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临床试验/NCT02996084
NCT02996084已完成不适用

Longitudinal Brain Volume Change (and Correlates) in Healthy Control Subjects: A Normative Sub-Study of Multiple Sclerosis Partners Advancing Technology and Health Solutions (MS PATHS)

Biogen6 个研究点 分布在 3 个国家目标入组 246 人开始时间: 2017年12月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Biogen
入组人数
246
试验地点
6
主要终点
Brain volume

研究概览

简要总结

The primary objective of this study is to determine the normative range of brain volume and brain volume change in healthy control (HC) participants whose age, race, and gender distribution is approximately matched to the age, race, and gender distribution of patients with Multiple Sclerosis (MS) enrolled in Study 888MS001. The secondary objective is to use the results of the primary endpoint to ensure consistency of brain volume measurements across MS PATHS centers.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
21 Years 至 60 Years(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

Brain volume

时间窗: Every 12 months up to 3 years

Measured by using magnetic resonance imaging (MRI) scans

Brain volume change

时间窗: Every 12 months up to 3 years

Measured by using MRI scans

次要结局

  • Development of models to calibrate brain volume measurements between centers, if necessary(Up to 3 years)

研究者

发起方
Biogen
申办方类型
Industry
责任方
Sponsor

研究点 (6)

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