REM Sleep Behaviour Disorder
Conditions
Keywords
7T MRI, Parkinson's disease, synucleinopathies
Brief summary
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.
Interventions
OTHER7T MRI
Subjects will have a 7T MRI and questionnaires on the only day of clinical study.
Sponsors
Assistance Publique Hopitaux De Marseille
Aix Marseille Université
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Exclusion criteria
: * 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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3D cartography the rate of difference of atrophy between the idiopathic REM Sleep Behaviour Disorder (iRBD) and control subjects | 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 | Time of the Inclusion | Neuromelanin contrast ratio |
| 3D cartography difference of neuromelanin between the iRBD and control subjects with Magnetization transfert sequence | Time of the Inclusion | Magnetization transfert contrast ratio |
| 3D cartography the rate of difference of Quantitative Susceptibility Mapping between the iRBD and control subjects | Time of the Inclusion | Iron load evaluation in ppb |
| 3D cartography difference of Mean diffusivity between the iRBD and control subjects | Time of the Inclusion | Mean diffusivity in mm2/s |
| 3D cartography difference of Fractional anisotropy between the iRBD and control subjects | Time of the Inclusion | Fractional anisotropy between 0 and 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3D cartography difference of total sodium concentration between the iRBD and control subjects | Time of the Inclusion | total sodium concentration in mmol/L acquired with a specificic MRI coil |
| 3D cartography difference of structural brain connectivity between the iRBD and control subjects | Time of the Inclusion | 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. |
| Rate of Dependency between MRI parameters and demographic data | Time of the Inclusion | Pearson, Spearman or logistic regression, depending on the age and MRI parameters |
| Rate of Dependency between MRI parameters and demographic data, clinical scores/questionnaires | Time of the Inclusion | Pearson, Spearman or logistic regression, depending on the MDS-UPDRS I (Movement disorders society - Unified Parkinson's Disease Rating Scale) scale and MRI parameters |
| Rate of Dependency between MRI parameters and clinical scores/questionnaires | Time of the Inclusion | Pearson, Spearman or logistic regression, depending on the MDS-UPDRS II scale and MRI parameters |
Countries
France
Contacts
STUDY_DIRECTORFrancois Cremieux
Assistance Publique - Hôpitaux de Marseille
Outcome results
None listed