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

Primary Purpose

REM Sleep Behaviour Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
7T MRI
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for REM Sleep Behaviour Disorder focused on measuring 7T MRI, Parkinson's disease, synucleinopathies

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Assistance - Publique Hôpitaux de Marseille

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Patients with REM Sleep Behaviour Disorder

Healthy volunteers

Arm Description

Outcomes

Primary Outcome Measures

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
3D cartography difference of neuromelanin between the iRBD and control subjects with T1 sequence
Neuromelanin contrast ratio
3D cartography difference of neuromelanin between the iRBD and control subjects with Magnetization transfert sequence
Magnetization transfert contrast ratio
3D cartography the rate of difference of Quantitative Susceptibility Mapping between the iRBD and control subjects
Iron load evaluation in ppb
3D cartography difference of Mean diffusivity between the iRBD and control subjects
Mean diffusivity in mm2/s
3D cartography difference of Fractional anisotropy between the iRBD and control subjects
Fractional anisotropy between 0 and 1

Secondary Outcome Measures

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
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.
Rate of Dependency between MRI parameters and demographic data
Pearson, Spearman or logistic regression, depending on the age and MRI parameters
Rate of Dependency between MRI parameters and demographic data
Pearson, Spearman or logistic regression, depending on the sex and MRI parameters
Rate of Dependency between MRI parameters and demographic data
Pearson, Spearman or logistic regression, depending on the laterality and MRI parameters
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
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
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
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Pearson, Spearman or logistic regression, depending on the SCOPA-AUT scale and MRI parameters
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
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
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
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Pearson, Spearman or logistic regression, depending on the Starkstein motivation scale and MRI parameters
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
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Pearson, Spearman or logistic regression, depending on the MoCA scale and MRI parameters
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
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
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
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Pearson, Spearman or logistic regression, depending on the Miami Hallucinations questionnaire and MRI parameters
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Pearson, Spearman or logistic regression, depending on the treatement intake and MRI parameters
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Pearson, Spearman or logistic regression, depending on the blood pressure test and MRI parameters

Full Information

First Posted
July 12, 2023
Last Updated
July 27, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
Collaborators
Aix Marseille Université
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1. Study Identification

Unique Protocol Identification Number
NCT05976971
Brief Title
Microstructural and Sodium 7 Tesla Brain MRI in Idiopathic REM Sleep Behaviour Disorder
Acronym
SODISLEEP
Official Title
Microstructural Brain MRI Biomarkers in Patients With Idiopathic REM Sleep Behaviour Disorder at 7 Tesla
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
September 30, 2025 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
Collaborators
Aix Marseille Université

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
REM Sleep Behaviour Disorder
Keywords
7T MRI, Parkinson's disease, synucleinopathies

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with REM Sleep Behaviour Disorder
Arm Type
Other
Arm Title
Healthy volunteers
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
7T MRI
Other Intervention Name(s)
Questionnaires
Intervention Description
Subjects will have a 7T MRI and questionnaires on the only day of clinical study.
Primary Outcome Measure Information:
Title
3D cartography the rate of difference of atrophy between the idiopathic REM Sleep Behaviour Disorder (iRBD) and control subjects
Description
Voxel based morphometry evaluated with Matlab and SnPM
Time Frame
Time of the Inclusion
Title
3D cartography difference of neuromelanin between the iRBD and control subjects with T1 sequence
Description
Neuromelanin contrast ratio
Time Frame
Time of the Inclusion
Title
3D cartography difference of neuromelanin between the iRBD and control subjects with Magnetization transfert sequence
Description
Magnetization transfert contrast ratio
Time Frame
Time of the Inclusion
Title
3D cartography the rate of difference of Quantitative Susceptibility Mapping between the iRBD and control subjects
Description
Iron load evaluation in ppb
Time Frame
Time of the Inclusion
Title
3D cartography difference of Mean diffusivity between the iRBD and control subjects
Description
Mean diffusivity in mm2/s
Time Frame
Time of the Inclusion
Title
3D cartography difference of Fractional anisotropy between the iRBD and control subjects
Description
Fractional anisotropy between 0 and 1
Time Frame
Time of the Inclusion
Secondary Outcome Measure Information:
Title
3D cartography difference of total sodium concentration between the iRBD and control subjects
Description
total sodium concentration in mmol/L acquired with a specificic MRI coil
Time Frame
Time of the Inclusion
Title
3D cartography difference of structural brain connectivity between the iRBD and control subjects
Description
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
Title
Rate of Dependency between MRI parameters and demographic data
Description
Pearson, Spearman or logistic regression, depending on the age and MRI parameters
Time Frame
Time of the Inclusion
Title
Rate of Dependency between MRI parameters and demographic data
Description
Pearson, Spearman or logistic regression, depending on the sex and MRI parameters
Time Frame
Time of the Inclusion
Title
Rate of Dependency between MRI parameters and demographic data
Description
Pearson, Spearman or logistic regression, depending on the laterality and MRI parameters
Time Frame
Time of the Inclusion
Title
Rate of Dependency between MRI parameters and demographic data, clinical scores/questionnaires
Description
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
Title
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Description
Pearson, Spearman or logistic regression, depending on the MDS-UPDRS II scale and MRI parameters
Time Frame
Time of the Inclusion
Title
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Description
Pearson, Spearman or logistic regression, depending on the MDS-UPDRS III scale and MRI parameters
Time Frame
Time of the Inclusion
Title
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Description
Pearson, Spearman or logistic regression, depending on the SCOPA-AUT scale and MRI parameters
Time Frame
Time of the Inclusion
Title
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Description
Pearson, Spearman or logistic regression, depending on the HAD scale (Hospital Anxiety and Depression scale) and MRI parameters
Time Frame
Time of the Inclusion
Title
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Description
Pearson, Spearman or logistic regression, depending on the RBD (Rem sleep behaviour disorder) and MRI parameters
Time Frame
Time of the Inclusion
Title
Rate of Dependency between MRI parameters and demographic data, clinical scores/questionnaires
Description
Pearson, Spearman or logistic regression, depending on the Pittsburgh sleep quality index and MRI parameters
Time Frame
Time of the Inclusion
Title
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Description
Pearson, Spearman or logistic regression, depending on the Starkstein motivation scale and MRI parameters
Time Frame
Time of the Inclusion
Title
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Description
Pearson, Spearman or logistic regression, depending on the non motor fluctuation scale and MRI parameters
Time Frame
Time of the Inclusion
Title
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Description
Pearson, Spearman or logistic regression, depending on the MoCA scale and MRI parameters
Time Frame
Time of the Inclusion
Title
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Description
Pearson, Spearman or logistic regression, depending on the phonemic and category fluencies and MRI parameters
Time Frame
Time of the Inclusion
Title
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Description
Pearson, Spearman or logistic regression, depending on the Benton judgement of lines and MRI parameters
Time Frame
Time of the Inclusion
Title
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Description
Pearson, Spearman or logistic regression, depending on the quality of life SF-36 and MRI parameters
Time Frame
Time of the Inclusion
Title
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Description
Pearson, Spearman or logistic regression, depending on the Miami Hallucinations questionnaire and MRI parameters
Time Frame
Time of the Inclusion
Title
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Description
Pearson, Spearman or logistic regression, depending on the treatement intake and MRI parameters
Time Frame
Time of the Inclusion
Title
Rate of Dependency between MRI parameters and clinical scores/questionnaires
Description
Pearson, Spearman or logistic regression, depending on the blood pressure test and MRI parameters
Time Frame
Time of the Inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandre Eusebio, MD, PhD
Phone
0491384360
Ext
33
Email
alexandre.eusebio@ap-hm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Grimaldi Stephan
Email
stephan.grimaldi@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francois Cremieux
Organizational Affiliation
Assistance Publique - Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance - Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre Eusebio
Email
Alexandre.eusebio@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Stephan Grimaldi
Email
stephan.grimaldi@ap-hm.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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

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