跳至主要内容
临床试验/NCT02713646
NCT02713646已完成不适用

Applied Research on Patients With Trigeminal Neuralgia by Multi-planar Reconstruction, Curved Planar Reconstruction and Magnetic Resonance Virtual Endoscopy

First Affiliated Hospital Xi'an Jiaotong University1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2016年11月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
1
主要终点
Change from Baseline CSA (mm2) at 12 months

研究概览

简要总结

Up to now, multiplanar reconstruction (MPR) has been widely used to detect the neurovascular compressions (NVC) on the patients with idiopathic trigeminal neuralgia (ITN). However, due to lack of stereoscopic vision, this traditional method sometimes cannot meet the requirement on identifying the existence and details of NVC, especially when the aberrant vessels turn out to be delicate veins. The three-dimensional analytic techniques, such as curved planar reconstruction (CPR) and magnetic resonance virtual endoscopy (MRVE), may be helpful to improve the sensitivity and specificity on the demonstration of NVC with stereo and dynamic views, so as to assist to design the surgical plan.

Furthermore, the frequent finding of NVC on MRI studies of asymptomatic patients incited the creation of several strict criteria for the imaging diagnosis of NVC: the vessel must cross perpendicular to the long axis of the nerve, the nerve must be deviated or indented at the root entry zoon (REZ) by the vessel. Alternatively, morphological measurement of the nerve may correlate with the severity of facial pain due to atrophy of the nerve in most cases of ITN, and is likely secondary to the micro-structural abnormalities, such as axonal loss, demyelination, collagen deposition, etc. In this study, cross-sectional area (CSA) and volume (V) of the cisternal trigeminal nerve will be assessed to determine whether it can be a useful biomarker for predicting the degree of ITN.

研究设计

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

入排标准

年龄范围
35 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis according to the International Classification of Headache Disorders criteria (3rd edition); 1 year disease duration at least.

排除标准

  • Secondary causes of ITN; Precarious general health status; Percutaneous lesions or surgical treatments; Cardiac pacemaker or metal implants.

结局指标

主要结局

Change from Baseline CSA (mm2) at 12 months

时间窗: 0, 12 months

Baseline CSA (mm2) refers to the cross sectional area of the cisternal trigeminal nerve prior to the surgical treatment. Meanwhile, the study endpoint is 12 months after the operation, which need another measurement of CSA. The CSA is calculated at 5 mm from the entry of the trigeminal nerve into the pons in an image plane perfectly perpendicular to the course of each nerve, which also need using a mouse-driven cursor in MIPAV software.

Change from Baseline V (mm3) at 12 months

时间窗: 0, 12 months

Baseline V (mm3) refers to the volume of the cisternal trigeminal nerve prior to the surgical treatment. Meanwhile, the study endpoint is 12 months after the operation, which need another measurement of V. Measurements of V will be performed using Medical Image Processing, Analysis, and Visualization software (MIPAV, http://mipav.cit.nih.gov/). The measurements start from the point where the nerves enter the pons to an imaginary demarcation made at the entrance of the nerves into Meckel's cave. The trigeminal nerves are manually delineated in each traverse section. The V will be automatically calculated with the MIPAV software.

次要结局

  • Sensitivity and Specificity of Detection of Neurovascular Compression by CPR Compared with Surgical Findings(0 (baseline))
  • Sensitivity and Specificity of Detection of Neurovascular Compression by MRVE Compared with Surgical Findings(0 (baseline))
  • Change from Baseline Visual Analog Score (VAS) for Pain at 12 months(0, 12 months)
  • Sensitivity and Specificity of Detection of Neurovascular Compression by MPR Compared with Surgical Findings(0 (baseline))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验