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.

项目摘要/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，在病理上与阿尔茨海默病有关。在这个项目中， 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 使用可穿戴传感器和数字化测试在FTLD综合征中发挥作用。我们将在以下位置验证此解决方案 60例进行性核上性麻痹(PSP)患者12年间纵向资料的收集 月份。PSP是一种严重且进展迅速的FTLD综合征，缺乏有效的治疗方法，并导致 迅速发病的痴呆症、残疾和死亡。PSP的快速发展将使我们能够验证该解决方案 在这个直接的第二阶段SBIR项目的时间表内，并促进未来对FTLD综合征的研究。 在这个直接二期项目中，我们将从两个领先的CurePSP护理中心招募60名PSP参与者。 这些参与者将接受为期12个月的监测。传感器数据将使用可穿戴设备PAMSys收集 传感器开发的支持下，从美国国立卫生研究院科学技术研究院授予奖。PAMSys获得专利(美国专利编号8,206,325， 9,005,141和9,901,209)，由BioSensics验证和商业化。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记的统一解决方案，目前正在 美国国立卫生研究院资助的几项研究和药物赞助的神经疾病临床试验。BioSensics已经 已经定制了BioDigit Home解决方案来监控PSP的运动、语音和认知功能，并拥有 对7名PSP患者进行了一项初步研究，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名PSP患者的数据，以此为目标开发一套监测运动、言语的算法 和认知功能，从而能够客观评估PSP疾病的严重程度和进展 为PSP打造多模式远程监控解决方案。这些工具将加速临床试验，这些试验 专注于开发治疗紧张症的新疗法(即FTD，PSP CBS)，并可以很容易地 适应许多神经退行性疾病，包括帕金森氏病，多系统萎缩， 肌萎缩侧索硬化症、强直性肌营养不良和中风。 BioSensics是2020年Tibbetts奖获得者，应用了经过验证的快速过渡记录 将政府研究经费转化为真正的商业成果。我们技术的初始市场是 制药临床试验，其中BioSensics是医用级可穿戴传感器和 为多家制药公司提供数字化临床试验技术。当前的项目将显著地 扩大BioSensics向制药公司提供的产品范围，特别是通过提供数字解决方案 对语言、运动和认知功能的评估，这与许多疾病有关。这则广告 潜力与FDA、NSF和NIH关于临床试验数字化的最新建议完全一致。