TwinBrain Parkinson's Disease Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- dual-task costs while standing
研究概览
简要总结
Neuromuscular dysfunction is common in older adults and even more pronounced in neurodegenerative diseases. In Parkinson's disease (PD), a complex set of factors often prevents effective performance of activities of daily living that require intact and simultaneous performance of motor and cognitive tasks. In the current study we aim at employing the Mobile Brain/Body Imaging approach (MoBI) to gain further insides of neuromuscular biomarkers revealing the decrements of older adults with an early PD. The cross-sectional study will be evaluated through the multifactorial mixed-measure design.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for the healthy older participants will be:
- •no diagnosis of cognitive or movement disorder,
- •score > 7 for the Short Physical Performance Battery (SPPB),
- •living independently in the community,
- •age range between 55 and 70 years,
- •no color blindness.
- •Inclusion criteria for the early-stage PD patients:
- •diagnosed according to the last MDS criteria (2015),
- •duration of the disease less than 5 years,
- •positive DATSCAN,
- •diagnosed akinetic-rigid or mixed phenotype,
- •score of 1 or maximally 2 on the Hoehn and Yahr scale (Hoehn & Yahr, 1967),
- •MoCA score ≥ 24 points,
- •score > 7 for the SPPB,
- •age range between 50 and 75 years,
- •no color blindness
- •living independently in the community.
排除标准
- •advanced stages of PD (Hoehn and Yahr score > 2)
- •any acute or chronic diseases, especially of the peripheral and central nervous system, heart failure, respiratory failure, severe osteoarthritis, and major psychiatric illness such as depression
- •MoCA score < 24 points,
- •severe disabling tremor,
- •recurrent falls,
- •impaired vision that is not corrected with e.g., glasses,
- •low SPPB score
结局指标
主要结局
dual-task costs while standing
时间窗: Day 1
Test for dual-task costs associated with the concurrent execution of semi-tandem stance and a secondary cognitive task
dual-task costs while execution of isometric task
时间窗: Day 1
Test for dual-task costs associated with the concurrent execution of isometric contraction and a secondary cognitive task
dual-task costs while walking
时间窗: Day 1
Test for dual-task costs associated with the concurrent execution of overground walking and a secondary cognitive task
次要结局
- The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)(Day 1)
研究者
Marusic
Associate professor
Science and Research Centre Koper