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

NCT02799108 | Terminated

• 1 other identifier: AOL11-DR-WALLOIS
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Keywords

children; language; NIRS

Outcome Measures

Primary Outcomes (1)

• lateralization index

  3 months

Study Arms (1)

patients

EXPERIMENTAL

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

Device: NIRS; Device: fMRI

Interventions

NIRS DEVICE

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

patients

fMRI DEVICE

fMRI acquisition under the same stimulation conditions

patients

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

MeSH Terms

Conditions

Epilepsy; Language

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Communication; Behavior

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Fabrince WALLOIS, MD,PhD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 14, 2016
• Study Start: May 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: June 14, 2016

Record last verified: 2016-06

Locations

FR (1)