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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04451278

Acronym

RESPIRE

Enrollment

200

Registered

2020-06-30

Start date

2020-10-30

Completion date

2028-04-30

Last updated

2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

France

Contacts

Primary ContactSidney KRYSTAL

skrystal@for.paris01 48 03 65 65

Backup ContactAmelie YAVCHITZ

ayavchitz@for.paris01 48 03 65 65

Outcome results