Electrohaemodynamic Activity in Epileptic Children : Combined Video-EEG and Near-infrared Spectroscopy (NIRS) Analysis

Completed

• Conditions: Epilepsy
• Interventions: Device: multimodal high-resolution EEG-NIRS

• Registration Number: NCT02814331
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

Evaluate the contribution of multimodal high-resolution EEG-NIRS electrical and local haemodynamic analysis to spatial localization of epileptogenic foci

Detailed Description

This study is designed to evaluate the contribution of multimodal high-resolution EEG-NIRS electrical and local haemodynamic analysis (HR-EEG, HR-NIRS) to spatial localization of epileptogenic foci in order to perform multimodal mapping and localization of interictal spikes (by HR-EEG source reconstruction) with the clinical prospects of guiding the SEEG electrode implantation strategy prior to surgery in children with drug-refractory partial epilepsy.

Study Timeline

• Study Start: 2011-10-14
• Primary Completion: 2015-04-24
• Study Completion: 2015-04-24
• Study First Submitted: 2016-06-23
• Study First Submitted QC: 2016-06-23
• Study First Posted: 2016-06-27
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-02
• Last Update Posted: 2018-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• Children between the ages of 6 and 18 years
• with drug-refractory partial epilepsy, presenting interictal spikes on standard EEG recordings.

Exclusion Criteria

• Children with a serious congenital malformation.
• Refusal from one of the parents or the child.
• Children with generalized epilepsy or diffuse interictal spikes.
• Children with severely impaired general status and vital functions.
• Children with dermatosis of the face or scalp.
• Children under the age of 6 years or adults over the age of 18 years.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
not symptomatic partial epilepsy	multimodal high-resolution EEG-NIRS	whose brain MRI is normal multimodal high-resolution EEG-NIRS
symptomatic partial epilepsy	multimodal high-resolution EEG-NIRS	whose brain MRI is abnormal multimodal high-resolution EEG-NIRS

Primary Outcome Measures

Name	Time	Method
multimodal high-resolution EEG-NIRS	Day 0	to evaluate the contribution of multimodal high-resolution EEG-NIRS electrical and local haemodynamic analysis (HR-EEG, HR-NIRS) to spatial localization of epileptogenic foci in order to perform multimodal mapping and localization of interictal spikes (by HR-EEG source reconstruction) with the clinical prospects of guiding the SEEG electrode implantation strategy prior to surgery in children with drug-refractory partial epilepsy.

Secondary Outcome Measures

Name	Time	Method
Functional MRI	Day 0	to analyse the temporal dynamics of haemodynamic changes surrounding epileptic spikes.

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France