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)
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
- 是
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
研究点 (6)
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