NCT05106465已完成不适用
Konect-MF: A Study to Explore Association Patterns Between Digital Outcome Assessments From the Konectom™ Platform and MRI Measures of Brain Tissue Damage
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
- 200
- 试验地点
- 1
- 主要终点
- Correlation Between Konectom Tests and MRI Measures of Brain Tissue Damage
研究概览
简要总结
The purpose of the study is to explore association patterns between digital outcome assessments from Konectom and MRI measures of brain tissue damage.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Should be enrolled in multiple sclerosis partners advancing technology and health solutions (MS PATHS).
- •Participant (or participant's legal representative) has the ability to understand the purpose and risks of the study, to provide signed and dated informed consent, and to authorize the use of confidential health information in accordance with national and local privacy regulations.
- •Should have literacy of written language in which the software and Instructions for use are displayed (User Interface [UI], Instructions).
排除标准
- •Unable or unwilling to provide informed consent.
- •Inability to use a smartphone as per physician's opinion.
- •Not owning a Konectom-compatible smartphone.
- •Other unspecified reasons that, in the opinion of the Investigator or Biogen, make the participant unsuitable for participation in the sub-study. A participant only needs to complete the assessments deemed necessary by the Investigator.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
结局指标
主要结局
Correlation Between Konectom Tests and MRI Measures of Brain Tissue Damage
时间窗: Up to 1 year
Konectom tests include cognitive processing speed test (CPST), pinching test, drawing test, static balance test (SBT)/u-turn test (UTT) and 6-minute walking test (6MWT).
次要结局
- Correlation Between Konectom Tests and Deep Radiomic Feature Set Extracted From the Normal Appearing White Matter Using 3D-T1 and 3D FLAIR Data(Up to 1 year)
- Correlation Between Konectom Tests and Deep Radiomic Feature Set Extracted From the Cortex Using 3D-T1 and 3D FLAIR Data(Up to 1 year)
- Correlation Between Konectom Tests and Deep Radiomic Feature Set Extracted From Fluid-attenuated Inversion Recovery (FLAIR) Hyperintense MS Lesions Using 3D-T1 and 3D FLAIR Data(Up to 1 year)
- Correlation Between Konectom Tests and Deep Radiomic Feature Set Extracted From Deep Grey Matter Using 3D-T1 and 3D FLAIR Data(Up to 1 year)
研究者
研究点 (1)
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