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.
Neurol Sci. 2024 Jul;45(7):3125-3135. doi: 10.1007/s10072-024-07403-0. Epub 2024 Feb 21.
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.
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.
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.
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.
创新的数字解决方案正在塑造新的痴呆症护理概念，为预防、诊断、监测和治疗开辟了新的途径。为此，我们报告了一种基于平板电脑的远程神经心理学平台（Tenèpsia®）的开发，该平台从概念到按照新的医疗器械法规 745/2017 认证为 IIA 类医疗器械。
该平台专为远程认知评估而设计，是由一个包括来自三个意大利科学协会的专家和 Biogen Italia S.r.l.（简称“Biogen”）以及 Xenia Reply 和 Inside AI 的开发人员在内的合作工作组共同努力的结果。开发策略是通过将传统的纸笔测试转化为数字版本来指导的，同时保持神经心理学特征的可比性，并优化患者的可及性和用户体验。专家们专注于选择和改编传统的神经心理学测试，以进行 45 分钟的远程神经心理学评估。
开发人员分别为专业人员（神经心理学家）和非专业人员（患者和护理人员）创建了网络和移动界面。实现了语音、绘图和输入信息的记录。即时仪表盘提供了患者状况的快速概述。进行了模拟活动以获得欧洲范围内有效的医疗器械认证。
神经心理学服务将受益于在诊所中实施具有适当科学和技术标准的协调数字工具。使用数字认知测试来诊断轻度认知障碍预计将通过简化、数字化的客观数据收集来改善患者和临床医生的结果，节省时间和资源，从而对医疗保健成本和治疗机会产生积极影响，减少诊断和治疗方面的不平等和延迟。
