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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00242905
Other study ID # P040203
Secondary ID
Status Completed
Phase N/A
First received October 20, 2005
Last updated April 29, 2011
Start date October 2005
Est. completion date February 2009

Study information

Verified date March 2007
Source Assistance Publique - Hôpitaux de Paris
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Observational

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date February 2009
Est. primary completion date February 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Years to 18 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Behavioral:
Study of memory using MRI
Study of memory using MRI

Locations

Country Name City State
France Service Hospitalier Frédéric Joliot (SHFJ) Orsay
France Necker Hospital Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (2)

Hertz-Pannier L, Chiron C, Jambaqué 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. — View Citation

Jambaqué 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. — View Citation