Magnetic Resonance Imaging Study on Patients With Trigeminal Neuralgia

Trigeminal Neuralgia Clinical Trial

— MRI-TN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02713646
• Other study ID #: XJTU1AF-CRF-2015-028
• Status: Completed
• Start date: November 28, 2016
• Est. completion date: February 1, 2020

Study information

• Verified date: February 2020
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: February 1, 2020
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Neuralgia
• Trigeminal Neuralgia

Locations

Country	Name	City	State
China	3.0-T MRI scanner (Signa HDxt; GE Medical Systems, WI, USA)	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

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 — View Citation

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 outco — View Citation

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):60 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Sensitivity and Specificity of Detection of Neurovascular Compression by 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.	0 (baseline)
Secondary	Sensitivity and Specificity of Detection of Neurovascular Compression by CPR Compared with Surgical Findings	Severity of neurovascular compression, which will be judged by CPR, is the same criterion as that in the Outcome 3, and the results of CPR need to be compared with the intraoperative findings to obtain the sensitivity and specificity, respectively.	0 (baseline)
Secondary	Sensitivity and Specificity of Detection of Neurovascular Compression by MRVE Compared with Surgical Findings	Severity of neurovascular compression, which will be judged by MRVE, is the same criterion as that in the Outcome 3, and the results of MRVE need to be compared with the intraoperative findings to obtain the sensitivity and specificity, respectively.	0 (baseline)
Secondary	Change from Baseline Visual Analog Score (VAS) for Pain at 12 months	Baseline VAS will be evaluated by Visual Analog Scale for Pain prior to the operations. Graphic formats for the VAS can be obtained online: http:// www.amda.com/tools/library/whitepapers/hospiceinltc/appendix-a.pdf. Meanwhile, the study endpoint is 12 months after the operation, which need another measurement of VAS.	0, 12 months