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

NCT04451278 | Recruiting

• 1 other identifier: 2020-A01561-38
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  One year

Study Arms (1)

Resting-state functional MRI (r-fMRI)

The MRI examination will be performed on a 3T multi-parametric MRI. Compared to the standard protocol, patients will benefit from an additional fMRI-r sequence, called resting state, and performed before injection of gadoline contrast. A neuropsychological evaluation is performed as part of the 6 months prior to the procedure. These data will be used as a basis for the evaluation of language visual and language recovery.

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients from 6 to 18 years old receiving an MRI as part of a preoperative assessment of lesion epilepsy

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation A De Rothschild

Paris, PARIS, 75019, France

RECRUITING

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Sidney KRYSTAL

  Adolphe de Rothschild Fondation Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sidney KRYSTAL

CONTACT

01 48 03 65 65; skrystal@for.paris

Amelie YAVCHITZ

CONTACT

01 48 03 65 65; ayavchitz@for.paris

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: June 30, 2020
• Study Start: October 30, 2020
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)