A Multi-Modal Remote Monitoring Platform for Frontotemporal Lobar Degeneration Syndromes

额颞叶变性综合征的多模式远程监测平台

• 批准号: 10707379
• 负责人: Alexander Y. Pantelyat
• 金额: $ 124.64万
• 依托单位: BIOSENSICS, LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-30 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10707379
• 关键词: Acceleration; Activities of Daily Living; Affect; Algorithms; Alzheimer' s Disease; Alzheimer' s disease related dementia; Amyotrophic Lateral Sclerosis; Anxiety; Architecture; Attitude; Award; Basal Ganglia; Biological Markers; Caring; Cessation of life; Clinic; Clinical Research; Clinical Trials; Cognition; Cognitive; Collaborations; Collection; Data; Data Collection; Data Security; Dementia; Dementia with Lewy Bodies; Deposition; Development; Digital biomarker; Disease; Disease Outcome; Disease Progression; Dysarthria; FDA approved; Feedback; Frontotemporal Dementia; Frontotemporal Lobar Degenerations; Funding; Future; Gait; General Hospitals; Grant; Health Technology; Home; Individual; Interview; Legal patent; Marketing; Massachusetts; Measurement; Measures; Medical Records; Modeling; Monitor; Motor; Movement; Multicenter Studies; Multiple System Atrophy; Myotonic Dystrophy; Neck; Neurodegenerative Disorders; Outcome; Outcome Measure; Parkinson Disease; Participant; Pathologic; Patient Outcomes Assessments; Patients; Perception; Persons; Pharmacologic Substance; Phase; Physical activity; Physical assessment; Pilot Projects; Posture; Progressive Supranuclear Palsy; Protocols documentation; Psychomotor Performance; Quality of life; Recommendation; Research; Research Design; Risk; Severity of illness; Small Business Innovation Research Grant; Small Business Technology Transfer Research; Speech; Stroke; Symptoms; Syndrome; System; Systems Development; Tablets; Tauopathies; Technology; Testing; Therapeutic Effect; Therapeutic Intervention; Trust; United States National Institutes of Health; Universities; Vendor; cognitive function; cognitive testing; commercialization; computerized; corticobasal syndrome; data access; digital; digital assessment; disability; effective therapy; equilibration disorder; fall risk; falls; improved; instrument; mHealth; machine learning algorithm; motor symptom; multimodality; nervous system disorder; novel therapeutics; primary outcome; recruit; remote monitoring; sensor; tau Proteins; tau mutation; timeline; tool; virtual visit; wearable sensor technology; web app

Project Summary/Abstract Frontotemporal lobar degeneration (FTLD) syndromes span the spectrum of neurodegenerative disorders affecting movement and cognitive function and are pathologically related to Alzheimer's disease. In this project, we will develop a robust multi-modal platform for remote monitoring of motor symptoms, speech and cognitive function in FTLD syndromes using wearable sensors and digitized tests. We will validate this solution in Progressive Supranuclear Palsy (PSP) by collecting longitudinal data from 60 PSP patients over a period of 12 months. PSP is a severe and rapidly progressive FTLD syndrome that lacks effective treatment and leads to rapid onset of dementia, disability and death. The rapid progression of PSP will allow us to validate the solution within the timeline of this Direct Phase II SBIR project and facilitate future studies in FTLD syndromes. In this Direct Phase II project, we will recruit 60 participants with PSP from 2 leading CurePSP Centers of Care. These participants will be monitored for 12 months. The sensor data will be collected using PAMSys, a wearable sensor developed by the support from a NIH STTR grant award. PAMSys is patented (U.S. Patents # 8,206,325, 9,005,141, and 9,901,209), validated and commercialized by BioSensics. The digitized tests will be collected using BioDigit Home, a unified solution for the collection of digital biomarkers that is currently being used in several NIH-funded studies and pharma-sponsored clinical trials in neurological disorders. BioSensics has already customized its BioDigit Home solution to monitor motor, speech and cognitive functions in PSP, and has carried out a pilot study with 7 PSP patients, who were monitored for up to 3 months using the developed system. We will collect data from 60 PSP patients in this aim to develop a set of algorithms for monitoring motor, speech and cognitive function that will enable objective assessment of PSP disease severity and progression, thereby creating a multi-modal remote monitoring solution for PSP. These tools will accelerate clinical trials that are focused on the development of novel therapeutics for tauopathies (i.e., FTD, PSP CBS) and can be readily adapted to many neurodegenerative diseases, including Parkinson's disease, multiple system atrophy, amyotrophic lateral sclerosis, myotonic dystrophy and stroke. BioSensics is a 2020 Tibbetts Award winner with a proven track record of rapidly transitioning applied governmental research funding into real commercial results. The initial market for our technology is pharmaceutical clinical trials, where BioSensics is a vendor of record of medical-grade wearable sensors and digital clinical trial technologies for multiple pharmaceutical companies. The current project will significantly broaden BioSensics' offerings to pharmaceutical companies, specifically by providing a solution for digital assessments of speech, motor and cognition function, which are relevant to many diseases. This commercial potential is fully aligned with the latest recommendations from the FDA, NSF and NIH to digitize clinical trials.

项目总结/摘要 额颞叶变性（FTLD）综合征跨越神经退行性疾病的范围 影响运动和认知功能，并且在病理上与阿尔茨海默病相关。在本项目中， 我们将开发一个强大的多模式平台，用于远程监测运动症状、言语和认知 功能FTLD综合征使用可穿戴传感器和数字化测试。我们将在 通过收集60例进行性核上性麻痹（PSP）患者12年的纵向数据， 个月PSP是一种严重且快速进展的FTLD综合征，缺乏有效的治疗， 痴呆、残疾和死亡的快速发作。PSP的快速发展将使我们能够验证解决方案 在该直接II期SBIR项目的时间轴内，并促进FTLD综合征的未来研究。 在这个直接的第二阶段项目中，我们将从2个领先的CurePSP护理中心招募60名PSP参与者。 这些参与者将被监测12个月。传感器数据将使用PAMSys收集，PAMSys是一种可穿戴设备， 传感器开发的支持下，从美国国立卫生研究院STTR赠款奖。PAMSys已获得专利（美国专利号8，206，325， 9，005，141和9，901，209），由BioSensics验证并商业化。数字化测试将被收集 使用BioDigit Home，这是一种用于收集数字生物标志物的统一解决方案，目前正用于 几项NIH资助的研究和制药公司赞助的神经系统疾病临床试验。BioSensics拥有 已经定制了其BioDigit Home解决方案，以监测PSP的运动，语言和认知功能，并已 对7名PSP患者进行了初步研究，使用开发的系统对他们进行了长达3个月的监测。 我们将收集60例PSP患者的数据，旨在开发一套用于监测运动，语言， 和认知功能，这将使客观评估PSP疾病的严重程度和进展， 为PSP创建多模式远程监控解决方案。这些工具将加速临床试验， 专注于开发用于Tau蛋白病的新疗法（即，FTD、PSP CBS），并可随时 适用于许多神经退行性疾病，包括帕金森病，多系统萎缩， 肌萎缩侧索硬化症、强直性肌营养不良症和中风。 BioSensics是2020年Tibbetts奖赢家，在快速过渡应用方面有着良好的记录 把政府的研究资金转化为真实的商业成果。我们的技术最初的市场是 制药临床试验，其中BioSensics是医疗级可穿戴传感器的记录供应商， 为多家制药公司提供数字化临床试验技术。目前的项目将大大 扩大BioSensics为制药公司提供的产品，特别是通过提供数字化解决方案， 评估言语、运动和认知功能，这与许多疾病有关。这个商业 潜力完全符合FDA，NSF和NIH的最新建议，以支持临床试验。