Microstructural and Sodium 7 Tesla Brain MRI in Idiopathic REM Sleep Behaviour Disorder

Not Applicable

Recruiting

• Conditions: REM Sleep Behaviour Disorder
• Interventions: Other: 7T MRI

• Registration Number: NCT05976971
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-12
• Study First Submitted QC: 2023-07-27
• Study First Posted: 2023-08-04
• Status Verified: 2023-10
• Study Start: 2023-10-30
• Last Update Submitted: 2023-10-30
• Last Update Posted: 2023-10-31
• Primary Completion: 2025-10-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with REM Sleep Behaviour Disorder	7T MRI	-
Healthy volunteers	7T MRI	-

Primary Outcome Measures

Name	Time	Method
3D cartography difference of Fractional anisotropy between the iRBD and control subjects	Time of the Inclusion	Fractional anisotropy between 0 and 1
3D cartography difference of Mean diffusivity between the iRBD and control subjects	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	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

Secondary Outcome Measures

Name	Time	Method
Rate of Dependency between MRI parameters and clinical scores/questionnaires	Time of the Inclusion	Pearson, Spearman or logistic regression, depending on the blood pressure test and MRI parameters
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 laterality 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 Pittsburgh sleep quality index and MRI parameters

Trial Locations

Locations (1)

Assistance - Publique Hôpitaux de Marseille; 🇫🇷 Marseille, France