NCT04212637Unknown不适用
Study of Eye Movements (EYE) as Early Markers of Brain Dysfunction (BRAIN) in Parkinson's Disease (PARK)
University Hospital, Grenoble2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- MRI images
研究概览
简要总结
Identify the neural bases of eye movements during visual tasks and their dysfunction at early stages of Parkinson disease (de novo).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Visual acuity normal or corrected to normal
- •Affiliation to a social security scheme (copy of the vital card in support)
- •Signed informed consent
- •Medical examination according to the participation in the MRI examination
- •MMSE score> 23/30
- •For Parkinson patient:
- •Diagnosis of Parkinson's disease
- •Presence of asymmetric bradykinesia and rest tremor and / or stiffness
- •Hoehn & Yahr Stadium I-II / V
排除标准
- •Unprotected Majors unable to express their consent
- •Protected Major (Persons mentioned in Articles L1121-5,6 and 8 of the public health code)
- •Significant hearing or motor impairment
- •Past or present neuropsychiatric pathology (except benign epilepsy)
- •Taking narcotics and / or drugs for neurocognitive purposes
- •Existence of a severe condition in general (cardiac, respiratory, hematological, renal, hepatic, cancerous)
- •Any other neurodegenerative pathology or treatment that may affect the oculomotor control
- •For Parkinson patient:
- •Treatment for Parkinson's disease (except the inhibitors of monoaminoxidase B or MAO-B, such as selegiline and rasagiline).
结局指标
主要结局
MRI images
时间窗: 1 hour
Functional and anatomical brain volumes
次要结局
- Eye latency(1 hour)
- eye amplitude(1 hour)
研究者
研究点 (2)
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