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NCT Number: NCT02713646

Magnetic Resonance Imaging Study on Patients With Trigeminal Neuralgia

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.

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Key information

Conditions

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

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Xi'an, Shaanxi, 710061, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Change from Baseline V (mm3) at 12 months

    Time frame: 0, 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.

  2. Change from Baseline CSA (mm2) at 12 months

    Time frame: 0, 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.

Secondary outcomes

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

    Time frame: 0 (baseline)

    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.

  2. Sensitivity and Specificity of Detection of Neurovascular Compression by CPR Compared with Surgical Findings

    Time frame: 0 (baseline)

    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.

  3. Sensitivity and Specificity of Detection of Neurovascular Compression by MRVE Compared with Surgical Findings

    Time frame: 0 (baseline)

    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.

  4. Change from Baseline Visual Analog Score (VAS) for Pain at 12 months

    Time frame: 0, 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.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Registry information

Official study title

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

Acronym: MRI-TN

Important dates

Study start
2016
Primary completion
2018
Study completion
2020
First posted
Mar 21, 2016
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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