Functional Magnetic Resonance Imaging (fMRI) Study of Memory in Children

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00242905
First received: October 20, 2005
Last updated: April 29, 2011
Last verified: March 2007

October 20, 2005
April 29, 2011
October 2005
February 2009   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00242905 on ClinicalTrials.gov Archive Site
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Not Provided
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Functional Magnetic Resonance Imaging (fMRI) Study of Memory in Children
Anatomical and Functional MRI Study of Episodic Memory in Epileptic Compared to Normal Children

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.

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).

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Inclusion Criteria:

  • Parents or legal tutors of the children having given written consent to participate to the study, after having being fully informed.
  • Patients presenting with a temporal and/or frontal epilepsy and being able to perform the tasks of the protocol.
  • Controls being recruited among brothers, sisters, and friends of the patients and being right-handlers, without any neurological history or learning disorders.

Exclusion Criteria:

  • Any contra-indication to MRI or being claustrophobia or blind.
Childhood Absence Epilepsy [Pyknolepsy]
Behavioral: Study of memory using MRI
Study of memory using MRI
Other Name: Study of memory using MRI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
February 2009
February 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Parents or legal tutors of the children having given written consent to participate to the study, after having being fully informed.
  • Patients presenting with a temporal and/or frontal epilepsy and being able to perform the tasks of the protocol.
  • Controls being recruited among brothers, sisters, and friends of the patients and being right-handlers, without any neurological history or learning disorders.

Exclusion Criteria:

  • Any contra-indication to MRI or being claustrophobia or blind.
Both
6 Years to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00242905
P040203
Yes
Yannick VACHER, Department of Clinical Research of developpement
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Catherine CHIRON, MD,PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP