Assessment in Patients With Essential Trigeminal Neuralgia of Nerve Involvement by MRI in DTI and Functional Connectivity in "Resting State" (SENSE)
Primary Purpose
Trigeminal Neuralgia, Microvascular Decompression Surgery, Diffusion Tensor Imaging
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Assessment of the trigeminal nerve by diffusion tensor MRI and in "resting state" in the context of essential neuralgia
Sponsored by
About this trial
This is an interventional other trial for Trigeminal Neuralgia focused on measuring Resting state
Eligibility Criteria
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
Sites / Locations
- Fondation Ophtalmologique de RothschildRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
MRI in morphological sequence, diffusion tensor and resting functional
Arm Description
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)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05051072
First Posted
September 9, 2021
Last Updated
August 10, 2022
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
1. Study Identification
Unique Protocol Identification Number
NCT05051072
Brief Title
Assessment in Patients With Essential Trigeminal Neuralgia of Nerve Involvement by MRI in DTI and Functional Connectivity in "Resting State"
Acronym
SENSE
Official Title
Assessment in Patients With Essential Trigeminal Neuralgia of Nerve Involvement by MRI in DTI and Functional Connectivity in "Resting State"
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2022 (Actual)
Primary Completion Date
September 15, 2024 (Anticipated)
Study Completion Date
September 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trigeminal Neuralgia, Microvascular Decompression Surgery, Diffusion Tensor Imaging
Keywords
Resting state
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MRI in morphological sequence, diffusion tensor and resting functional
Arm Type
Other
Arm Description
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)
Intervention Type
Procedure
Intervention Name(s)
Assessment of the trigeminal nerve by diffusion tensor MRI and in "resting state" in the context of essential neuralgia
Intervention Description
Assessment of the trigeminal nerve by diffusion tensor MRI and in "resting state" in the context of essential neuralgia
Primary Outcome Measure Information:
Title
Assessment of micro-structural changes in the trigeminal nerve in essential neuralgia
Description
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
Time Frame
Day 0 - inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Fondation Ophtalmologique de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Le Guerinel
Phone
+33148036911
Email
cleguerinel@for.paris
12. IPD Sharing Statement
Learn more about this trial
Assessment in Patients With Essential Trigeminal Neuralgia of Nerve Involvement by MRI in DTI and Functional Connectivity in "Resting State"
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