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临床试验/NCT02149511
NCT02149511已完成不适用

Longitudinal Morphometric Changes Following SCI

University of Zurich1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2010年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
94
试验地点
1
主要终点
Cord and brain volume (mm^3) changes

研究概览

简要总结

In patients with chronic spinal cord injury, imaging of the spinal cord and brain above the level of the lesion provides evidence of neural degeneration; however, the spatial and temporal patterns of progression and their relation to clinical outcomes are uncertain. New interventions targeting acute spinal cord injury have entered clinical trials but neuroimaging outcomes as responsive markers of treatment have yet to be established. We aim to use MRI to assess neuronal degeneration above and below the level of the lesion after acute spinal cord injury. In our prospective longitudinal study, we enroll patients with acute traumatic spinal cord injury and healthy controls. We assess patients clinically and by MRI at baseline, 2 months, 6 months, 12 months, and if possible 24 months and 60 months follow-up, and controls by MRI at the same timepoints. We assess cervical atrophy in white and gray matter and use cross-sectional spinal cord area measurements to assess atrophy at cervical level (C2/C3) and in the lumbar enlargement. We use myelinsensitive magnetisation transfer (MT) and longitudinal relaxation rate (R1) maps in the brain to assess microstructural changes associated with myelin. We also use diffusion tensor imaging acquired in the spinal cord at C2/C3 and in the lumbar enlargement to identify axonal loss and demyelination in the spinal white matter. Finally, we assess associations between MRI parameters and clinical improvement.

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

入选标准

  • SCI patients:
  • acute injury to the spinal cord
  • no medical or mental illness
  • written informed consent
  • over the age of 18 years
  • Control subjects:
  • over the age of 18 years
  • written informed consent

排除标准

  • SCI patients:
  • head or brain lesion associated with the trauma leading to the injury
  • epileptic seizures
  • MRI contraindications
  • pregnant women or lactating women
  • Control subjects:
  • pregnant women or lactating women
  • MRI contraindications
  • neurological or psychiatric illness

结局指标

主要结局

Cord and brain volume (mm^3) changes

时间窗: Patients will be recruited within the first months of injury and scanned 6 times during the first 5 years post injury. Healthy controls will follow the same time line.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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