Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT00242905
Status:
COMPLETED
Last Update Posted:
2011-05-02
First Post:
2005-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Functional Magnetic Resonance Imaging (fMRI) Study of Memory in Children
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Anatomical and Functional MRI Study of Episodic Memory in Epileptic Compared to Normal Children
Status:
COMPLETED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Memory is a cognitive function whose development is still poorly documented in children, but which is often disturbed in temporal epilepsy. There are no studies about the disorders of episodic memory. The investigations using functional MRI (fMRI) are scarce, they do not involve this field and none are dedicated to children. The objectives of this project are to study the neuronal networks involved in episodic memory in normal children, as well as the disorders of episodic memory in children with epilepsy and the mechanisms of cognitive and cerebral reorganization in epilepsy.
Detailed Description:
Twenty children aged from 6 to 18 years with temporal and/or frontal epilepsy and 20 normal children in the same age range will undergo the following examinations in a unique day in the Unit Hospital F. JOLIOT(CEA in ORSAY, France):
1. complete neuropsychological evaluation including episodic memory,
2. structural MRI to quantify, using VBM, the potential abnormalities of the anatomical structures, to perform cognitive-morphological correlations, and to localize the neuronal networks activated on fMRI,
3. functional MRI using an original task of episodic memory, specifically dedicated to children and being under behavioural validation laboratory.
The analysis of fMRI data will be performed using SPM and taking into account the existence of epilepsy or not, of cerebral lesion or not, age, handedness, the side and location of epileptogenic focus, the age of seizure onset, and the type of antiepileptic treatment.
This study has been approved by the Ethic Committee in september 2004 (CCPPRB BICETRE, promotion of ASSISTANCE PUBLIQUE - HOPITAUX de PARIS).
1. complete neuropsychological evaluation including episodic memory,
2. structural MRI to quantify, using VBM, the potential abnormalities of the anatomical structures, to perform cognitive-morphological correlations, and to localize the neuronal networks activated on fMRI,
3. functional MRI using an original task of episodic memory, specifically dedicated to children and being under behavioural validation laboratory.
The analysis of fMRI data will be performed using SPM and taking into account the existence of epilepsy or not, of cerebral lesion or not, age, handedness, the side and location of epileptogenic focus, the age of seizure onset, and the type of antiepileptic treatment.
This study has been approved by the Ethic Committee in september 2004 (CCPPRB BICETRE, promotion of ASSISTANCE PUBLIQUE - HOPITAUX de PARIS).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: