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

Trigeminal Neuralgia Clinical Trial

— SENSE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05051072
• Other study ID #: CLL_2020_37
• Status: Recruiting
• Phase: N/A
• Start date: April 27, 2022
• Est. completion date: September 15, 2024

Study information

• Verified date: December 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 15, 2024
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diffusion Tensor Imaging
• Microvascular Decompression Surgery
• Neuralgia
• Trigeminal Neuralgia

Intervention

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

Locations

Country	Name	City	State
France	Fondation Ophtalmologique de Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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