Clinical trial NCT05976971: Microstructural and Sodium 7 Tesla Brain MRI in Idiopathic REM Sleep Behaviour Disorder
Official title: Microstructural Brain MRI Biomarkers in Patients With Idiopathic REM Sleep Behaviour Disorder at 7 Tesla
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: REM Sleep Behaviour Disorder
Keywords: 7T MRI
Parkinson's disease
synucleinopathies
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
Collaborators: name: Aix Marseille Université
First posted: 2023-08-04
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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).

Primary outcomes:
measure: 3D cartography the rate of difference of atrophy between the idiopathic REM Sleep Behaviour Disorder (iRBD) and control subjects
timeFrame: Time of the Inclusion
measure: 3D cartography difference of neuromelanin between the iRBD and control subjects with T1 sequence
timeFrame: Time of the Inclusion
measure: 3D cartography difference of neuromelanin between the iRBD and control subjects with Magnetization transfert sequence
timeFrame: Time of the Inclusion
measure: 3D cartography the rate of difference of Quantitative Susceptibility Mapping between the iRBD and control subjects
timeFrame: Time of the Inclusion
measure: 3D cartography difference of Mean diffusivity between the iRBD and control subjects
timeFrame: Time of the Inclusion
measure: 3D cartography difference of Fractional anisotropy between the iRBD and control subjects
timeFrame: Time of the Inclusion
Secondary outcomes:
measure: 3D cartography difference of total sodium concentration between the iRBD and control subjects
timeFrame: Time of the Inclusion
measure: 3D cartography difference of structural brain connectivity between the iRBD and control subjects
timeFrame: Time of the Inclusion
measure: Rate of Dependency between MRI parameters and demographic data
timeFrame: Time of the Inclusion
measure: Rate of Dependency between MRI parameters and demographic data
timeFrame: Time of the Inclusion
measure: Rate of Dependency between MRI parameters and demographic data
timeFrame: Time of the Inclusion
measure: Rate of Dependency between MRI parameters and demographic data, clinical scores/questionnaires
timeFrame: Time of the Inclusion
measure: Rate of Dependency between MRI parameters and clinical scores/questionnaires
timeFrame: Time of the Inclusion
measure: Rate of Dependency between MRI parameters and clinical scores/questionnaires
timeFrame: Time of the Inclusion
measure: Rate of Dependency between MRI parameters and clinical scores/questionnaires
timeFrame: Time of the Inclusion
measure: Rate of Dependency between MRI parameters and clinical scores/questionnaires
timeFrame: Time of the Inclusion
measure: Rate of Dependency between MRI parameters and clinical scores/questionnaires
timeFrame: Time of the Inclusion
measure: Rate of Dependency between MRI parameters and demographic data, clinical scores/questionnaires
timeFrame: Time of the Inclusion
measure: Rate of Dependency between MRI parameters and clinical scores/questionnaires
timeFrame: Time of the Inclusion
measure: Rate of Dependency between MRI parameters and clinical scores/questionnaires
timeFrame: Time of the Inclusion
measure: Rate of Dependency between MRI parameters and clinical scores/questionnaires
timeFrame: Time of the Inclusion
measure: Rate of Dependency between MRI parameters and clinical scores/questionnaires
timeFrame: Time of the Inclusion
measure: Rate of Dependency between MRI parameters and clinical scores/questionnaires
timeFrame: Time of the Inclusion
measure: Rate of Dependency between MRI parameters and clinical scores/questionnaires
timeFrame: Time of the Inclusion
measure: Rate of Dependency between MRI parameters and clinical scores/questionnaires
timeFrame: Time of the Inclusion
measure: Rate of Dependency between MRI parameters and clinical scores/questionnaires
timeFrame: Time of the Inclusion
measure: Rate of Dependency between MRI parameters and clinical scores/questionnaires
timeFrame: Time of the Inclusion
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance - Publique Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique - Hôpitaux de Marseille
name: Francois Cremieux
role: STUDY_DIRECTOR
References: