Status:
UNKNOWN
Microstructural and Sodium 7 Tesla Brain MRI in Idiopathic REM Sleep Behaviour Disorder
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Collaborating Sponsors:
Aix Marseille Université
Conditions:
REM Sleep Behaviour Disorder
Eligibility:
All Genders
40-80 years
Phase:
NA
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 s...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
October 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2025
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT05976971
Start Date
October 30 2023
End Date
October 30 2025
Last Update
October 31 2023
Active Locations (1)
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1
Assistance - Publique Hôpitaux de Marseille
Marseille, France, 13005