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Recruiting NCT04451278

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

Observational Epilepsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Epilepsy. Basic parameters: 6 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • 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. [Time frame: One year]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

France · 1 center
  • Fondation A De Rothschild — Paris

Identifiers

NCT: NCT04451278 · 2020-A01561-38

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗