An interventional study of 7T MRI in REM Sleep Behaviour Disorder, sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to participants aged 40 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Diagnostic
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.
101 studies on the registry are indexed under REM Sleep Behavior Disorder; 45 are open to participants now.
This study's enrollment of 31 is below the median of 42 across 50 interventional studies indexed under REM Sleep Behavior Disorder.
Browse REM Sleep Behavior Disorder studies →Assistance Publique Hopitaux De Marseille is the lead sponsor of 702 studies on the registry; 139 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Inclusion Criteria for patients with REM Sleep Behaviour Disorder :
Inclusion Criteria for control group :
Exclusion Criteria :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: 7T MRI
Other: 7T MRI
Subjects will have a 7T MRI and questionnaires on the only day of clinical study.
Also known as: Questionnaires
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 frame: Time of the Inclusion
3D cartography difference of neuromelanin between the iRBD and control subjects with T1 sequence
Neuromelanin contrast ratio
Time frame: Time of the Inclusion
3D cartography difference of neuromelanin between the iRBD and control subjects with Magnetization transfert sequence
Magnetization transfert contrast ratio
Time frame: 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 frame: Time of the Inclusion
3D cartography difference of Mean diffusivity between the iRBD and control subjects
Mean diffusivity in mm2/s
Time frame: Time of the Inclusion
3D cartography difference of Fractional anisotropy between the iRBD and control subjects
Fractional anisotropy between 0 and 1
Time frame: Time of the Inclusion
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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: Time of the Inclusion
Plan to share: No
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Ran from Oct 2023 to primary completion in Dec 2025, 25 months.
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This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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