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

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ClinicalTrials.gov Identifier: NCT00242905
Recruitment Status : Completed
First Posted : October 21, 2005
Last Update Posted : May 2, 2011
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris

Tracking Information
First Submitted Date October 20, 2005
First Posted Date October 21, 2005
Last Update Posted Date May 2, 2011
Study Start Date October 2005
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Functional Magnetic Resonance Imaging (fMRI) Study of Memory in Children
Official Title Anatomical and Functional MRI Study of Episodic Memory in Epileptic Compared to Normal Children
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).

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Childhood Absence Epilepsy [Pyknolepsy]
Intervention Behavioral: Study of memory using MRI
Study of memory using MRI
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 29, 2011)
52
Original Enrollment
 (submitted: October 20, 2005)
40
Actual Study Completion Date February 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT00242905
Other Study ID Numbers P040203
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Yannick VACHER, Department of Clinical Research of developpement
Study Sponsor Assistance Publique - Hôpitaux de Paris
Collaborators Not Provided
Investigators
Principal Investigator: Catherine CHIRON, MD,PhD Assistance Publique - Hôpitaux de Paris
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date March 2007