NCT05976971Completed
Microstructural and Sodium 7 Tesla Brain MRI in Idiopathic REM Sleep Behaviour Disorder
Microstructural Brain MRI Biomarkers in Patients With Idiopathic REM Sleep Behaviour Disorder at 7 Tesla
Source: ClinicalTrials.gov · Last updated 21 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 31 (actual)
- First submitted
- 12 Jul 2023
- Start date
- 30 Oct 2023
- Primary completion date
- 9 Dec 2025
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Diseases
- Parkinson disease
- NCT number
- NCT05976971
What you commit to
- Study type: Interventional
- Participants enrolled: 31
- From 30 Oct 2023 to the primary completion date, 9 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Claustrophobia.
- Montreal Cognitive Assessment Test (MOCA) \< 25/30
- Pregnant or breast-feeding woman or protected person (under guardianship, curatorship, deprived of liberty).
Who the study is looking for
- 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.
Age in the registry: 40 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Assistance Publique Hôpitaux de Marseille Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.