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

Microstructural Brain MRI Biomarkers in Patients With Idiopathic REM Sleep Behaviour Disorder at 7 Tesla

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.

Study Overview

• Status: Completed
• Conditions: REM Sleep Behaviour Disorder
• Intervention / Treatment: Other: 7T MRI

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13005
    • Assistance - Publique Hôpitaux de Marseille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthy volunteers	Other: 7T MRI; Subjects will have a 7T MRI and questionnaires on the only day of clinical study.; Other Names: Questionnaires
Other: Patients with REM Sleep Behaviour Disorder	Other: 7T MRI; Subjects will have a 7T MRI and questionnaires on the only day of clinical study.; Other Names: Questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
3D cartography difference of total sodium concentration between the iRBD and control subjects	total sodium concentration in mmol/L acquired with a specificic MRI coil	Time of the Inclusion
3D cartography difference of structural brain connectivity between the iRBD and control subjects	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.	Time of the Inclusion
Rate of Dependency between MRI parameters and demographic data	Pearson, Spearman or logistic regression, depending on the age and MRI parameters	Time of the Inclusion
Rate of Dependency between MRI parameters and demographic data	Pearson, Spearman or logistic regression, depending on the sex and MRI parameters	Time of the Inclusion
Rate of Dependency between MRI parameters and demographic data	Pearson, Spearman or logistic regression, depending on the laterality and MRI parameters	Time of the Inclusion
Rate of Dependency between MRI parameters and demographic data, clinical scores/questionnaires	Pearson, Spearman or logistic regression, depending on the MDS-UPDRS I (Movement disorders society - Unified Parkinson's Disease Rating Scale) scale and MRI parameters	Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires	Pearson, Spearman or logistic regression, depending on the MDS-UPDRS II scale and MRI parameters	Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires	Pearson, Spearman or logistic regression, depending on the MDS-UPDRS III scale and MRI parameters	Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires	Pearson, Spearman or logistic regression, depending on the SCOPA-AUT scale and MRI parameters	Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires	Pearson, Spearman or logistic regression, depending on the HAD scale (Hospital Anxiety and Depression scale) and MRI parameters	Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires	Pearson, Spearman or logistic regression, depending on the RBD (Rem sleep behaviour disorder) and MRI parameters	Time of the Inclusion
Rate of Dependency between MRI parameters and demographic data, clinical scores/questionnaires	Pearson, Spearman or logistic regression, depending on the Pittsburgh sleep quality index and MRI parameters	Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires	Pearson, Spearman or logistic regression, depending on the Starkstein motivation scale and MRI parameters	Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires	Pearson, Spearman or logistic regression, depending on the non motor fluctuation scale and MRI parameters	Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires	Pearson, Spearman or logistic regression, depending on the MoCA scale and MRI parameters	Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires	Pearson, Spearman or logistic regression, depending on the phonemic and category fluencies and MRI parameters	Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires	Pearson, Spearman or logistic regression, depending on the Benton judgement of lines and MRI parameters	Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires	Pearson, Spearman or logistic regression, depending on the quality of life SF-36 and MRI parameters	Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires	Pearson, Spearman or logistic regression, depending on the Miami Hallucinations questionnaire and MRI parameters	Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires	Pearson, Spearman or logistic regression, depending on the treatement intake and MRI parameters	Time of the Inclusion
Rate of Dependency between MRI parameters and clinical scores/questionnaires	Pearson, Spearman or logistic regression, depending on the blood pressure test and MRI parameters	Time of the Inclusion

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Collaborators: Aix Marseille Université
• Investigators: Study Director: François Crémieux, Assistance Publique - Hopitaux de Marseille

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2023
• Primary Completion (Actual): December 9, 2025
• Study Completion (Actual): December 9, 2025

Study Registration Dates

• First Submitted: July 12, 2023
• First Submitted That Met QC Criteria: July 27, 2023
• First Posted (Actual): August 4, 2023

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Parkinson's disease; synucleinopathies; 7T MRI
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Metabolic Diseases; Neurodegenerative Diseases; Sleep Wake Disorders; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Proteostasis Deficiencies; Parasomnias; REM Sleep Parasomnias; Nutritional and Metabolic Diseases; Synucleinopathies; Parkinson Disease; REM Sleep Behavior Disorder; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: RCAPHM22_0397; ID-RCB (Other Identifier: 2026-A00289-42)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No