Exploration of the Mechanism of Movement Improvement During Rapid Eye Movement (REM) Sleep Behaviour Disorder (RBD) in Parkinson's Disease Using Near-infrared Spectroscopy (NIRS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Difference of signal NIRS on the supplementary motor area (SMA) during the movement realized during the REM sleep behaviour disorder (RBD) and reproduced in standby in the patient parkinsonian in "on".
研究概览
简要总结
The purpose of this study is to confirm the improvement of movement during RBD in Parkinson's disease and to explore the neuronal network involved in this improvement using NIRS.
详细描述
The aim of this study is to compare the quality of movement during REM sleep during RBD episodes and movement awake without and with dopaminergic treatment while measuring cortical activity using NIRS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic Parkinson's Disease (Hughes AJ et al., 2001)
- •Patients with REM sleep behaviour sleep disorder according to the ICSD2 (International Classification of Sleep Disorders 2) criteria and frequent reported several times per week by the spouse
- •Informed written consent signed
- •Patient aged 40 to 90 years
- •Affiliate or benefiting from a social security scheme.
排除标准
- •Atypical Parkinson's Syndromes
- •Patient not accepting polysomnography
- •Contraindications to cerebral Magnetic Resonnance Imaging (MRI): pacemaker, cochlear implants, certain heart valves, claustrophobia, pregnancy.
- •Limit of validity of the MRI: if the patient presents dyskinesias preventing immobile maintenance of a few minutes in the MRI for the acquisition of images
结局指标
主要结局
Difference of signal NIRS on the supplementary motor area (SMA) during the movement realized during the REM sleep behaviour disorder (RBD) and reproduced in standby in the patient parkinsonian in "on".
时间窗: 24 hours
Difference of signal NIRS on the supplementary motor area (SMA) during the movement realized during the REM sleep behaviour disorder (RBD) and reproduced in standby in the patient parkinsonian in "on" (means that the patient is under effective dopaminergic treatment). The NIRS signal corresponds to the area under curve (AUC) of the oxyhemoglobin (O2Hb) and desoxyhemoglobin concentration's variation during duration of the movement.
次要结局
- Difference of NIRS signal in different cortical regions and in different conditions: rest, movement "on" and "off", RBD, and in standby.(24 hours)
- Difference of movement speed measured by accelerometers under different conditions.(24 hours)