跳至主要内容
临床试验/NCT05967832
NCT05967832招募中不适用

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

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年1月29日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Hypothalamic morphological difference

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Hypothalamic morphological difference

时间窗: Month 0

Significant structural size difference between right and left lateral hypothalamus

次要结局

  • Structural changes in hypothalamic nuclei other than the lateral hypothalamus(Month 0)
  • Microstructural abnormalities other than volume differences(Month 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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