A Study of Hemodynamic Changes Using Near Infra-red Spectrometry (NIRS) in Infantile Epilepsy Spasms

• Conditions: Epilepsy
• Interventions: Device: NIRS

• Registration Number: NCT02899832
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

This study will included 20 children presenting with epilepsy with spasms. It aims to offer these children, non invasively and without supplementary examinations, a recording of local and cerebral hemodynamic changes concomitant with an electroencephalographic recording during epileptic episodes. This will be carried out by combining optical imaging using near infra-red spectroscopy (NIRS) with electroencephalography (EEG), in a simultaneous high-resolution (HR) recording.

This study is among those based on multimodal analyses of epilepsy, combining methods of analysis of electrical activity (electrical imaging) and hemodynamics (optical imaging).

Surface electroencephalography (EEG) is a precious tool enabling the study of neuronal dysfunction from a functional point view. It is used in the routine follow-up of children with epilepsy. Optical imaging is a promising medical imaging technique. It uses light in the spectral regions of near infra-red as a source of radiation. It is quantitative, rapid, non invasive, and inoffensive which could easily be used at the child's bedside or in a clinical setting and can provide metabolic information about cerebral function.

This study is multidisciplinary, which calls upon the skills of neurophysiologists, biophysicists, and clinicians

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-21
• Study First Submitted: 2016-09-05
• Study First Submitted QC: 2016-09-08
• Study First Posted: 2016-09-14
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-09
• Last Update Posted: 2018-08-10
• Primary Completion: 2020-02
• Study Completion: 2020-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Children between 3 and 6 years old presenting infantile spasms according to the Classification of the International League Against Epilepsy

Exclusion Criteria

• Children younger than 3 months and older than 6 years of age, refusal of one of the parents, and dermatosis of the scalp

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NIRS	NIRS	Near Infra Red Spectroscopy.

Primary Outcome Measures

Name	Time	Method
changes in Hbr	Day 0	hemodynamic changes in \[Hbr\] before spasms, during spasms, and after spasms
changes in HbO	Day 0	hemodynamic changes in \[HbO\] before spasms, during spasms, and after spasms

Trial Locations

Locations (2)

Fondation Ophtalmologique Rothshild; 🇫🇷 Paris, France

CHU Amiens; 🇫🇷 Amiens, France