Assessment in Patients With Essential Trigeminal Neuralgia of Nerve Involvement by MRI in DTI and Functional Connectivity in "Resting State" (SENSE)

Essential trigeminal neuralgia is the most common facial pain. In forms resistant to drug and disabling treatments, surgical treatment may be offered to the patient. The type of intervention will be conditioned by the presence or absence of a vasculo-nervous conflict objectified by MRI(Magnetic resonance imaging) Morphological MRI with contrast injection does not always allow an accurate assessment of trigeminal nerve damage in patients with essential facial neuralgia. Despite advances in the anatomical definition of high-resolution MRI, the correlation between a vascular conflict visible on MRI and present during surgery and prolonged postoperative clinical improvement remains insufficient These data raise the question of additional imaging sequences to assess the distressing characteristics of NT in addition to the usual anatomical criteria for compression By performing during morphological MRI two additional sequences, one in diffusion tensor (DTI) and one in resting state (fMRI), we could better characterize the achievement of NT

The contribution of new imaging sequences in the context of essential trigeminal neuralgia treated with microvascular decompression (MVD) would:

1/improve the diagnostic criteria for suffering and compression of the NT (trigeminal nerve) 2 / define objective prognostic criteria for the effectiveness of surgery, particularly in the context of unusual clinical symptoms or moderate conflict on MRI (Magnetic resonance imaging) 3 / to analyze more precisely the causes of recurrence at a distance from surgery and help in the decision of re-intervention Our main hypothesis: the addition of a diffusion tensor sequence and sequences (allowing functional brain analysis) in addition to standard anatomical MRI in the assessment of a vasculo-nervous conflict would allow us to better characterize involvement of the trigeminal nerve in essential facial neuralgia. It also helps guide therapeutic management and surgical indications.

This is a prospective, monocentric cohort study. It will be offered to patients referred to neurosurgery or to the pain assessment and treatment center for assessment and management of a neuralgia of the essential trijumeau unilateral.

Study Overview

• Status: Recruiting
• Conditions: Trigeminal Neuralgia; Microvascular Decompression Surgery; Diffusion Tensor Imaging
• Intervention / Treatment: Procedure: Assessment of the trigeminal nerve by diffusion tensor MRI and in "resting state" in the context of essential neuralgia

Detailed Description

Name:

MRI in morphological sequence, diffusion tensor and resting functional

Description:

The MR exam will be performed on the Neuroradiology 3 Tesla (Philips) MR according to the following protocol:

• Standard anatomical sequences T1, FLAIR, TOF, DRIVE, sequence centered on the V after injection of gadolinated contrast product as part of standard care
• Diffusion tensor sequence (DTI) It allows the analysis of encephalic white matter beams in healthy subjects as well as in many pathologies
• resting state sequence (fMRI) This sequence is based on the spontaneous correlation of the BOLD signal (blood-oxygen level dependent) between different distant brain regions.
• The total duration of the exam will be about 45 minutes, including 15 minutes for the sequences added by the search.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75019
    • Recruiting
    • Fondation Ophtalmologique de Rothschild
    • Contact: Caroline Le Guerinel; Phone Number: +33148036911; Email: cleguerinel@for.paris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients (18 years and over);
• Supported in the neurosurgery department or at the assessment and treatment center for pain for unilateral essential trigeminal neuralgia with search for vasculo-nervous conflict;

Exclusion Criteria:

• Patient with neurodegenerative or inflammatory neurological pathology;
• Patient who has already been operated on for a DMV;
• Absolute contraindication to MRI
• Patient benefiting from a legal protection measure; with impaired judgment skills or unable to receive information;
• Pregnant or breastfeeding women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: MRI in morphological sequence, diffusion tensor and resting functional; standard anatomical sequences T1, FLAIR (Fluid Attenuated Inversion Recovery), TOF(Time-of-flight MR angiography) , DRIVE, sequence centered on the V after injection of gadolinated contrast product as part of routine care,; diffusion tensor sequence (DTI)	Procedure: Assessment of the trigeminal nerve by diffusion tensor MRI and in "resting state" in the context of essential neuralgia; Assessment of the trigeminal nerve by diffusion tensor MRI and in "resting state" in the context of essential neuralgia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of micro-structural changes in the trigeminal nerve in essential neuralgia	Describe in patients with unilateral essential trigeminal neuralgia, the micro-structural modifications of the trigeminal nerve observed from data from the DTI sequence compared to the healthy contralateral side	Day 0 - inclusion

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2022
• Primary Completion (Estimated): September 15, 2024
• Study Completion (Estimated): September 15, 2024

Study Registration Dates

• First Submitted: September 9, 2021
• First Submitted That Met QC Criteria: September 20, 2021
• First Posted (Actual): September 21, 2021

Study Record Updates

• Last Update Posted (Estimated): December 13, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Resting state
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Stomatognathic Diseases; Mouth Diseases; Peripheral Nervous System Diseases; Cranial Nerve Diseases; Facial Nerve Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Neuralgia; Trigeminal Neuralgia
• Other Study ID Numbers: CLL_2020_37

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No