Magnetic Resonance Imaging Study on Patients With Trigeminal Neuralgia

NCT02713646 | Completed DMC

• 1 other identifier: XJTU1AF-CRF-2015-028
• Study Type: observational
• Target: 55
• 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 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.

Conditions

Trigeminal Neuralgia

Keywords

MRI; Virtual Endoscopy; Pain Measurement

Outcome Measures

Primary Outcomes (2)

• Change from Baseline V (mm3) at 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.

  0, 12 months

• Change from Baseline CSA (mm2) at 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.

  0, 12 months

Secondary Outcomes (4)

• Sensitivity and Specificity of Detection of Neurovascular Compression by MPR Compared with Surgical Findings

  0 (baseline)

• 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

Study Arms (2)

patients with primary trigeminal neuralgia

healthy subjects

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Chronic trigeminal neuralgia patients prior to the surgery of microvascular decompression (MVD) or Gamma Knife radiofrequency ablation (GKRFA)

You may qualify if:

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

You may not qualify if:

• Secondary causes of ITN; 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)

3.0-T MRI scanner (Signa HDxt; GE Medical Systems, WI, USA)

Xi'an, Shaanxi, 710061, China

Location

Related Publications (7)

• Leal PR, Barbier C, Hermier M, Souza MA, Cristino-Filho G, Sindou M. Atrophic changes in the trigeminal nerves of patients with trigeminal neuralgia due to neurovascular compression and their association with the severity of compression and clinical outcomes. J Neurosurg. 2014 Jun;120(6):1484-95. doi: 10.3171/2014.2.JNS131288. Epub 2014 Apr 18.

  PMID: 24745706 RESULT

• Erbay SH, Bhadelia RA, O'Callaghan M, Gupta P, Riesenburger R, Krackov W, Polak JF. Nerve atrophy in severe trigeminal neuralgia: noninvasive confirmation at MR imaging--initial experience. Radiology. 2006 Feb;238(2):689-92. doi: 10.1148/radiol.2382042214.

  PMID: 16436823 RESULT

• Borges A, Casselman J. Imaging the trigeminal nerve. Eur J Radiol. 2010 May;74(2):323-40. doi: 10.1016/j.ejrad.2010.02.006. Epub 2010 Mar 12.

  PMID: 20227216 RESULT

• Satoh T, Omi M, Nabeshima M, Onoda K, Date I. Severity analysis of neurovascular contact in patients with trigeminal neuralgia: assessment with the inner view of the 3D MR cisternogram and angiogram fusion imaging. AJNR Am J Neuroradiol. 2009 Mar;30(3):603-7. doi: 10.3174/ajnr.A1409. Epub 2008 Nov 27.

  PMID: 19039051 RESULT

• Xu H, Jia L, Wang Y, Han W, Li D, Zhang M, Wang Y. Abnormalities of cortical morphology and structural covariance network in the patients with primary trigeminal neuralgia: a preliminary clinical study. Neurol Sci. 2025 Sep;46(9):4527-4535. doi: 10.1007/s10072-025-08360-y. Epub 2025 Jul 15.

  PMID: 40663271 DERIVED

• Xu H, Liu Y, Zeng WT, Fan YX, Wang Y. Distinctive cortical morphological patterns in primary trigeminal neuralgia: a cross-sectional clinical study. Neuroradiology. 2024 Feb;66(2):207-216. doi: 10.1007/s00234-023-03257-z. Epub 2023 Nov 25.

  PMID: 38001310 DERIVED

• Wang Y, Yang Q, Cao D, Seminowicz D, Remeniuk B, Gao L, Zhang M. Correlation between nerve atrophy, brain grey matter volume and pain severity in patients with primary trigeminal neuralgia. Cephalalgia. 2019 Apr;39(4):515-525. doi: 10.1177/0333102418793643. Epub 2018 Aug 7.

  PMID: 30086682 DERIVED

MeSH Terms

Conditions

Trigeminal Neuralgia

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Study Officials

• Ming Zhang, M.D. & Ph.D.

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2016
• First Posted: March 21, 2016
• Study Start: November 28, 2016
• Primary Completion: December 31, 2018
• Study Completion: February 1, 2020
• Last Updated: February 16, 2023

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)