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| ID | Type | Description | Link |
|---|---|---|---|
| ID-RCB | Other Identifier | 2022-A02674-39 |
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This study is part of the research on type 1 narcolepsy, a neurological pathology affecting mostly young subjects. The only biomarker currently available is the hypocretin assay, which shows a level below 110 pg/mL. However, the interpretation of this biomarker has limitations: the test is not widely available and it is rarely performed by practitioners. Even when performed, the interpretation of the level may not be consistent with the phenotype compatible with type 1 narcolepsy.
This study therefore aims to develop new tools to reduce the diagnostic delay. This would be the first study with 7T MRI that could achieve a level of spatial resolution sufficient to highlight volume changes in small brain structures such as the lateral hypothalamus whose narcolepsy-induced changes are not detected by lower resolution MRI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with type 1 narcolepsy | Experimental | Patients with type 1 narcolepsy |
|
| Healthy volunteers | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 7T MRI | Other | Patients and healthy volunteers will have a 7T MRI |
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| Measure | Description | Time Frame |
|---|---|---|
| Hypothalamic morphological difference | Significant structural size difference between right and left lateral hypothalamus | Month 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Microstructural abnormalities other than volume differences | Significant difference in Diffusion and T2* values in the lateral hypothalamus | Month 0 |
| Structural changes in hypothalamic nuclei other than the lateral hypothalamus |
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Inclusion Criteria for patients :
Exclusion Criteria for patient:
Inclusion criteria for healthy volunteers:
Exclusion criteria for healthy volunteers:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isabelle LAMBERT, MD, PhD | Contact | 04 91 38 47 76 | 33 | isabelle.lambert@ap-hm.fr |
| Name | Affiliation | Role |
|---|---|---|
| François Crémieux | AP-HM | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service Epileptologie et Rythmologie Cérébrale, Centre du Sommeil | Recruiting | Marseille | 13005 | France |
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| ID | Term |
|---|---|
| D009290 | Narcolepsy |
| ID | Term |
|---|---|
| D006970 | Disorders of Excessive Somnolence |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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Significant difference in volumes and T1 values in other regions of the posterior hypothalamus
| Month 0 |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |