Analysis of Lateralization of Language in Epileptic Children by Near-infrared Spectroscopy (NIRS)

Not Applicable

Terminated

• Conditions: Epilepsy
• Interventions: Device: NIRS; Device: fMRI

• Registration Number: NCT02799108
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

Recent data published by various laboratories as well as our preliminary data tend to prove that near-infrared spectroscopy can be used to determine the lateralization of language as part of the preoperative assessment for drug-resistant epilepsy. The reference test used up until very recently was the Wada test, which consisted of injecting an anaesthetic (generally amobarbital sodium) into one of the internal carotid arteries (right or left) in order to determine the predominant cerebral hemisphere for language. This invasive test has been progressively replaced by fMRI, which is nevertheless difficult to perform in children under the age of 7 years. NIRS therefore appears to be a useful alternative, which, in contrast with fMRI, can be easily repeated and allows simple investigation of the various facets of language (e.g. expressive, receptive). In the GRAMFC unit, the investigators have acquired a unique know-how in the field of high-resolution NIRS, both in epilepsy and in the development of language structures.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2016-06
• Study First Submitted: 2016-06-09
• Study First Submitted QC: 2016-06-09
• Last Update Submitted: 2016-06-09
• Study First Posted: 2016-06-14
• Last Update Posted: 2016-06-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• children with drug-resistant partial epilepsy, in whom preoperative assessment is indicated.

Exclusion Criteria

• All children with severe congenital malformation
• Any refusal of a parent or child
• Any child with generalized epilepsy or diffuse interictal spikes
• Any child with a serious deterioration in the general condition and vital functions
• Any child with dermatitis of the face or scalp
• Children under 6 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients	NIRS	children with drug-resistant partial epilepsy, in whom preoperative assessment is indicated
patients	fMRI	children with drug-resistant partial epilepsy, in whom preoperative assessment is indicated

Primary Outcome Measures

Name	Time	Method
lateralization index	3 months

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France