Magnetic Resonance Imaging Study on Patients With Trigeminal Neuralgia (MRI-TN)

February 14, 2023 updated by: First Affiliated Hospital Xi'an Jiaotong University

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • 3.0-T MRI scanner (Signa HDxt; GE Medical Systems, WI, USA)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
healthy subjects
patients with primary trigeminal neuralgia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0, 12 months
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.
0, 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0 (baseline)
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.
0 (baseline)
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.
0 (baseline)
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.
0, 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2016

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

February 1, 2020

Study Registration Dates

First Submitted

March 6, 2016

First Submitted That Met QC Criteria

March 15, 2016

First Posted (Estimate)

March 21, 2016

Study Record Updates

Last Update Posted (Actual)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 14, 2023

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF-CRF-2015-028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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