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临床试验/NCT06094166
NCT06094166招募中不适用

Quantitative Magnetic Resonance Imaging Parameters as Predictors of Outcome for Non-Myelopathic Degenerative Cervical Cord Compression: A Longitudinal Study

Masaryk University1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
160
试验地点
1
主要终点
dMRI: signs of microstructural myelopathy

研究概览

简要总结

Quantitative Magnetic Resonance Imaging Parameters as Predictors of Outcome for Non-Myelopathic Degenerative Cervical Cord Compression: A Longitudinal Study

详细描述

The study uses semi-automated detection of anatomical metrics (morphometric parameters) and DCC with Spinal Cord Toolbox (SCT). This method have been proven more reliable than expert's manual rating, the introduction of the automated method will be utilized in the future multi-centre and longitudinal studies. Routine anatomical morphometric parameters such as compressive ratio (CR) and cross-sectional area (CSA) will be acquired along with microstructural and metabolic metrics obtained with validated dMRI and MRS methods, remote cervical cord atrophy from voxel-based MRI volumetry, T2* white matter/gray matter (WM/GM) signal-intensity ratio, and also metrics obtained with novel Intravoxel Incoherent Motion (IVIM) method will predict progression of NMDCC into symptomatic DCM. "Natural course" (i.e., speed of progression) of the severity of DCC assessed with anatomical and advanced MRI/MRS metrics is not known but may play a role in the progression from NMDCC to symptomatic DCM. Aims of this project are: To determine independent predictors of unfavourable outcome - progression into symptomatic degenerative cervical myelopathy (DCM) - among quantitative MRI parameters and compare them with already defined clinical and electrophysiological predictors. To evaluate the "natural course" of MRI descriptors of compression and its severity, and the correlation between progression and development of symptomatic DCM. To implement automated detection of cervical cord compression using Spinal Cord Toolbox based on automatically computed morphometric parameters.

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

  • Subject with no contraindication to MR examination. Clinically asymptomatic cervical spinal cord compression or subjects with no spinal cord compression.

排除标准

  • A subject will be excluded if he/she has a contraindication to MR scanning implanted metal clips or wires of the type which may concentrate radiofrequency fields or cause tissue damage from twisting in a magnetic field.
  • Pregnancy
  • Claustrophobia

结局指标

主要结局

dMRI: signs of microstructural myelopathy

时间窗: 45 minutes

fractional anisotropy

MRS: signs of metabolic myelopathy (above the level of compression)

时间窗: 45 minutes

Myo-ins/NAA ratio

Anatomical MRI metrics

时间窗: 45 minutes

cross-sectional area (CSA)

Voxel-based MRI volumetry (remote spinal cord atrophy above the compression level)

时间窗: 45 minutes

remote cervical cord atrophy

次要结局

  • IVIM and T2*WM/GM signal-intensity ratio(45 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tomáš Horák

prof. MUDr. Josef Bednarik, CSc., FCMA, FEAN

Masaryk University

研究点 (1)

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