French Validation Study of a New Scale for Neuropsychiatric Fluctuations in Parkinson Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 12
- 主要终点
- validation of FN scale: realiability
研究概览
简要总结
Neuropsychiatric fluctuations (NF) are among the most disabling non motor fluctuations in Parkinson disease (PD). The investigators developed the NF-scale for acute assessment of non-motor neuropsychiatric fluctuations between the off- and on-medication conditions in PD. The main goal of this project is to validate the NF-scale in french language in a multicenter approach.
详细描述
Anxiety, sadness, lack of energy and motivation, fatigue and pain are common during the off-medication condition, whereas euphoria, well-being, impulse control disorders, behavioral addictions, mania, and psychosis might occur during the on-medication condition. Early diagnosis of NpsyF is crucial for their holistic management. Unfortunately, NpsyF are often under-recognized by patients or misdiagnosed by physicians due to the lack of specific assessment tools. The NFS is composed of 20 items among which ten measure the "ON neuropsychological state" and ten, the "OFF neuropsychological state". It provides two sub-scores (one ON and one OFF) with a maximal total score of 30.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic Parkinson's disease
- •presence of motor fluctuations, requiring a levodopa test
- •french native speaker
排除标准
- •Dementia (MoCa < 24)
- •Parkinson syndrome other than idiopathic PD
- •people excluded according to french law (including pregnant women or nursing mothers, ...)
结局指标
主要结局
validation of FN scale: realiability
时间窗: 2 months
EFN score
validation of FN scale: internal consistency
时间窗: 4 hours
EFN score
validation of FN scale: measurement error
时间窗: 2 months
test-retest
validation of FN scale: responsiveness
时间窗: 4 hours
validation of FN scale: structural validity
时间窗: 4 hours
EFN score
validation of FN scale: acceptability
时间窗: 4 hours
EFN score
次要结局
- correlation of EFN scores with socio-clinical characteristics 1(4 hours)
- correlation of EFN scores with socio-clinical characteristics (7)(4 hours)
- correlation of EFN scores with socio-clinical characteristics 3(4 hours)
- correlation of EFN scores with socio-clinical characteristics (5)(4 hours)
- correlation of EFN scores with socio-clinical characteristics (6)(4 hours)
- correlation of EFN scores with socio-clinical characteristics (9)(4 hours)
- correlation of EFN scores with socio-clinical characteristics (4)(4 hours)
- correlation of EFN scores with socio-clinical characteristics 2(4 hours)
- correlation of EFN scores with socio-clinical characteristics (8)(4 hours)