Clinical trial NCT04645277: Magnetic Resonance Imaging Study on Patients With Hemifacial Spasm
Official title: Clinical Research on Patients With Hemifacial Spasm by Multi-planar Reconstruction, Curved Planar Reconstruction and Magnetic Resonance Virtual Endoscopy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hemifacial Spasm
Magnetic Resonance Imaging
Keywords: Curved Planar Reconstruction
Magnetic Resonance Virtual Endoscopy
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2020-11-27
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Sensitivity and Specificity of Detection of Neurovascular Compression by Multiplanar Reconstruction (MPR) Compared with Surgical Findings
timeFrame: 2021.1-2023.1
measure: Sensitivity and Specificity of Detection of Neurovascular Compression by Curved Planar Reconstruction (CPR) Compared with Surgical Findings
timeFrame: 2021.1-2023.1
measure: Sensitivity and Specificity of Detection of Neurovascular Compression by Magnetic Resonance Virtual Endoscopy (MRVE) Compared with Surgical Findings
timeFrame: 2021.1-2023.1
Secondary outcomes:
measure: Change of Facial Nerve Volume (V) from Baseline to 3 years later
timeFrame: 2021.1-2024.1
measure: Change of Facial Nerve Cross Sectional Area (CSA) from Baseline to 3 years later
timeFrame: 2021.1-2024.1
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Ming Zhang, M.D. & Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.