A Multi-Modal Remote Monitoring Platform for Frontotemporal Lobar Degeneration (FTLD) Syndromes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Feasibility
研究概览
简要总结
The primary objective of this study is to enroll an observational cohort of approximately 60 patients with PSP over the course of 24 months using a multicenter study design and to follow each of them for 12 months.
The secondary objective of this study is to develop a robust solution for multi-modal remote monitoring of motor symptoms and function in PSP that can be applied to other Frontotemporal lobar degeneration (FTLD) syndromes.
详细描述
The goal of this project is to develop a robust multi-modal platform for remote monitoring of motor symptoms and cognitive function in FTLD syndromes using wearable sensors and mobile health technology to assess speech, motor, and cognitive functions. The solution will be validated in Progressive Supranuclear Palsy (PSP) by collecting longitudinal data from 60 PSP individuals with PSP. Enrollment will take place over a period of 24 months, though each participant will only be followed for 12 months for data collection. The participants will consist of adult volunteers from two leading CurePSP Centers of Care located at the Atypical Parkinsonism Center at Johns Hopkins Hospital in Baltimore, MD and Massachusetts General Hospital (MGH) in Boston, MA.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of possible or probable PSP as defined by the 2017 MDS criteria
- •Fluent in reading and speaking English and capable of providing informed consent based on the principal investigator's judgement
- •Able to walk 10 feet unassisted at the time of initial enrollment
- •Must have a caregiver or study partner who is willing and able to assist with all study-related procedures
排除标准
- •Any neurological, medical, or psychiatric condition that would preclude participation in study activities based on the investigator's judgment.
- •A history of frequent falls defined as more than 5 falls per month, or who require a walker to ambulate safely at baseline will not be eligible to participate in the study.
结局指标
主要结局
Feasibility
时间窗: 12 months
Feasibility will be defined by the number of participants who complete the 12 month study and who wear their PAMSys pendant sensors at least 16 hours/day for at least 75% of the designated sensor days (7 days per month).
次要结局
- PSPRS(12 months)
- Cortical Basal ganglia Functional Scale (CBFS)(12 months)
- PSP Quality of Life scale (PSP QoL)(12 months)
研究者
Anne-Marie Alexandra Wills, MD
Assistant Professor of Neurology
Massachusetts General Hospital