- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00242905
Functional Magnetic Resonance Imaging (fMRI) Study of Memory in Children
Anatomical and Functional MRI Study of Episodic Memory in Epileptic Compared to Normal Children
Study Overview
Status
Conditions
Intervention / Treatment
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):
- complete neuropsychological evaluation including episodic memory,
- 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,
- 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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Orsay, France, 91400
- Service Hospitalier Frédéric Joliot (SHFJ)
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Paris, France, 75015
- Necker Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Collaborators and Investigators
Investigators
- Principal Investigator: Catherine CHIRON, MD,PhD, Assistance Publique - Hôpitaux de Paris
Publications and helpful links
General Publications
- Jambaque I, Dellatolas G, Dulac O, Ponsot G, Signoret JL. Verbal and visual memory impairment in children with epilepsy. Neuropsychologia. 1993 Dec;31(12):1321-37. doi: 10.1016/0028-3932(93)90101-5.
- Hertz-Pannier L, Chiron C, Jambaque I, Renaux-Kieffer V, Van de Moortele PF, Delalande O, Fohlen M, Brunelle F, Le Bihan D. Late plasticity for language in a child's non-dominant hemisphere: a pre- and post-surgery fMRI study. Brain. 2002 Feb;125(Pt 2):361-72. doi: 10.1093/brain/awf020.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P040203
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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