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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02799108

Acronym

LANGLAT

Enrollment

Registered

2016-06-14

Start date

2012-05-31

Completion date

2015-01-31

Last updated

2016-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

children, language, NIRS

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.

Interventions

DEVICENIRS

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

DEVICEfMRI

fMRI acquisition under the same stimulation conditions

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
lateralization index	3 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026