Childhood Absence Epilepsy [Pyknolepsy]NCT00242905
Functional Magnetic Resonance Imaging (fMRI) Study of Memory in Children
An observational study of Childhood Absence Epilepsy [Pyknolepsy], run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Absence Epilepsy [Pyknolepsy]
- What is being tested?
- Study of memory using MRI
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 52 participants
- Where
- 2 sitesFrance
- Study dates
- Oct 2005to Feb 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- Any contra-indication to MRI or being claustrophobia or blind.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Service Hospitalier Frédéric Joliot (SHFJ)
Orsay, 91400
Necker Hospital
Paris, 75015
About this study
Official title: Anatomical and Functional MRI Study of Episodic Memory in Epileptic Compared to Normal Children
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.
Read the 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).
- Conditions
- Childhood Absence Epilepsy [Pyknolepsy]
- Being tested
- Study of memory using MRI
- Keywords
- Memory, Epilepsy, Children, Magnetic resonance imaging, Functional magnetic resonance imaging
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study of memory using MRIBehavioural
Study of memory using MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Childhood Absence Epilepsy [Pyknolepsy]Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Catherine CHIRON, MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00242905
- Sponsor's protocol ID
- P040203
- Status last verified
- Mar 2007
- First submitted
- 20 Oct 2005
- Last updated
- 2 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 8127430Hertz-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.
PubMed 11844736
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anatomical and Functional MRI Study of Episodic Memory in Epileptic Compared to Normal Children
- ClinicalTrials.gov ID
- NCT00242905
- Acronym / sponsor ID
- P040203
- Conditions
- Childhood Absence Epilepsy [Pyknolepsy]
- Keywords
- Memory, Epilepsy, Children, Magnetic resonance imaging, Functional magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 21 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Any contra-indication to MRI or being claustrophobia or blind.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study of memory using MRIStudy of memory using MRI | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2011.
- Background: PubMed 8127430Jambaque 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.
- Background: PubMed 11844736Hertz-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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine CHIRON, MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Absence Epilepsy [Pyknolepsy], run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00242905, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2011.