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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2015-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Epilepsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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patients

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

Group Type EXPERIMENTAL

NIRS

Intervention Type DEVICE

High-resolution EEG-fNIRS recording lasting a maximum of 30 minutes by using expressive and receptive language paradigms

fMRI

Intervention Type DEVICE

fMRI acquisition under the same stimulation conditions

Interventions

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NIRS

High-resolution EEG-fNIRS recording lasting a maximum of 30 minutes by using expressive and receptive language paradigms

Intervention Type DEVICE

fMRI

fMRI acquisition under the same stimulation conditions

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No