Magnetic Resonance Imaging Study on Patients With Hemifacial Spasm

NCT04645277 | Recruiting DMC

• 1 other identifier: XJTU1AF-CRF-2020-017
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hemifacial Spasm; Magnetic Resonance Imaging

Keywords

Curved Planar Reconstruction; Magnetic Resonance Virtual Endoscopy

Outcome Measures

Primary Outcomes (3)

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

  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.

  2021.1-2023.1

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

  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.

  2021.1-2023.1

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

  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.

  2021.1-2023.1

Secondary Outcomes (2)

• Change of Facial Nerve Volume (V) from Baseline to 3 years later

  2021.1-2024.1

• Change of Facial Nerve Cross Sectional Area (CSA) from Baseline to 3 years later

  2021.1-2024.1

Study Arms (2)

Patients with MRI using two dimensional reconstruction

Device: Scanning with magnetic resonance imaging

Patients with MRI using three dimensional reconstruction

Device: Scanning with magnetic resonance imaging

Interventions

Scanning with magnetic resonance imaging DEVICE

Facial nerves and adjacent blood vessels are scanned using MRI in the patients with hemifacial spasm (HFS). Then multiplanar reconstruction (two dimensional), along with curved planar reconstruction and magnetic resonance virtual endoscopy (three dimensional), will be performed in the different groups of HFS.

Patients with MRI using three dimensional reconstruction; Patients with MRI using two dimensional reconstruction

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Primary hemifacial spasm patients, the typical symptoms are unilateral, involuntary, and intermittent contractions of facial muscles innervated by the ipsilateral facial nerve.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Related Publications (4)

• Haller S, Etienne L, Kovari E, Varoquaux AD, Urbach H, Becker M. Imaging of Neurovascular Compression Syndromes: Trigeminal Neuralgia, Hemifacial Spasm, Vestibular Paroxysmia, and Glossopharyngeal Neuralgia. AJNR Am J Neuroradiol. 2016 Aug;37(8):1384-92. doi: 10.3174/ajnr.A4683. Epub 2016 Feb 18.

  PMID: 26892985 RESULT

• Zhang P, Selim MH, Wang H, Kuang W, Wu M, Ji C, Hu G, Wu L, Zhu X, Guo H. Intraoperative Measuring of the Offending Vessel's Pressure on the Facial Nerve at Root Exit Zone in Patients with Hemifacial Spasm During Microvascular Decompression: A Prospective Study. World Neurosurg. 2019 Feb;122:e89-e95. doi: 10.1016/j.wneu.2018.09.080. Epub 2018 Sep 25.

  PMID: 30261393 RESULT

• Naraghi R, Tanrikulu L, Troescher-Weber R, Bischoff B, Hecht M, Buchfelder M, Hastreiter P. Classification of neurovascular compression in typical hemifacial spasm: three-dimensional visualization of the facial and the vestibulocochlear nerves. J Neurosurg. 2007 Dec;107(6):1154-63. doi: 10.3171/JNS-07/12/1154.

  PMID: 18077953 RESULT

• Takao T, Oishi M, Fukuda M, Ishida G, Sato M, Fujii Y. Three-dimensional visualization of neurovascular compression: presurgical use of virtual endoscopy created from magnetic resonance imaging. Neurosurgery. 2008 Jul;63(1 Suppl 1):ONS139-45; discussion ONS145-6. doi: 10.1227/01.neu.0000335028.77779.7c.

  PMID: 18728591 RESULT

MeSH Terms

Conditions

Hemifacial Spasm

Interventions

Radionuclide Imaging; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Spasm; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Radioisotope; Tomography

Study Officials

• Ming Zhang, M.D. & Ph.D.

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuan Wang, M.D.

CONTACT

0086-13324598144; wangyuan8003@126.com

Chenguang Guo, M.D.

CONTACT

0086-15591877956; xiaoguo79@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2020
• First Posted: November 27, 2020
• Study Start: January 1, 2021
• Primary Completion: June 30, 2024
• Study Completion: December 30, 2024
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)