Ignite Creation Date:
2024-05-06 @ 7:20 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05976971
Status:
RECRUITING
Last Update Posted:
2023-10-31
First Post:
2023-07-12
Brief Title:
Microstructural and Sodium 7 Tesla Brain MRI in Idiopathic REM Sleep Behaviour Disorder
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
Study Overview
Official Title:
Microstructural Brain MRI Biomarkers in Patients With Idiopathic REM Sleep Behaviour Disorder at 7 Tesla
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SODISLEEP
Brief Summary:
By 2030 the number of patients with Parkinsons 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ID-RCB | OTHER | 2023-A00457-38 | None |