Clinical trial NCT02713646: Magnetic Resonance Imaging Study on Patients With Trigeminal Neuralgia
Official title: Applied Research on Patients With Trigeminal Neuralgia by Multi-planar Reconstruction, Curved Planar Reconstruction and Magnetic Resonance Virtual Endoscopy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trigeminal Neuralgia
Keywords: MRI
Virtual Endoscopy
Pain Measurement
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2016-03-21
Enrollment: 55
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Chronic trigeminal neuralgia patients prior to the surgery of microvascular decompression (MVD) or Gamma Knife radiofrequency ablation (GKRFA)

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline V (mm3) at 12 months
timeFrame: 0, 12 months
measure: Change from Baseline CSA (mm2) at 12 months
timeFrame: 0, 12 months
Secondary outcomes:
measure: Sensitivity and Specificity of Detection of Neurovascular Compression by MPR Compared with Surgical Findings
timeFrame: 0 (baseline)
measure: Sensitivity and Specificity of Detection of Neurovascular Compression by CPR Compared with Surgical Findings
timeFrame: 0 (baseline)
measure: Sensitivity and Specificity of Detection of Neurovascular Compression by MRVE Compared with Surgical Findings
timeFrame: 0 (baseline)
measure: Change from Baseline Visual Analog Score (VAS) for Pain at 12 months
timeFrame: 0, 12 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: 3.0-T MRI scanner (Signa HDxt; GE Medical Systems, WI, USA)
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Ming Zhang, M.D. & Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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 outcomes. J Neurosurg. 2014 Jun;120(6):1484-95. doi: 10.3171/2014.2.JNS131288. Epub 2014 Apr 18.
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.
citation: 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.
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):603-7. doi: 10.3174/ajnr.A1409. Epub 2008 Nov 27.
citation: 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.