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NCT Number: NCT05051072

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondation Ophtalmologique de Rothschild

Paris, 75019, France

Location status: Recruiting

Location contact

Caroline Le Guerinel

CONTACT

[email protected]

+33148036911

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Assessment of micro-structural changes in the trigeminal nerve in essential neuralgia

    Time frame: Day 0 - inclusion

    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

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Acronym: SENSE

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Sep 21, 2021
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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