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Trigeminal NeuralgiaMRI-TNNCT02713646

Magnetic Resonance Imaging Study on Patients With Trigeminal Neuralgia

An observational study of Trigeminal Neuralgia, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 35 to 70 years
Conditions the study is for
Trigeminal Neuralgia
How many people
55 participants
Where
1 siteChina
Study dates
28 Nov 2016to 1 Feb 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

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

    Xi'an, Shaanxi, 710061

Other trials in China

About this study

Official title: 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.

Keywords
MRI, Virtual Endoscopy, Pain Measurement
Medical subject headings
Trigeminal Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02713646
Study groupRoleWhat they receive
patients with primary trigeminal neuralgiaNot described
healthy subjectsNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 0, 12 months

  2. 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.

    Measured: 0, 12 months

Secondary outcomes (4)

  1. 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.

    Measured: 0 (baseline)

  2. 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.

    Measured: 0 (baseline)

  3. 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.

    Measured: 0 (baseline)

  4. 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.

    Measured: 0, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2016 (estimated)
  2. Study start28 Nov 2016
  3. Primary completion31 Dec 2018
  4. Study completion1 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02713646
Sponsor's protocol ID
XJTU1AF-CRF-2015-028
Acronym
MRI-TN
Status last verified
Feb 2020
First submitted
6 Mar 2016
Last updated
16 Feb 2023
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Publications

  • 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.

    PubMed 24745706

  • 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.

    PubMed 16436823

  • 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.

    PubMed 20227216

  • 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.

    PubMed 19039051

  • 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.

    PubMed 40663271

  • 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.

    PubMed 38001310

  • 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.

    PubMed 30086682

Questions about this trial

What is this clinical trial studying?

An observational study of Trigeminal Neuralgia, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline V (mm3) at 12 months (time frame: 0, 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02713646, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.

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