Personalized Parkinson Project PSP Cohort
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Annual change in digital biomarkers for falls
研究概览
简要总结
There is an urgent need for the development of digital progression biomakers, which are sensitive to detect small, but potentially clinically relevant changes in the disease course. Digital biomarkers are based on (i) continuously collected real-time data, during the patient's day to day activities; and (ii) task-based assessment. In this study the investigators are interested in developing algorithms for the detection of disease progression in PSP patients in key clinical parameters: bradykinesia, gait, rising from a chair and falls, based on (i) sensor data obtained by means of passive monitoring during daily living; and (ii) sensor data collected during the Virtual Motor Exam.
详细描述
Rationale In light of the advent of a wide range of new disease modifying treatments, and acknowledging that existing clinical outcome measures may well be insufficiently sensitive to detecting small but potentially clinically relevant changes in the disease course, there is an urgent need for development of digital progression biomarkers, not only in the field of Parkinson's disease, but also in the field of the various forms of atypical parkinsonism, including Progressive Supranuclear Palsy (PSP).
Study Design Prospective, longitudinal, single-center cohort study.
Study Objectives The primary objective is to develop algorithms for the detection of disease progression in PSP patients in key clinical parameters: bradykinesia, gait, rising from a chair and falls, based on (1) sensor data obtained by means of passive monitoring during daily living; and (2) sensor data collected during the Virtual Motor Exam.
The second objective of this study is to create a longitudinal dataset describing the clinical and functional characteristics of a representative PSP cohort to allow researchers to investigate important unanswered questions in PSP.
Study population 50 patients with possible or probable PSP, according to established international criteria (i.e., MDS-PSP criteria); diagnosis confirmed by consensus review of a videotaped neurological examination by two neurologists with deep expertise in movement disorders. In addition, we will include 50 age and gender matched healthy controls.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Annual change in digital biomarkers for falls
时间窗: From baseline till one year follow-up
Identify (a combined set of) falls-related features extracted from wearable sensor data, that are relevant for patients and that are sensitive to disease progression in PSP patients. Which outcome and which Unit of Measure for falls will be selected cannot be defined on forehand, as this is part of the analytical approach.
Annual change in digital biomarkers for bradykinesia
时间窗: From baseline till one year follow-up
Identify (a combined set of) bradykinesia-related features extracted from wearable sensor data, that are relevant for patients and that are sensitive to disease progression in PSP patients. Which outcome and which Unit of Measure for bradykinesia will be selected cannot be defined on forehand, as this is part of the analytical approach.
Annual change in digital biomarkers for gait
时间窗: From baseline till one year follow-up
Identify (a combined set of) gait-related features extracted from wearable sensor data, that are relevant for patients and that are sensitive to disease progression in PSP patients. Which outcome and which Unit of Measure for gait will be selected cannot be defined on forehand, as this is part of the analytical approach.
Annual change in digital biomarkers for rising from a chair
时间窗: From baseline till one year follow-up
Identify (a combined set of) features related to rising from a chair extracted from wearable sensor data, that are relevant for patients and that are sensitive to disease progression in PSP patients. Which outcome and which Unit of Measure for rising from a chair will be selected cannot be defined on forehand, as this is part of the analytical approach.
次要结局
- Annual change in digital biomarker for motor performance(Baseline till one year follow-up)
- Annual change in cognition(Baseline till one year follow-up)
- Annual change in D-KEFS trail making test(Baseline till one year follow-up)
- Annual change in semantic fluency(Baseline till one year follow-up)
- Annual change in quality of life(Baseline till one year follow-up)
- Annual change in Activities of Daily Living (ADL) performance(Baseline till one year follow-up)