Functional Magnetic Resonance Imaging (fMRI) Study of Mem... | NCT00242905

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

NCT00242905

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

May 2, 2011Estimated

Enrollment

52Actual

Phase

Not provided

Conditions

Childhood Absence Epilepsy [Pyknolepsy]

Interventions

Study of memory using MRI

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2005

Primary Completion Date

Feb 2009Actual

Completion Date

Feb 2009Actual

First Submitted Date

Oct 20, 2005

First Submission Date that Met QC Criteria

Oct 20, 2005

First Posted Date

Oct 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 29, 2011

Last Update Posted Date

May 2, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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):

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

52Actual

Name	Type	Description	Arm Group Labels	Other Names
Study of memory using MRI	Behavioral	Study of memory using MRI

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Catherine CHIRON, MD,PhD	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service Hospitalier Frédéric Joliot (SHFJ)		Orsay		91400	France
Necker Hospital

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
8127430	Background	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.
11844736	Background	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.

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases