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Completed

NCT Number: NCT05976971

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

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.

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Key information

Conditions

REM Sleep Behaviour Disorder Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Mental Disorders Metabolic Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Nutritional and Metabolic Diseases Parasomnias Parkinson Disease Parkinsonian Disorders Proteostasis Deficiencies REM Sleep Behavior Disorder REM Sleep Parasomnias Sleep Wake Disorders Synucleinopathies

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance - Publique Hôpitaux de Marseille

Marseille, 13005, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

7T MRI

Other

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

Other names: Questionnaires

Primary outcomes

  1. 3D cartography the rate of difference of atrophy between the idiopathic REM Sleep Behaviour Disorder (iRBD) and control subjects

    Time frame: Time of the Inclusion

    Voxel based morphometry evaluated with Matlab and SnPM

  2. 3D cartography difference of neuromelanin between the iRBD and control subjects with T1 sequence

    Time frame: Time of the Inclusion

    Neuromelanin contrast ratio

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

    Time frame: Time of the Inclusion

    Magnetization transfert contrast ratio

  4. 3D cartography the rate of difference of Quantitative Susceptibility Mapping between the iRBD and control subjects

    Time frame: Time of the Inclusion

    Iron load evaluation in ppb

  5. 3D cartography difference of Mean diffusivity between the iRBD and control subjects

    Time frame: Time of the Inclusion

    Mean diffusivity in mm2/s

  6. 3D cartography difference of Fractional anisotropy between the iRBD and control subjects

    Time frame: Time of the Inclusion

    Fractional anisotropy between 0 and 1

Secondary outcomes

  1. 3D cartography difference of total sodium concentration between the iRBD and control subjects

    Time frame: Time of the Inclusion

    total sodium concentration in mmol/L acquired with a specificic MRI coil

  2. 3D cartography difference of structural brain connectivity between the iRBD and control subjects

    Time frame: Time of the Inclusion

    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.

  3. Rate of Dependency between MRI parameters and demographic data

    Time frame: Time of the Inclusion

    Pearson, Spearman or logistic regression, depending on the age and MRI parameters

  4. Rate of Dependency between MRI parameters and demographic data

    Time frame: Time of the Inclusion

    Pearson, Spearman or logistic regression, depending on the sex and MRI parameters

  5. Rate of Dependency between MRI parameters and demographic data

    Time frame: Time of the Inclusion

    Pearson, Spearman or logistic regression, depending on the laterality and MRI parameters

  6. Rate of Dependency between MRI parameters and demographic data, clinical scores/questionnaires

    Time frame: Time of the Inclusion

    Pearson, Spearman or logistic regression, depending on the MDS-UPDRS I (Movement disorders society - Unified Parkinson's Disease Rating Scale) scale and MRI parameters

  7. Rate of Dependency between MRI parameters and clinical scores/questionnaires

    Time frame: Time of the Inclusion

    Pearson, Spearman or logistic regression, depending on the MDS-UPDRS II scale and MRI parameters

  8. Rate of Dependency between MRI parameters and clinical scores/questionnaires

    Time frame: Time of the Inclusion

    Pearson, Spearman or logistic regression, depending on the MDS-UPDRS III scale and MRI parameters

  9. Rate of Dependency between MRI parameters and clinical scores/questionnaires

    Time frame: Time of the Inclusion

    Pearson, Spearman or logistic regression, depending on the SCOPA-AUT scale and MRI parameters

  10. Rate of Dependency between MRI parameters and clinical scores/questionnaires

    Time frame: Time of the Inclusion

    Pearson, Spearman or logistic regression, depending on the HAD scale (Hospital Anxiety and Depression scale) and MRI parameters

  11. Rate of Dependency between MRI parameters and clinical scores/questionnaires

    Time frame: Time of the Inclusion

    Pearson, Spearman or logistic regression, depending on the RBD (Rem sleep behaviour disorder) and MRI parameters

  12. Rate of Dependency between MRI parameters and demographic data, clinical scores/questionnaires

    Time frame: Time of the Inclusion

    Pearson, Spearman or logistic regression, depending on the Pittsburgh sleep quality index and MRI parameters

  13. Rate of Dependency between MRI parameters and clinical scores/questionnaires

    Time frame: Time of the Inclusion

    Pearson, Spearman or logistic regression, depending on the Starkstein motivation scale and MRI parameters

  14. Rate of Dependency between MRI parameters and clinical scores/questionnaires

    Time frame: Time of the Inclusion

    Pearson, Spearman or logistic regression, depending on the non motor fluctuation scale and MRI parameters

  15. Rate of Dependency between MRI parameters and clinical scores/questionnaires

    Time frame: Time of the Inclusion

    Pearson, Spearman or logistic regression, depending on the MoCA scale and MRI parameters

  16. Rate of Dependency between MRI parameters and clinical scores/questionnaires

    Time frame: Time of the Inclusion

    Pearson, Spearman or logistic regression, depending on the phonemic and category fluencies and MRI parameters

  17. Rate of Dependency between MRI parameters and clinical scores/questionnaires

    Time frame: Time of the Inclusion

    Pearson, Spearman or logistic regression, depending on the Benton judgement of lines and MRI parameters

  18. Rate of Dependency between MRI parameters and clinical scores/questionnaires

    Time frame: Time of the Inclusion

    Pearson, Spearman or logistic regression, depending on the quality of life SF-36 and MRI parameters

  19. Rate of Dependency between MRI parameters and clinical scores/questionnaires

    Time frame: Time of the Inclusion

    Pearson, Spearman or logistic regression, depending on the Miami Hallucinations questionnaire and MRI parameters

  20. Rate of Dependency between MRI parameters and clinical scores/questionnaires

    Time frame: Time of the Inclusion

    Pearson, Spearman or logistic regression, depending on the treatement intake and MRI parameters

  21. Rate of Dependency between MRI parameters and clinical scores/questionnaires

    Time frame: Time of the Inclusion

    Pearson, Spearman or logistic regression, depending on the blood pressure test and MRI parameters

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Collaborators

  • Aix Marseille Université

Registry information

Official study title

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

Acronym: SODISLEEP

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 4, 2023
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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