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Recruiting Not applicable

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

NCT05051072 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2022-04-27
Last updated
2025-06-11

Condition(s) studied

Trigeminal NeuralgiaMicrovascular Decompression SurgeryDiffusion Tensor Imaging

Investigational drug(s) / intervention(s)

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Assessment of micro-structural changes in the trigeminal nerve in essential neuralgia — 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

Trial sites (1)

FacilityCityRegionStatus
Fondation Ophtalmologique de Rothschild Paris France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05051072 on ClinicalTrials.gov ↗ ← All trials in France