Ignite Creation Date:
2024-05-06 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05051072
Status:
RECRUITING
Last Update Posted:
2023-12-13
First Post:
2021-09-09
Brief Title:
Assessment in Patients With Essential Trigeminal Neuralgia of Nerve Involvement by MRI in DTI and Functional Connectivity in Resting State
Sponsor:
Fondation Ophtalmologique Adolphe de Rothschild
Organization:
Fondation Ophtalmologique Adolphe de Rothschild
Study Overview
Official Title:
Assessment in Patients With Essential Trigeminal Neuralgia of Nerve Involvement by MRI in DTI and Functional Connectivity in Resting State
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SENSE
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 MRIMagnetic 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
1improve 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
The contribution of new imaging sequences in the context of essential trigeminal neuralgia treated with microvascular decompression MVD would
1improve 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None