A digital teleneuropsychology platform for the diagnosis of mild cognitive impairment: from concept to certification as a medical device.

Autor: Panzavolta A; IUSS Cognitive Neuroscience (ICoN) Center, Scuola Universitaria Di Studi Superiori IUSS, Piazza Della Vittoria 15, 27100, Pavia, Italy., Cerami C; IUSS Cognitive Neuroscience (ICoN) Center, Scuola Universitaria Di Studi Superiori IUSS, Piazza Della Vittoria 15, 27100, Pavia, Italy. chiara.cerami@iusspavia.it.; Dementia Research Center, Mondino Foundation IRCCS, Pavia, Italy. chiara.cerami@iusspavia.it., Caffarra P; Membro esperto Tavolo permanente sulle demenze del Ministero della Salute, Rome, Italy., De Vita D; Department of Psychology, University of Campania 'Luigi Vanvitelli', Caserta, Italy., Dodich A; Center for Mind/Brain Sciences (CIMeC), University of Trento, Rovereto, Italy., Fonti C; IRCCS, Istituto Delle Scienze Neurologiche di Bologna, Bologna, Italy., L'Abbate F; Neurology Unit, Fondazione Policlinico Universitario 'A. Gemelli' IRCCS, Rome, Italy., Laganà V; Associazione Per La Ricerca Neurogenetica Odv, Lamezia Terme, Italy., Lavorgna L; Clinica Neurologica I, Azienda Ospedaliera Universitaria, University of Campania 'Luigi Vanvitelli', Naples, Italy., Marra C; Neurology Unit, Fondazione Policlinico Universitario 'A. Gemelli' IRCCS, Rome, Italy.; Università Cattolica del Sacro Cuore, Rome, Italy., Papagno C; Center for Mind/Brain Sciences (CIMeC), University of Trento, Rovereto, Italy., Pellegrini FF; Geriatric Clinic Unit, Medical Geriatric Rehabilitative Department, University Hospital of Parma, Parma, Italy., Stracciari A; Membro esperto Tavolo permanente sulle demenze del Ministero della Salute, Rome, Italy., Trojano L; Department of Psychology, University of Campania 'Luigi Vanvitelli', Caserta, Italy., Iaquinta T; Xenia Reply, Milan, Italy., Ravizza A; InsideAI, Bologna, Italy., Sternini F; InsideAI, Bologna, Italy.; PolitoBIOMed Lab, Politecnico Di Torino, Turin, Italy., Pandolfi R; Biogen Italia, Milan, Italy., Sanzone S; Biogen Italia, Milan, Italy., Calore M; Biogen Italia, Milan, Italy., Cappa SF; IUSS Cognitive Neuroscience (ICoN) Center, Scuola Universitaria Di Studi Superiori IUSS, Piazza Della Vittoria 15, 27100, Pavia, Italy.; Dementia Research Center, Mondino Foundation IRCCS, Pavia, Italy.
Jazyk: angličtina
Zdroj: Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology [Neurol Sci] 2024 Jul; Vol. 45 (7), pp. 3125-3135. Date of Electronic Publication: 2024 Feb 21.
DOI: 10.1007/s10072-024-07403-0
Abstrakt: Background: Innovative digital solutions are shaping a new concept of dementia care, opening additional venues for prevention, diagnosis, monitoring and treatment. Hereby, we report the development of a tablet-based teleneuropsychology platform (Tenèpsia®), from concept to certification as Medical Device (MD) Class IIA, as per new MD regulation 745/2017.
Methods: The platform was designed for the remote cognitive evaluation and created thanks to the effort of a collaborative working group including experts from three Italian scientific societies and Biogen Italia S.r.l. (hereafter "Biogen"), and developers from Xenia Reply and Inside AI. The development strategy was guided by converting traditional paper-and-pencil tests into digital versions while maintaining comparable neuropsychological features and optimizing patient accessibility and user experience. The experts focused on the choice and adaptation of traditional neuropsychology measures for a 45-min teleneuropsychology assessment.
Results: The developers created a web and a mobile interface, respectively, for the professional (neuropsychologist) and non-professional (patient and caregiver) use. Recording of voice, drawing and typing information was enabled. Instant dashboards provide a quick overview of the patient's condition. Simulation activities were performed to obtain MD certification, valid across Europe.
Conclusion: Neuropsychology services will benefit from the implementation in clinics of harmonized digital tools with adequate scientific and technological standards. The use of digital cognitive testing for the diagnosis of mild cognitive impairment is expected to enhance patient and clinician outcomes through simplified, digital objective data collection, sparing of time and resources, with a positive impact on healthcare costs and access to treatments, reducing inequalities and delays in diagnosis and cure.
(© 2024. Fondazione Società Italiana di Neurologia.)
Databáze: MEDLINE
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