Progression of Striatal and Extrastriatal Degeneration in PD and PSP Patients: a Longitudinal Prospective Study for Correlation Between Clinical Manifestations, Gait Analysis and Functional/Diffusion MRI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- Gait profile Score (GPS) in PD and PSP patients
研究概览
简要总结
This longitudinal study aims to research cognitive and gait phenotypes of Parkinson's disease and Supranuclear Palsy as well as to provide markers to track diseases progression using a multi-modality approach based on 3D-gait analysis and MR Imaging.
Specifically, this study want to identify cognitive pattern and gait-related cerebral diffusion/functional connectivity in PD and PSP patients and to verify their progression over a period of 18 months.
In summary, the current protocol proposed to investigate the following issues:
- to perform a multifactorial quantitative analysis of outcomes for PD and PSP compared to a control group in order to categorize cognitive and gait pattern in the group of patients and verify if the gait can be useful as discriminator for diagnosis.
- to analyze whether diffusion and resting-state functional connectivity indices are correlated with clinical disease severity scores and motor scores and how they change over time (18 months later).
详细描述
Gait disorder is one of the key features of Parkinson's disease (PD), often leading to loss of mobility and severe disability. Yet in the early stages of disease, examination of gait may lead to inconclusive results for differential diagnosis between PD and other parkinsonism because slow and small stepped walking is often unspecific and can be related to age, depressive mood, or to a presence of neurodegenerative atypical parkinsonism (AP) such as Progressive Supranuclear Palsy (PSP).
At the same time, emerging evidence indicates that early disturbances in cognitive processes such as attention, executive function, and working memory are associated with slower gait and gait instability during single and dual-task testing.
It is therefore crucial to carefully investigate the multiple cognitive domains in order to identify possible mild cognitive deficits in PD and PSP patients and to correlate them with gait disorders.
The use of quantitative movement analysis with 3D-gait analysis allow an objective multifactorial evaluation of the functional limitation related to PD and PSP patients and can be used to analyze the gait in pathologies characterized by gait impairment compared to healthy control (HC).
This longitudinal clinical study aims to analyze cognitive profiles and gait pattern (with 3D-gait analysis) and their progression (18 months later) in a PD- and a PSP-group, respect to HC group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of idiopathic PD by United Kingdom (UK) Brain Bank criteria and PSP according to NINDS-SPSP criteria, without other significant neurological or orthopedic problems;
- •ages of 20-80;
- •able to walk 25 feet unassisted and without any assistive device
排除标准
- •History of epileptic seizures, head injury, other neurological disorders.
- •Cardiac pacemaker implantation
结局指标
主要结局
Gait profile Score (GPS) in PD and PSP patients
时间窗: 18 months
GPS quantifies the gait pattern deviation of the patient respect to normality range
次要结局
未报告次要终点