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| ID | Type | Description | Link |
|---|---|---|---|
| ID-RCB | Other Identifier | 2023-A00457-38 |
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| Name | Class |
|---|---|
| Aix Marseille Université | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with REM Sleep Behaviour Disorder | Other |
| |
| Healthy volunteers | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 7T MRI | Other | Subjects will have a 7T MRI and questionnaires on the only day of clinical study. |
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| Measure | Description | Time Frame |
|---|---|---|
| 3D cartography the rate of difference of atrophy between the idiopathic REM Sleep Behaviour Disorder (iRBD) and control subjects | Voxel based morphometry evaluated with Matlab and SnPM | Time of the Inclusion |
| 3D cartography difference of neuromelanin between the iRBD and control subjects with T1 sequence | Neuromelanin contrast ratio | Time of the Inclusion |
| 3D cartography difference of neuromelanin between the iRBD and control subjects with Magnetization transfert sequence | Magnetization transfert contrast ratio | Time of the Inclusion |
| 3D cartography the rate of difference of Quantitative Susceptibility Mapping between the iRBD and control subjects | Iron load evaluation in ppb | Time of the Inclusion |
| 3D cartography difference of Mean diffusivity between the iRBD and control subjects | Mean diffusivity in mm2/s | Time of the Inclusion |
| 3D cartography difference of Fractional anisotropy between the iRBD and control subjects | Fractional anisotropy between 0 and 1 | Time of the Inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| 3D cartography difference of total sodium concentration between the iRBD and control subjects | total sodium concentration in mmol/L acquired with a specificic MRI coil | Time of the Inclusion |
| 3D cartography difference of structural brain connectivity between the iRBD and control subjects |
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Inclusion Criteria for patients with REM Sleep Behaviour Disorder :
Inclusion Criteria for control group :
Exclusion Criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Francois Cremieux | Assistance Publique - Hôpitaux de Marseille | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance - Publique Hôpitaux de Marseille | Marseille | 13005 | France |
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| ID | Term |
|---|---|
| D020187 | REM Sleep Behavior Disorder |
| D010300 | Parkinson Disease |
| D000080874 | Synucleinopathies |
| ID | Term |
|---|---|
| D020923 | REM Sleep Parasomnias |
| D020447 | Parasomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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A network-based statistics analysis will be performed: from Diffusion tensor imaging, a connectivity matrix will be populated for each subject. A t-test contrasting the two groups (iRBD and control subjects) will then be computed for each pairwise association. Finally, permutation testing will be used to ascribe a p-value controlled for the family-wise error rate to each connected component based on its size. |
| Time of the Inclusion |
| Rate of Dependency between MRI parameters and demographic data | Pearson, Spearman or logistic regression, depending on the age and MRI parameters | Time of the Inclusion |
| Rate of Dependency between MRI parameters and demographic data | Pearson, Spearman or logistic regression, depending on the sex and MRI parameters | Time of the Inclusion |
| Rate of Dependency between MRI parameters and demographic data | Pearson, Spearman or logistic regression, depending on the laterality and MRI parameters | Time of the Inclusion |
| Rate of Dependency between MRI parameters and demographic data, clinical scores/questionnaires | Pearson, Spearman or logistic regression, depending on the MDS-UPDRS I (Movement disorders society - Unified Parkinson's Disease Rating Scale) scale and MRI parameters | Time of the Inclusion |
| Rate of Dependency between MRI parameters and clinical scores/questionnaires | Pearson, Spearman or logistic regression, depending on the MDS-UPDRS II scale and MRI parameters | Time of the Inclusion |
| Rate of Dependency between MRI parameters and clinical scores/questionnaires | Pearson, Spearman or logistic regression, depending on the MDS-UPDRS III scale and MRI parameters | Time of the Inclusion |
| Rate of Dependency between MRI parameters and clinical scores/questionnaires | Pearson, Spearman or logistic regression, depending on the SCOPA-AUT scale and MRI parameters | Time of the Inclusion |
| Rate of Dependency between MRI parameters and clinical scores/questionnaires | Pearson, Spearman or logistic regression, depending on the HAD scale (Hospital Anxiety and Depression scale) and MRI parameters | Time of the Inclusion |
| Rate of Dependency between MRI parameters and clinical scores/questionnaires | Pearson, Spearman or logistic regression, depending on the RBD (Rem sleep behaviour disorder) and MRI parameters | Time of the Inclusion |
| Rate of Dependency between MRI parameters and demographic data, clinical scores/questionnaires | Pearson, Spearman or logistic regression, depending on the Pittsburgh sleep quality index and MRI parameters | Time of the Inclusion |
| Rate of Dependency between MRI parameters and clinical scores/questionnaires | Pearson, Spearman or logistic regression, depending on the Starkstein motivation scale and MRI parameters | Time of the Inclusion |
| Rate of Dependency between MRI parameters and clinical scores/questionnaires | Pearson, Spearman or logistic regression, depending on the non motor fluctuation scale and MRI parameters | Time of the Inclusion |
| Rate of Dependency between MRI parameters and clinical scores/questionnaires | Pearson, Spearman or logistic regression, depending on the MoCA scale and MRI parameters | Time of the Inclusion |
| Rate of Dependency between MRI parameters and clinical scores/questionnaires | Pearson, Spearman or logistic regression, depending on the phonemic and category fluencies and MRI parameters | Time of the Inclusion |
| Rate of Dependency between MRI parameters and clinical scores/questionnaires | Pearson, Spearman or logistic regression, depending on the Benton judgement of lines and MRI parameters | Time of the Inclusion |
| Rate of Dependency between MRI parameters and clinical scores/questionnaires | Pearson, Spearman or logistic regression, depending on the quality of life SF-36 and MRI parameters | Time of the Inclusion |
| Rate of Dependency between MRI parameters and clinical scores/questionnaires | Pearson, Spearman or logistic regression, depending on the Miami Hallucinations questionnaire and MRI parameters | Time of the Inclusion |
| Rate of Dependency between MRI parameters and clinical scores/questionnaires | Pearson, Spearman or logistic regression, depending on the treatement intake and MRI parameters | Time of the Inclusion |
| Rate of Dependency between MRI parameters and clinical scores/questionnaires | Pearson, Spearman or logistic regression, depending on the blood pressure test and MRI parameters | Time of the Inclusion |
| D001523 |
| Mental Disorders |
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009069 | Movement Disorders |
| D019636 | Neurodegenerative Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |