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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: t
View:

• 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.

• 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.

Locations
Other Locations
France
Assistance - Publique Hôpitaux de Marseille
RECRUITING
Marseille
Contact Information
Primary
Alexandre Eusebio, MD, PhD
alexandre.eusebio@ap-hm.fr
0491384360
Backup
Grimaldi Stephan
stephan.grimaldi@ap-hm.fr
Time Frame
Start Date: 2023-10-30
Estimated Completion Date: 2025-10-30
Participants
Target number of participants: 32
Treatments
Other: Patients with REM Sleep Behaviour Disorder
Other: Healthy volunteers
Sponsors
Leads: Assistance Publique Hopitaux De Marseille
Collaborators: Aix Marseille Université

This content was sourced from clinicaltrials.gov