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

January 16, 2026 updated by: Assistance Publique Hopitaux De Marseille

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: Time of the Inclusion
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
Time Frame: Time of the Inclusion
Neuromelanin contrast ratio
Time of the Inclusion
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
Time of the Inclusion
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
Time of the Inclusion
3D cartography difference of Mean diffusivity between the iRBD and control subjects
Time Frame: Time of the Inclusion
Mean diffusivity in mm2/s
Time of the Inclusion
3D cartography difference of Fractional anisotropy between the iRBD and control subjects
Time Frame: Time of the Inclusion
Fractional anisotropy between 0 and 1
Time of the Inclusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Time of the Inclusion
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.
Time of the Inclusion
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
Time of the Inclusion
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
Time of the Inclusion
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
Time of the Inclusion
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
Time of the Inclusion
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
Time of the Inclusion
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
Time of the Inclusion
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
Time of the Inclusion
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
Time of the Inclusion
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
Time of the Inclusion
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
Time of the Inclusion
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
Time of the Inclusion
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
Time of the Inclusion
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
Time of the Inclusion
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
Time of the Inclusion
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
Time of the Inclusion
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
Time of the Inclusion
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
Time of the Inclusion
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
Time of the Inclusion
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
Time of the Inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assistance Publique Hopitaux De Marseille

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Aix Marseille Université

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: François Crémieux, Assistance Publique - Hopitaux de Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 30, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 9, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 9, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 4, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RCAPHM22_0397
  • ID-RCB (Other Identifier: 2023-A01756-39)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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