RESting-state Functional MRI for Prediction of Post-surgical Prognosis In Pediatric Drug-Resistant Epilepsy

Recruiting

• Conditions: Epilepsy

• Registration Number: NCT04451278
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief Summary

Resting-state functional MRI (r-fMRI) has emerged in recent years to analyze resting networks. It allows, without active participation of the patients, to identify and analyze the different functional brain networks. The analysis of r-fMRI can be done thanks to the graph theory, which is based on the based on the calculation of quantifiable parameters applied to the functional network studied, making it possible to assess its effectiveness.

To the knowledge of the investigators, no study has used graph theory applied to r-fMRI data in order to obtain parameters useful for the useful parameters for the individual prognosis of children who have to be operation for drug-resistant lesional epilepsy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-25
• Study First Submitted QC: 2020-06-25
• Study First Posted: 2020-06-30
• Study Start: 2020-10-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-24
• Last Update Posted: 2023-07-25
• Primary Completion: 2024-10
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patient aged between 6 and 18 years
• Receiving an MRI for lesional drug-resistant epilepsy
• Affiliated or beneficiary of a social security plan
• Whose parents or guardians have received information about the study and have given their express consent to participate in the study

Exclusion Criteria

• Contraindication to absolute or relative MRI (in particular, pregnant or breastfeeding women)
• History of intracranial surgery
• MRI performed under general anesthesia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine the prognostic value of topological parameters measured on local r-fMRI on the surgical success at one year of patients operated for drug-resistant epilepsy.	One year	The variables measured with functional MRI will correspond to topological parameters of functional connectivity measured locally at the level of the lesion: the degree, the clustering coefficient and path length. Surgical success will be evaluated by a score of 1 on the modified Engel classification at one year after surgery.

Trial Locations

Locations (1)

Fondation A De Rothschild; 🇫🇷 Paris, France