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临床试验/NCT04645277
NCT04645277招募中不适用

Clinical Research on Patients With Hemifacial Spasm 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 60 人开始时间: 2021年1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
60
试验地点
1
主要终点
Sensitivity and Specificity of Detection of Neurovascular Compression by Multiplanar Reconstruction (MPR) Compared with Surgical Findings

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 hemifacial spasm (HFS). However, due to lack of stereoscopic vision, this traditional method sometimes can not meet the requirement on identifying the details of NVC, especially when the aberrant vessels turn out to be veins not arteries. 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 the design of 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 spasm due to atrophy of the nerve in most cases of HFS, 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 facial nerve will be assessed to determine whether it can be a useful biomarker for predicting the degree of HFS.

研究设计

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

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Primary HFS patients according to medical history and typical facial muscle spasms that are unilateral, involuntary, and had intermittent contractions innervated by the ipsilateral facial nerve. The patient has 1 year disease duration at least.

排除标准

  • Secondary causes of HFS, such as tumors or cysts compressing the facial nerve in the cerebellar pontine cistern; Precarious general health status; Percutaneous lesions or surgical treatments; Cardiac pacemaker or metal implants.

结局指标

主要结局

Sensitivity and Specificity of Detection of Neurovascular Compression by Multiplanar Reconstruction (MPR) Compared with Surgical Findings

时间窗: 2021.1-2023.1

Severity of neurovascular compression, which will be judged by MPR, is defined as follows: 1 = no compression; 2 = contact by a vessel; 3 = indentation by a vessel; and 4 = nerve displacement or distortion by a vessel, and the results of MPR need to be compared with the intraoperative findings to obtain the sensitivity and specificity, respectively.

Sensitivity and Specificity of Detection of Neurovascular Compression by Curved Planar Reconstruction (CPR) Compared with Surgical Findings

时间窗: 2021.1-2023.1

Severity of neurovascular compression, which will be judged by CPR, is the same criterion as that in the Outcome 1, and the results of CPR need to be compared with the intraoperative findings to obtain the sensitivity and specificity, respectively.

Sensitivity and Specificity of Detection of Neurovascular Compression by Magnetic Resonance Virtual Endoscopy (MRVE) Compared with Surgical Findings

时间窗: 2021.1-2023.1

Severity of neurovascular compression, which will be judged by MRVE, is the same criterion as that in the Outcome 1, and the results of MRVE need to be compared with the intraoperative findings to obtain the sensitivity and specificity, respectively.

次要结局

  • Change of Facial Nerve Cross Sectional Area (CSA) from Baseline to 3 years later(2021.1-2024.1)
  • Change of Facial Nerve Volume (V) from Baseline to 3 years later(2021.1-2024.1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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