Advanced MRI Applications for Mild Traumatic Brain Injury - Study 3
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- mTBI Progression Indicated by Clinical Neurological Characteristics, MRI Images, and Quantitative MRI Data From Novel Software
研究概览
简要总结
This hypothesis-generating feasibility study to determine potential associations between a broad range of clinical neurological symptoms and Magnetic Resonance Image (MRI), data, and clinical findings involved in mild traumatic brain injury (mTBI). These associations will be examined over the acute and sub-acute period (baseline to 3 months) following injury to provide information useful for optimization of MR pulse sequences for mTBI applications.
The intent of this study is to broadly generate a range of potential mTBI biomarkers detectable using investigational MR pulse sequence technologies. Feasibility data attained in this study may be used for engineering program decision-making and in support of future scientific assessment, engineering development, published research databases or registries mTBI data and images, and other purposes determined by the Sponsor. The results of this study are not intended for use in regulatory submissions.
Subjects will be examined on commercially available MR scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MR pulse sequences optimized by Sponsor
详细描述
This hypothesis-generating feasibility study is being conducted to determine potential associations between a broad range of clinical neurological symptoms and MR images, data, and clinical findings involved in mild traumatic brain injury (mTBI). These associations will be examined over the acute and sub-acute period (approximately 3 months) following injury to provide information useful for optimization of MR pulse sequences for mTBI applications.
The intent of this study is to broadly generate a range of potential mTBI biomarkers detectable using investigational MR pulse sequence technologies. Feasibility data attained in this study may be used for engineering program decision-making and in support of future scientific assessment, engineering development, published research databases or registries mTBI data and images, and other purposes determined by the Sponsor. The results of this study are not intended for use in regulatory submissions.
Subjects will be examined on commercially available MR scanners using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MR pulse sequences optimized by GEHC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Experimental: Diagnostic mTBI
MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)
干预措施: MRI Diagnostic (Device)
Experimental: Diagnostic Non mTBI
MRI Diagnostic of Non injured subjects that are closely matched to mTBI
干预措施: MRI Diagnostic (Device)
结局指标
主要结局
mTBI Progression Indicated by Clinical Neurological Characteristics, MRI Images, and Quantitative MRI Data From Novel Software
时间窗: Baseline to 3 months
To determine associations between clinical neurological data, MR images, quantitative data from novel software post-processing (sponsor developed software including Volumetry, Kurtosis, Resting State \[RS\], functional magnetic resonance imaging \[fMRI\], and additional post-processing modules may be provided
次要结局
未报告次要终点