Analysis of Lateralization of Language in Epileptic Children by Near-infrared Spectroscopy (NIRS) (LANGLAT)
Primary Purpose
Epilepsy
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
NIRS
fMRI
Sponsored by
About this trial
This is an interventional basic science trial for Epilepsy focused on measuring children, language, NIRS
Eligibility Criteria
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
Sites / Locations
- CHU Amiens
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
patients
Arm Description
children with drug-resistant partial epilepsy, in whom preoperative assessment is indicated
Outcomes
Primary Outcome Measures
lateralization index
Secondary Outcome Measures
Full Information
NCT ID
NCT02799108
First Posted
June 9, 2016
Last Updated
June 9, 2016
Sponsor
Centre Hospitalier Universitaire, Amiens
1. Study Identification
Unique Protocol Identification Number
NCT02799108
Brief Title
Analysis of Lateralization of Language in Epileptic Children by Near-infrared Spectroscopy (NIRS)
Acronym
LANGLAT
Official Title
Analysis of Lateralization of Language in Epileptic Children by Near-infrared Spectroscopy (NIRS)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Terminated
Why Stopped
inclusion difficulty
Study Start Date
May 2012 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
children, language, NIRS
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patients
Arm Type
Experimental
Arm Description
children with drug-resistant partial epilepsy, in whom preoperative assessment is indicated
Intervention Type
Device
Intervention Name(s)
NIRS
Intervention Description
High-resolution EEG-fNIRS recording lasting a maximum of 30 minutes by using expressive and receptive language paradigms
Intervention Type
Device
Intervention Name(s)
fMRI
Intervention Description
fMRI acquisition under the same stimulation conditions
Primary Outcome Measure Information:
Title
lateralization index
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabrince WALLOIS, MD,PhD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
12. IPD Sharing Statement
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Analysis of Lateralization of Language in Epileptic Children by Near-infrared Spectroscopy (NIRS)
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