Microstructural Brain MRI Biomarkers in Patients With Idiopathic REM Sleep Behaviour Disorder at 7 Tesla
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- 3D cartography difference of Fractional anisotropy between the iRBD and control subjects
研究概览
简要总结
By 2030 the number of patients with Parkinson's Disease (PD) would increase by 56% affecting 1 out of 120 people older than 45 years-old. It is known that 10-15 years before the onset motor symptoms such as tremor, rigidity and akinesia, patients often experience a specific sleep trouble called REM sleep behaviour disorder (RBD). Follow-up of those subjects showed there was a conversion rate to PD and related disorders (called synucleinopathies) over 80%.
The pathophysiology of RBD is poorly understood. The development of cutting-edge technologies such as 7 Tesla MRI and the optimisation of image processing methods made it possible to non-invasively explore in vivo small brain structures involved in sleep and movement disorders.
The investigators hypothesize that brain and brainstem microstructure, composition, sodium homeostasis and connectivity may change in 15 isolated RBD (iRBD) subjects compared with 15 healthy controls and that these changes may be correlated with clinical scores.
This study would help fill the gap in early diagnosis of synucleinopathies, by contributing to better targeting patients who could be included in therapeutic trials with a neuroprotective effect. Besides, the exploration of original pathophysiological pathways such as sodium homeostatis could provide the necessary arguments for the development of new target therapeutics.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for patients with REM Sleep Behaviour Disorder :
- •Patient aged between 40 and 80 years old
- •Patient fulfilling the diagnostic criteria for RBD (International Classification of Sleep Disorders version 3, American Academy of Sleep Medicine, 2014) with polysomnographic confirmation (which will be carried out as part of the routine work-up);
- •UPDRS Part III score under or equal to 5
- •The patient is enrolled in the French social security system
- •The patient understood and signed the consent to participate in the study.
- •Inclusion Criteria for control group :
- •Patient aged between 40 and 80 years old
- •Score under or equal 4 for the RBD screening questionnaire
- •UPDRS Part III score under or equal 5
- •The patient is enrolled in the French social security system
- •The patient understood and signed the consent to participate in the study.
排除标准
- •Patient / Subject with a history of central nervous system disease (e.g. PD, Alzheimer's disease, stroke, brain tumour, multiple sclerosis, amyotrophic lateral sclerosis, etc.). If a doubt exist, this criterion will be left to the judgement of the principal investigator, who is a neurologist.
- •Contraindications to 7T MRI: presence of a metal in the body or in the eye, patient with a pacemaker or neurostimulator, cochlear implants or any implanted electronic medical equipment in general, metallic heart valve, aneurysm clips.
- •Claustrophobia.
- •Montreal Cognitive Assessment Test (MOCA) < 25/30
- •Pregnant or breast-feeding woman or protected person (under guardianship, curatorship, deprived of liberty).
结局指标
主要结局
3D cartography difference of Fractional anisotropy between the iRBD and control subjects
时间窗: Time of the Inclusion
Fractional anisotropy between 0 and 1
3D cartography difference of Mean diffusivity between the iRBD and control subjects
时间窗: Time of the Inclusion
Mean diffusivity in mm2/s
3D cartography the rate of difference of atrophy between the idiopathic REM Sleep Behaviour Disorder (iRBD) and control subjects
时间窗: Time of the Inclusion
Voxel based morphometry evaluated with Matlab and SnPM
3D cartography difference of neuromelanin between the iRBD and control subjects with T1 sequence
时间窗: Time of the Inclusion
Neuromelanin contrast ratio
3D cartography difference of neuromelanin between the iRBD and control subjects with Magnetization transfert sequence
时间窗: Time of the Inclusion
Magnetization transfert contrast ratio
3D cartography the rate of difference of Quantitative Susceptibility Mapping between the iRBD and control subjects
时间窗: Time of the Inclusion
Iron load evaluation in ppb
次要结局
- 3D cartography difference of total sodium concentration between the iRBD and control subjects(Time of the Inclusion)
- 3D cartography difference of structural brain connectivity between the iRBD and control subjects(Time of the Inclusion)
- Rate of Dependency between MRI parameters and demographic data(Time of the Inclusion)
- Rate of Dependency between MRI parameters and demographic data, clinical scores/questionnaires(Time of the Inclusion)
- Rate of Dependency between MRI parameters and clinical scores/questionnaires(Time of the Inclusion)