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

NCT05051072 | Recruiting DMC

• 1 other identifier: CLL_2020_37
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Trigeminal Neuralgia; Microvascular Decompression Surgery; Diffusion Tensor Imaging

Keywords

Resting state

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

MRI in morphological sequence, diffusion tensor and resting functional

OTHER

* 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

Interventions

Assessment of the trigeminal nerve by diffusion tensor MRI and in "resting state" in the context of essential neuralgia PROCEDURE

Assessment of the trigeminal nerve by diffusion tensor MRI and in "resting state" in the context of essential neuralgia

MRI in morphological sequence, diffusion tensor and resting functional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation Ophtalmologique de Rothschild

Paris, 75019, France

RECRUITING

MeSH Terms

Conditions

Trigeminal Neuralgia

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 21, 2021
• Study Start: April 27, 2022
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)