Pain Assessment in Patients With Idiopathic REM Sleep Behaviour Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Comparison of the intensity of chronic pain between patients with iRBD and a control group of patients
研究概览
简要总结
Parkinson's disease (PD) is the second most common neurodegenerative disorder after Alzheimer's disease, with over 12 million patients expected globally by 2040. The disease is currently diagnosed at the appearance of motor symptoms, but by then, over 60% of striatal dopaminergic neurons have already been destroyed. Prodromal symptoms such as idiopathic REM Sleep Behavior Disorder (iRBD), anosmia, mood disorders and constipation appear earlier and are listed as criteria for a prodromal PD diagnosis. Identifying early signs is critical to initiate neuroprotective treatments as early as possible. While pain is prevalent and highly disabling in early PD, no data are currently available on pain perception in iRBD patients, whose condition is of the main risk factor for PD development.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with iRBD confirmed by polysomnography;
- •No clinical diagnosis of Parkinson's disease or other diagnosis of neurodegenerative disease;
- •Ability to understand and complete study procedures and questionnaires;
- •Control group:
- •Diagnosed with narcolepsy type 1;
- •Coexisting REM sleep behavior disorder confirmed by polysomnography;
- •Ability to understand and complete study procedures and questionnaires;
排除标准
- •Diagnosed Parkinson's Disease, dementia with Lewy bodies or multiple system atrophy;
- •Severe depression according to Diagnostic and Statistical Manual of Mental Disorders (DSM V);
- •Inability to complete study procedures or questionnaires.
研究组 & 干预措施
Idiopathic REM Sleep Bhavior Disorder (iRBD) + narcolepsy type 1
patients who have an iRBD and who have type 1 narcolepsy
干预措施: Pain questionnaires (Other)
Idiopathic REM sleep Behavior disorder (iRBD) Group
Patients who have an idiopathic REM sleep Behavior Disorder
干预措施: Thermo test pain (Other)
Idiopathic REM sleep Behavior disorder (iRBD) Group
Patients who have an idiopathic REM sleep Behavior Disorder
干预措施: Pain questionnaires (Other)
Idiopathic REM sleep Behavior disorder (iRBD) Group
Patients who have an idiopathic REM sleep Behavior Disorder
干预措施: No motors symptoms evaluations (Other)
Idiopathic REM Sleep Bhavior Disorder (iRBD) + narcolepsy type 1
patients who have an iRBD and who have type 1 narcolepsy
干预措施: Thermo test pain (Other)
Idiopathic REM Sleep Bhavior Disorder (iRBD) + narcolepsy type 1
patients who have an iRBD and who have type 1 narcolepsy
干预措施: No motors symptoms evaluations (Other)
结局指标
主要结局
Comparison of the intensity of chronic pain between patients with iRBD and a control group of patients
时间窗: 2 hours after the inclusion
Measuring the Visual Analog Scale (VAS) between patients with iRBD without diagnosis of PD and a control group of patients diagnosed with narcolepsy type 1 who present RBD (Rapid eye movement sleep behavior disorder).
次要结局
- Describe semiological characteristics of pain in RBD patients(2 hours after the inclusion)
- Compare the presence of chronic pain(2 hours after the inclusion)
- Assessing Pain Characteristics(2 hours after the inclusion)
- Assessment of thermal pain threshold and tolerance(2 hours after the inclusion)
- Assessment of correlations between the intensity of chronic pain(2 hours after the inclusion)