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

NCT05976971 | Completed

• 2 other identifiers: RCAPHM22_0397ID-RCB
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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

Keywords

7T MRI; Parkinson's disease; synucleinopathies

Outcome Measures

Primary Outcomes (6)

• 3D cartography the rate of difference of atrophy between the idiopathic REM Sleep Behaviour Disorder (iRBD) and control subjects

  Voxel based morphometry evaluated with Matlab and SnPM

  Time of the Inclusion

• 3D cartography difference of neuromelanin between the iRBD and control subjects with T1 sequence

  Neuromelanin contrast ratio

  Time of the Inclusion

• 3D cartography difference of neuromelanin between the iRBD and control subjects with Magnetization transfert sequence

  Magnetization transfert contrast ratio

  Time of the Inclusion

• 3D cartography the rate of difference of Quantitative Susceptibility Mapping between the iRBD and control subjects

  Iron load evaluation in ppb

  Time of the Inclusion

• 3D cartography difference of Mean diffusivity between the iRBD and control subjects

  Mean diffusivity in mm2/s

  Time of the Inclusion

• 3D cartography difference of Fractional anisotropy between the iRBD and control subjects

  Fractional anisotropy between 0 and 1

  Time of the Inclusion

Secondary Outcomes (21)

• 3D cartography difference of total sodium concentration between the iRBD and control subjects

  Time of the Inclusion

• 3D cartography difference of structural brain connectivity between the iRBD and control subjects

  Time of the Inclusion

• Rate of Dependency between MRI parameters and demographic data

  Time of the Inclusion

• Rate of Dependency between MRI parameters and demographic data

  Time of the Inclusion

• Rate of Dependency between MRI parameters and demographic data

  Time of the Inclusion

Study Arms (2)

Patients with REM Sleep Behaviour Disorder

OTHER

Other: 7T MRI

Healthy volunteers

OTHER

Other: 7T MRI

Interventions

7T MRI OTHER

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

Also known as: Questionnaires

Healthy volunteers; Patients with REM Sleep Behaviour Disorder

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Aix Marseille Université: collaborator
• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance - Publique Hôpitaux de Marseille

Marseille, 13005, France

Location

MeSH Terms

Conditions

REM Sleep Behavior Disorder; Parkinson Disease; Synucleinopathies

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Francois Cremieux

  Assistance Publique - Hôpitaux de Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: August 4, 2023
• Study Start: October 30, 2023
• Primary Completion: December 9, 2025
• Study Completion: December 9, 2025
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)