Investigating brain changes in patients with REM Sleep Behaviour Disorder using advanced MRI

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

This study is testing how the brains of people with REM Sleep Behavior Disorder differ from those of healthy individuals using advanced MRI technology to help understand the condition better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: Assistance Publique Hopitaux De Marseille (other)
• Locations: 1 site (Marseille)
• Trial ID: NCT05976971 on ClinicalTrials.gov

What this trial studies

This study aims to explore the microstructural and sodium changes in the brains of individuals diagnosed with idiopathic REM Sleep Behaviour Disorder (RBD) using 7 Tesla MRI technology. By comparing 15 patients with isolated RBD to 15 healthy controls, the researchers hope to uncover differences in brain structure and connectivity that may be linked to the disorder. The study will involve detailed imaging and analysis to better understand the pathophysiology of RBD, which is often a precursor to Parkinson's Disease. Participants will undergo non-invasive MRI scans to assess these brain changes.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 40 to 80 who have been diagnosed with REM Sleep Behaviour Disorder and meet specific clinical criteria.

Not a fit: Patients with a history of central nervous system diseases such as Parkinson's Disease or Alzheimer's Disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this research could lead to improved understanding and early detection of Parkinson's Disease and related disorders in patients with RBD.

How similar studies have performed: While the use of 7 Tesla MRI is a cutting-edge approach, similar studies have shown promise in understanding neurodegenerative disorders, making this a potentially impactful investigation.

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).

Where this trial is running

Marseille

• Assistance - Publique Hôpitaux de Marseille — Marseille, France (RECRUITING)

Study contacts

• Study coordinator: Alexandre Eusebio, MD, PhD

Conditions: REM Sleep Behaviour Disorder, 7T MRI, Parkinson's disease, synucleinopathies