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

Epilepsy Clinical Trial

— LANGLAT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02799108
• Other study ID #: AOL11-DR-WALLOIS
• Status: Terminated
• Phase: N/A
• First received: June 9, 2016
• Last updated: June 9, 2016
• Start date: May 2012
• Est. completion date: January 2015

Study information

• Verified date: June 2016
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Epilepsy

Intervention

Device:
• NIRS
High-resolution EEG-fNIRS recording lasting a maximum of 30 minutes by using expressive and receptive language paradigms
• fMRI
fMRI acquisition under the same stimulation conditions

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lateralization index		3 months	No