Contribution of 7 Tesla MRI of the Hypothalamus in the Diagnosis of Type 1 Narcolepsy

Not Applicable

Recruiting

• Conditions: Narcolepsy Type 1

• Registration Number: NCT05967832
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-23
• Study First Submitted QC: 2023-07-22
• Study First Posted: 2023-08-01
• Status Verified: 2024-01
• Study Start: 2024-01-29
• Last Update Submitted: 2024-01-31
• Last Update Posted: 2024-02-01
• Primary Completion: 2026-01-29
• Study Completion: 2026-01-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hypothalamic morphological difference	Month 0	Significant structural size difference between right and left lateral hypothalamus

Secondary Outcome Measures

Name	Time	Method
Structural changes in hypothalamic nuclei other than the lateral hypothalamus	Month 0	Significant difference in volumes and T1 values in other regions of the posterior hypothalamus
Microstructural abnormalities other than volume differences	Month 0	Significant difference in Diffusion and T2\* values in the lateral hypothalamus

Trial Locations

Locations (1)

Service Epileptologie et Rythmologie Cérébrale, Centre du Sommeil; 🇫🇷 Marseille, France