跳至主要内容
临床试验/NCT04955041
NCT04955041Unknown不适用

Effectiveness of T2* MRI in Predicting Prognosis in Patients With Cervical Spondylotic Myelopathy (CSM)

Peking University Third Hospital0 个研究点目标入组 200 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
主要终点
Improvement of neurologic function

研究概览

简要总结

Utilization of T2* MRI in predicting prognosis in patients with cervical spondylotic myelopathy (CSM)

详细描述

Cervical spondylotic myelopathy (CSM), an age-related degenerative disease that is common worldwide, is mainly caused by compression of the spinal cord and may possibly lead to disability. Surgery to reduce direct compression of the spinal cord might alleviate disease progression; due to individual differences, some patients do not benefit from surgery. Prognostic prediction is important because it affects subsequent treatment decision making. Currently, prognosis is generally based on magnetic resonance imaging (MRI) with a detailed macrostructural evaluation of the spinal cord. Unfortunately, the use of conventional MRI indicators (e.g., increased intensity signal [ISI]) to predict CSM outcomes has been controversial because of their subjectivity or the insufficient information contained therein.

A new biomarker, T2* MRI gray matter to white matter signal intensity ratio (GM/WM), is associated with demyelination and gliosis. Previous studies have shown that patients with CSM can have T2* MRI WM / GM changes at the early stage of disease, and the WM / GM value is increased, which is significantly higher than that of normal people, and is related to the spinal cord function score. However, the correlation between this index and long-term prognosis remains to be studied.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • diagnosed with CSM and operated on by one senior orthopedist
  • available preoperative MRI results
  • high-quality image data with no motion artifacts
  • available preoperative and long-term follow-up (≥1 years) mJOA score

排除标准

  • prior head or neck surgery
  • a history of notable additional diseases (spinal cord tumor, multiple sclerosis, syringomyelia, spinal cord injury, or motor neuron disease).

结局指标

主要结局

Improvement of neurologic function

时间窗: at follow-up time (≥1 years)

Postoperative modified Japanese Orthopaedic Association (mJOA) at follow-up time

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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