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

NCT ID: NCT05976971

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-30
• Study Completion Date: 2025-12-09

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.

Conditions

REM Sleep Behaviour Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients with REM Sleep Behaviour Disorder

Group Type: OTHER

7T MRI

Intervention Type: OTHER

Subjects will have a 7T MRI and questionnaires on the only day of clinical study.

Healthy volunteers

Group Type: OTHER

7T MRI

Intervention Type: OTHER

Subjects will have a 7T MRI and questionnaires on the only day of clinical study.

Interventions

7T MRI

Subjects will have a 7T MRI and questionnaires on the only day of clinical study.

Intervention Type: OTHER

Other Intervention Names

Questionnaires

Eligibility Criteria

Inclusion Criteria

• 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.

• 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).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aix Marseille Université

OTHER

Sponsor Role: collaborator

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francois Cremieux

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Marseille

Locations

Assistance - Publique Hôpitaux de Marseille

Marseille, , France

Countries

France

Other Identifiers

ID-RCB

Identifier Type: OTHER

Identifier Source: secondary_id

RCAPHM22_0397

Identifier Type: -

Identifier Source: org_study_id