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

NCT ID: NCT04451278

Last Updated: 2026-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-30

Study Completion Date

2028-04-30

Brief Summary

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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

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Conditions

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Epilepsy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sidney KRYSTAL

Role: PRINCIPAL_INVESTIGATOR

Adolphe de Rothschild Fondation Hospital

Locations

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Fondation A De Rothschild

Paris, PARIS, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Sidney KRYSTAL

Role: CONTACT

01 48 03 65 65 ext. + 33

Amelie YAVCHITZ

Role: CONTACT

01 48 03 65 65 ext. + 33

Facility Contacts

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Amelie YAVCHITZ

Role: primary

0148036431

Other Identifiers

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2020-A01561-38

Identifier Type: -

Identifier Source: org_study_id

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