In Vivo and ex Vivo Validation of MR Tractography of Brain White Matter Tracts - FIBRATLAS II-III
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 134
- 试验地点
- 14
- 主要终点
- Reconstructions of the fiber tracts
研究概览
简要总结
White matter tracts connect cortical areas to other parts of the cortex, to basal ganglia and to the brain stem and spinal cord. These tracts form the internal part of the brain and transmit the nervous impulses. Changes in brain white matter may serve as biomarkers for numerous neurological diseases.
Diffusion Weighted Imaging (DWI) is a non-invasive MRI (Magnetic Resonance Imaging) technique providing information on white matter tracts (tractography) by studying water diffusion. Since it is based on complex mathematical models that only indirectly evaluates the underlying anatomy, tractography need to be validated before being used for research and clinical purposes. Several validation techniques were previously proposed, none of them being fully convincing in human.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 82 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Prior enrollment in a body donation program
- •Age ≥ 82 years
- •Absence of major cognitive impairment as demonstrated by independent living skills in 4 fields evaluated by the IADL (4 items) (Lawton and Brody, 1969)
- •Distance to one of the participating laboratories ≤ 120km
- •Able to remain supine in the MR scanner for acquisition duration (60 min),
- •Affiliation to Social Security
- •Informed and written consent
- •Non Inclusion Criteria:
- •Past or present Neurological or Neurosurgical diseases (excluding trauma or degenerative spinal lesions)
- •Uncontrolled: High blood pressure, diabetes (types I or II), or dyslipemia
- •Contraindications to MRI
- •Contraindication to body donation
- •Exclusion criteria
- •Diagnosis on MRI of brain lesions, excepted common age-related changes
排除标准
- 未提供
结局指标
主要结局
Reconstructions of the fiber tracts
时间窗: 5.5 years
similarity indices, such as modified Haussdorf distance, measured on MRI images
次要结局
- Scores at neuropsychological evaluation(5.5 years)
- Number of subjects included in the database(5.5 years)
- In vivo MRI measures obtained from DWI(5.5 years)