Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 477
- 试验地点
- 13
- 主要终点
- Neuropsychological Assessments
研究概览
简要总结
This is an open-label, non-randomized, prospective, multi-site, parallel group (segment), hypothesis-generating study designed to collect data that will aid in future scientific and engineering exploration of correlations between clinical neuropsychological assessments and GE Research Pack II advanced MR imaging in mTBI patients. The results are primarily intended for scientific inquiry and engineering development purposes, and may be used in future regulatory submissions.
详细描述
This data-driven study is being conducted for hypothesis generation in population of mild traumatic brain injury (mTBI) patients using advanced applications for magnetic resonance imaging (MRI) developed by the Sponsor, GE Healthcare (GEHC), and corresponding clinical neuropsychological assessments. This data is intended for future use in development of specialized MR acquisition, reconstruction, and processing software intended to identify mTBI biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- 是
入选标准
- •Subjects included as mTBI patients (Segment 1) will:
- •Be aged ≥15 and ≤50 years old at the time of enrollment;
- •Be diagnosed with mTBI according to the standard diagnostic procedures at the investigational site in a timeframe that meets enrollment criteria for enrollment within 72 hours (Visit 1) or 7±2 days (Visit 3) from injury.
- •Be capable of sufficiently clear communication and language fluency to allow the subject to provide written informed consent, or assent with parental or guardian consent for minors, and to complete study assessments (as per Section 6.3 - Protection of Vulnerable Subjects) for participation in all parts of the study.
- •Subjects included as non-mTBI controls (Segment 2) will:
- •Be aged ≥15 and ≤50 years old at the time of enrollment;
- •Are of similar characteristics as the mTBI population in terms of gender, age, handedness, educational level, and scanner criteria (as per Section 6.1.1 Enrollment of non-mTBI controls)
- •Be capable of sufficiently clear communication and language fluency to allow the subject to provide written informed consent, or assent with parental or guardian consent for minors, and to complete study assessments (as per Section 6.3 - Protection of Vulnerable Subjects), for participation in all parts of the study.
排除标准
- •Subjects will be excluded that have: mTBI
- •Loss of consciousness (LOC) ≥5 minutes;
- •Posttraumatic amnesia lasting ≥24 hr following mTBI;
- •Current or prior (within past 10 years) moderate to severe TBI
- •Diagnosis of mTBI within the past 6 months;
- •Epilepsy with recurring seizures in past 10 years;
- •Drug abuse (except marijuana) in past 10 years based on DAST-10 screening;
- •Alcohol abuse based on AUDIT-C screening;
- •Current primary Axis I or II psychiatric disorders, except for disorders classified as minor and not expected to impact study conduct or integrity (as detailed in Appendix C - Screening Axis I/II Disorders):
- •History of brain mass, neurosurgery, stroke, white matter disease, and/or dementia;
- •Known cognitive dysfunction or structural brain disease/malformation;
- •Structural brain injury on prior neuroimaging findings;
- •Been prescribed antipsychotic/antiepileptic medications;
- •Unable (such as due to urgent medical care needs) or unwilling to complete study procedures accurately or have any conflict of interest that could affect study results, in the opinion of the investigator;
- •Contraindications to MRI scanning, including:
- •Current or suspected pregnancy, per site practice;
- •Other conditions that may constitute a hazard to the subject during study participation, per investigator;
- •Inability to comply with any part of the site's MR safety policy.
- •Subjects will be excluded that have:- non-TBI (controls)
- •Diagnosis of mTBI within the past 6 months;
- •Prior (within past 10 years) moderate to severe TBI (GCS <13);
- •Epilepsy with recurring seizures in past 10 years;
- •Drug abuse (except marijuana) in past 10 years based on DAST-10 screening;
- •Alcohol abuse based on AUDIT-C screening;
- •Current primary Axis I or II psychiatric disorders, except for disorders classified as minor and not expected to impact study conduct or integrity (as detailed in Appendix C - Screening Axis I/II Disorders):
- •History of brain mass, neurosurgery, stroke, white matter disease, and/or dementia;
- •Known cognitive dysfunction or structural brain disease/malformation;
- •Structural brain injury on prior neuroimaging findings;
- •Been prescribed antipsychotic/antiepileptic medications;
- •Unable (such as due to urgent medical care needs) or unwilling to complete study procedures accurately or have any conflict of interest that could affect study results, in the opinion of the investigator;
研究组 & 干预措施
mTBI patient group (Segment 1)
1.5T or 3.0T MRI brain scanning with research sequences at 3 to 4 intervals in the acute period, with psychological cognitive evaluations at each MR visit
Patients in the acute period following recent diagnosis of mild traumatic brain injury (mTBI)
干预措施: MRI (Procedure)
non-TBI patients (Segment 2)
Control subjects with no recent mild traumatic brain injury. 1.5T or 3.0T MRI brain scanning with research sequences at 3 to 4 intervals in the acute period, with psychological cognitive evaluations at each MR visit
干预措施: MRI (Procedure)
结局指标
主要结局
Neuropsychological Assessments
时间窗: Per patient scanning over 3 months
Neuropsychological assessments collected from subjects who completed the study.
MRI Image Data Sets
时间窗: Per patient scanning over 3 months
MRI image data sets collected from subjects who completed the study.
次要结局
未报告次要终点