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

Epilepsy Clinical Trial

— RESPIRE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04451278
• Other study ID #: 2020-A01561-38
• Status: Recruiting
• Start date: October 30, 2020
• Est. completion date: April 2026

Study information

• Verified date: July 2023
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: Sidney KRYSTAL
• Phone: 01 48 03 65 65
• Email: skrystal[@]for.paris
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2026
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy

Locations

Country	Name	City	State
France	Fondation A De Rothschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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