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

Epilepsy Clinical Trial

— NIRS Epilepsie  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02814331
• Other study ID #: PHRCN11-DR-WALLOIS
• Status: Completed
• Start date: October 14, 2011
• Est. completion date: April 24, 2015

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: April 24, 2015
• Est. primary completion date: April 24, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy

Intervention

Device:
• multimodal high-resolution EEG-NIRS

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	multimodal high-resolution EEG-NIRS	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.	Day 0
Secondary	Functional MRI	to analyse the temporal dynamics of haemodynamic changes surrounding epileptic spikes.	Day 0