and (4) people on the Helgetun waiting list. For the first study, each group will be represented by N = 15 participants to test the data acquisition and to determine the sample size for the second study. To suggest lifestyle changes, modules for human expert-based advice, machine-generated advice, and self-generated advice from accessible data visualization will be designed. Quantitative analysis of physiological data will rely on digital signal processing (DSP) and AI techniques. The clinical assessment scales are the Unified Parkinson’s Disease Rating Scale (UPDRS), Montreal Cognitive Assessment (MoCA), Geriatric Depression Scale (GDS), Geriatric Anxiety Inventory (GAI), Apathy Evaluation Scale (AES), and the REM Sleep Behaviour Disorder Screening Questionnaire (RBDSQ). A qualitative inquiry will be carried out with individual and focus group interviews and analysed using a hermeneutic approach including narrative and thematic analysis techniques. Discussion: We hypothesise that digital phenotyping is feasible to explore the ageing process from clinical and lifestyle perspectives including older adults and people with PD. Data is used for clinical decision-making by symptom tracking, predicting symptom evolution, and discovering new outcome measures for clinical trials.publishedVersio

Effects of Diversity and Neuropsychological Performance in an NFL Cohort

Objective: The aim of this study was to examine the effect of ethnicity on neuropsychological test performance by comparing scores of white and black former NFL athletes on each subtest of the WMS. Participants and Methods: Data was derived from a de-identified database in South Florida consisting of 63 former NFL white (n=28, 44.4%) and black (n=35, 55.6%) athletes (Mage= 50.38; SD= 11.57). Participants completed the following subtests of the WMS: Logical Memory I and II, Verbal Paired Associates I and II, and Visual Reproduction I and II. Results: A One-Way ANOVA yielded significant effect between ethnicity and performance on several subtests from the WMS-IV. Black athletes had significantly lower scores compared to white athletes on Logical Memory II: F(1,61) = 4.667, p= .035, Verbal Paired Associates I: F(1,61) = 4.536, p = .037, Verbal Paired Associates: II F(1,61) = 4.677, p = .034, and Visual Reproduction I: F(1,61) = 6.562, p = .013. Conclusions: Results suggest significant differences exist between white and black athletes on neuropsychological test performance, necessitating the need for proper normative samples for each ethnic group. It is possible the differences found can be explained by the psychometric properties of the assessment and possibility of a non-representative sample for minorities, or simply individual differences. Previous literature has found white individuals to outperform African-Americans on verbal and non-verbal cognitive tasks after controlling for socioeconomic and other demographic variables (Manly & Jacobs, 2002). This highlights the need for future investigators to identify cultural factors and evaluate how ethnicity specifically plays a role on neuropsychological test performance. Notably, differences between ethnic groups can have significant implications when evaluating a sample of former athletes for cognitive impairment, as these results suggest retired NFL minorities may be more impaired compared to retired NFL white athletes