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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
History of Changes
  Purpose

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.


Condition Intervention
Childhood Absence Epilepsy [Pyknolepsy]
 Behavioral: Study of memory using MRI

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Anatomical and Functional MRI Study of Episodic Memory in Epileptic Compared to Normal Children

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Enrollment: 52
Study Start Date: October 2005
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Study of memory using MRI
    Study of memory using MRI
    Other Name: Study of memory using MRI
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).

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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.
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00242905

Locations
France
Service Hospitalier Frédéric Joliot (SHFJ)
Orsay, France, 91400
Necker Hospital
Paris, France, 75015
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Catherine CHIRON, MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:

Responsible Party: Yannick VACHER, Department of Clinical Research of developpement
ClinicalTrials.gov Identifier: NCT00242905     History of Changes
Other Study ID Numbers: P040203
Study First Received: October 20, 2005
Last Updated: April 29, 2011
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Memory
Epilepsy
Children
Magnetic resonance imaging
Functional magnetic resonance imaging

Additional relevant MeSH terms:
Epilepsy
Epilepsy, Absence
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Epilepsy, Generalized

ClinicalTrials.gov processed this record on May 23, 2013