Benign Childhood Epilepsy With Centro-temporal Spikes (BCECTS)DYNAMATNCT02648529
Brain Maturation in Children With Localization Related Epilepsy
A study testing MRI, functional MRI (fMRI) and neuropsychological assessment in people with Benign Childhood Epilepsy With Centro-temporal Spikes (BCECTS) and Focal Cryptogenic Epilepsy of Childhood, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
This project intends to investigate children with idiopathic and cryptogenic localization related epilepsies, using a longitudinal assessment of structural and functional MRI data, in relation to neuropsychological evaluation. Read more about this study
- Who is it for?
- Ages 6 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Benign Childhood Epilepsy With Centro-temporal Spikes (BCECTS), Focal Cryptogenic Epilepsy of Childhood, Cryptogenic Epilepsy of Childhood
- What is being tested?
- MRI, functional MRI (fMRI) and neuropsychological assessment
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2008to 7 Dec 2018
- Phase
- Interventional
- 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 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- motivation to participate in the study for 5 years
- for patients - one of the following diagnostics - BCECTS (benign childhood epilepsy with centro-temporal spikes), focal cryptogenic epilepsy of childhood, Panayiotopoulos syndrome, diagnosis established according to the current diagnostic criteria (ILAE, 1989)
- for patients - no anti-epileptic drug for 24 months
- normal MRI if available before inclusion
- signed consent by on of the parents
Who cannot join
- associated neurological and psychiatric diseases
- other epileptic syndromes
- other chronic severe disease
- contra-indication for performing an MRI examination
- claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dynamic Regional Brain Maturation in Children With Localization Related Epilepsy
This project intends to investigate children with idiopathic and cryptogenic localization related epilepsies, using a longitudinal assessment of structural and functional MRI data, in relation to neuropsychological evaluation. The rationale is primarily based on: 1) the frequent observation of selective cognitive dysfunctions in such children, the pathophysiology of which remains largely uncertain; 2) the recent major advances in the MRI investigation of brain maturation showing striking age and region dependant patterns.
The primary hypothesis is that some children with localization related epilepsies suffer from altered maturation in the epileptic brain regions, and that this abnormal maturation affects their cognitive abilities. 100 children with localization related epilepsies and 100 matched controls will be prospectively enrolled during the first two years of the disease (for patients) and benefit from a comprehensive phenotypic and neuropsychological evaluation once a year for 5 years. The brain maturation of these children will be longitudinally assessed using structural and functional MRI, and correlated with neuropsychological data. Investigators hope to demonstrate that children with localization related epilepsies and cognitive dysfunctions suffer from an abnormal brain maturation in regions underlying the epileptic activity and the altered cognitive processes. The finding could partly bridge the gap between these two abnormalities and help better understand their interaction and respective dynamic. Once validated, the study of regional brain maturation in children with epilepsy might be further used as a reliable surrogate marker or predictor of associated cognitive dysfunction.
- Conditions
- Benign Childhood Epilepsy With Centro-temporal Spikes (BCECTS), Focal Cryptogenic Epilepsy of Childhood, Cryptogenic Epilepsy of Childhood
- Being tested
- MRI, functional MRI (fMRI), neuropsychological assessment
- Keywords
- Benign childhood epilepsy with centro-temporal spikes, rolandic epilepsy, brain development, DTI, functional MRI, structural MRI, idiopathic focal epilepsy, cryptogenic epilepsy of childhood
- Medical subject headings
- Epilepsy, Rolandic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIProcedure or surgery
Patients are investigated with the following sequences:
- High-resolution 3D T1-weighted anatomical MRI.
- DTI with 48 directions (to examine white matter)
functional MRI (fMRI)Procedure or surgery
fMRI investigations will be focused on :
- language: investigation on possible atypical language networks in children with epilepsy. The fMRI task is a silent verb generation.
- Social cognition: investigations on social cognition skills
- Memory :
- Declarative memory: investigations on the pattern of activations in the brain associated with successful memory formation and changes from childhood to adolescence
- Working memory: A verbal and a spatial working memory task has been chosen, and is an adaptation of two published cross-sectional studies of working memory from Gabrieli and Sowell groups.
neuropsychological assessmentBehavioural
Patients undergo a repeated annual neuropsychological assessment over the five years of their participation in the project.
| Study group | Role | What they receive |
|---|---|---|
| Patients with BCECTS | Experimental | Patients with BCECTS on which MRI, fMRI and neuropsychological assessment will be performed Receives: Procedure: MRI; Procedure: functional MRI (fMRI); Behavioral: neuropsychological assessment |
| Healthy volunteers | Other | Healthy volunteers on which MRI, fMRI and neuropsychological assessment will be performed Receives: Procedure: MRI; Procedure: functional MRI (fMRI); Behavioral: neuropsychological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of grey/white matter volume
The aim is to evaluate structural brain maturation. All subjects will benefit from a 3D-T1 1,5 Tesla MRI and 48-directions Diffusion Tensor Imaging (DTI). We will calculate parametric maps of individual regional changes of grey/white matter fractions over time. This study aims to detect a significant difference in the rate of grey/white matter volume change over the epileptic region. We will further correlate a number of neuropsychological and clinical variables with the parametric maps of brain maturation. There will be annual measures up to 5 years after inclusion.
Measured: At 5 years
Secondary outcomes (4)
Changes in fMRI activation of language areas in brain during cognitive tasks
The aim is to evaluate functional brain maturation of language. All subjects will benefit from the functional MRI (fMRI) evaluation of the cognitive tasks. Changes in fMRI activation over time will be studied at the group level, taking into account all potentially relevant variables. This outcomme will be assessed at year 1, 3 and 5 after inclusion.
Measured: At 5 years
Changes in fMRI activation of social cognition areas in brain during cognitive tasks
The aim is to evaluate functional Brain Maturation of social cognition. All subjects will benefit from the functional MRI (fMRI) evaluation of the cognitive tasks. Changes in fMRI activation over time will be studied at the group level, taking into account all potentially relevant variables. This outcomme will be assessed at year 1, 3 and 5 after inclusion.
Measured: At 5 years
Changes in fMRI activation of Working memory areas in brain during cognitive tasks
The aim is to evaluate Functional Brain Maturation of Working memory. All subjects will benefit from the functional MRI (fMRI) evaluation of the cognitive tasks. Changes in fMRI activation over time will be studied at the group level, taking into account all potentially relevant variables. This outcomme will be assessed at year 1, 3 and 5 after inclusion.
Measured: At 5 years
Changes in fMRI activation of declarative memory areas in brain during cognitive tasks
The aim is to evaluate Functional Brain Maturation of declarative memory. All subjects will benefit from the functional MRI (fMRI) evaluation of the cognitive tasks. Changes in fMRI activation over time will be studied at the group level, taking into account all potentially relevant variables. This outcomme will be assessed at year 1, 3 and 5 after inclusion.
Measured: At 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startSep 2008
- Primary completion7 Dec 2018
- Study completion7 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Childhood Epilepsy With Centro-temporal Spikes (BCECTS)Studies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvain RHEIMS, Principal investigator, Service d'épileptologie fonctionnelle, Hôpital Pierre Wertheimer, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648529
- Sponsor's protocol ID
- 2011-700
- Acronym
- DYNAMAT
- Status last verified
- Dec 2018
- First submitted
- 2 Dec 2015
- Last updated
- 21 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Regional Brain Maturation in Children With Localization Related Epilepsy
- ClinicalTrials.gov ID
- NCT02648529
- Acronym / sponsor ID
- DYNAMAT / 2011-700
- Conditions
- Benign Childhood Epilepsy With Centro-temporal Spikes (BCECTS), Focal Cryptogenic Epilepsy of Childhood, Cryptogenic Epilepsy of Childhood
- Keywords
- Benign childhood epilepsy with centro-temporal spikes, rolandic epilepsy, brain development, DTI, functional MRI, structural MRI, idiopathic focal epilepsy, cryptogenic epilepsy of childhood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- 7 Dec 2018 (actual)
- Study completion
- 7 Dec 2018 (actual)
- First posted
- 7 Jan 2016 (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.
This project intends to investigate children with idiopathic and cryptogenic localization related epilepsies, using a longitudinal assessment of structural and functional MRI data, in relation to neuropsychological evaluation. The rationale is primarily based on: 1) the frequent observation of selective cognitive dysfunctions in such children, the pathophysiology of which remains largely uncertain; 2) the recent major advances in the MRI investigation of brain maturation showing striking age and region dependant patterns.
The primary hypothesis is that some children with localization related epilepsies suffer from altered maturation in the epileptic brain regions, and that this abnormal maturation affects their cognitive abilities. 100 children with localization related epilepsies and 100 matched controls will be prospectively enrolled during the first two years of the disease (for patients) and benefit from a comprehensive phenotypic and neuropsychological evaluation once a year for 5 years. The brain maturation of these children will be longitudinally assessed using structural and functional MRI, and correlated with neuropsychological data. Investigators hope to demonstrate that children with localization related epilepsies and cognitive dysfunctions suffer from an abnormal brain maturation in regions underlying the epileptic activity and the altered cognitive processes. The finding could partly bridge the gap between these two abnormalities and help better understand their interaction and respective dynamic. Once validated, the study of regional brain maturation in children with epilepsy might be further used as a reliable surrogate marker or predictor of associated cognitive dysfunction.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with BCECTS | Experimental | Procedure: MRI, Procedure: functional MRI (fMRI), Behavioral: neuropsychological assessmentPatients with BCECTS on which MRI, fMRI and neuropsychological assessment will be performed |
| Healthy volunteers | Other | Procedure: MRI, Procedure: functional MRI (fMRI), Behavioral: neuropsychological assessmentHealthy volunteers on which MRI, fMRI and neuropsychological assessment will be performed |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- motivation to participate in the study for 5 years
- for patients - one of the following diagnostics - BCECTS (benign childhood epilepsy with centro-temporal spikes), focal cryptogenic epilepsy of childhood, Panayiotopoulos syndrome, diagnosis established according to the current diagnostic criteria (ILAE, 1989)
- for patients - no anti-epileptic drug for 24 months
- normal MRI if available before inclusion
- signed consent by on of the parents
Key exclusion criteria (5 listed)
- associated neurological and psychiatric diseases
- other epileptic syndromes
- other chronic severe disease
- contra-indication for performing an MRI examination
- claustrophobia
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 |
|---|---|---|
| MRIPatients are investigated with the following sequences: * High-resolution 3D T1-weighted anatomical MRI. * DTI with 48 directions (to examine white matter) | Procedure or surgery | Healthy volunteers, Patients with BCECTS |
| functional MRI (fMRI)fMRI investigations will be focused on : * language: investigation on possible atypical language networks in children with epilepsy. The fMRI task is a silent verb generation. * Social cognition: investigations on social cognition skills * Memory : * Declarative memory: investigations on the pattern of activations in the brain associated with successful memory formation and changes from childhood to adolescence * Working memory: A verbal and a spatial working memory task has been chosen, and is an adaptation of two published cross-sectional studies of working memory from Gabrieli and Sowell groups. | Procedure or surgery | Healthy volunteers, Patients with BCECTS |
| neuropsychological assessmentPatients undergo a repeated annual neuropsychological assessment over the five years of their participation in the project. | Behavioural | Healthy volunteers, Patients with BCECTS |
Primary outcome
Rate of grey/white matter volume
Time frame: At 5 years
The aim is to evaluate structural brain maturation. All subjects will benefit from a 3D-T1 1,5 Tesla MRI and 48-directions Diffusion Tensor Imaging (DTI). We will calculate parametric maps of individual regional changes of grey/white matter fractions over time. This study aims to detect a significant difference in the rate of grey/white matter volume change over the epileptic region. We will further correlate a number of neuropsychological and clinical variables with the parametric maps of brain maturation. There will be annual measures up to 5 years after inclusion.
4 secondary outcomes
Changes in fMRI activation of language areas in brain during cognitive tasks
Time frame: At 5 years
Changes in fMRI activation of social cognition areas in brain during cognitive tasks
Time frame: At 5 years
Changes in fMRI activation of Working memory areas in brain during cognitive tasks
Time frame: At 5 years
Changes in fMRI activation of declarative memory areas in brain during cognitive tasks
Time frame: At 5 years
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 21 Dec 2018.
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.
Sylvain RHEIMS principal investigator
Service d'épileptologie fonctionnelle, Hôpital Pierre Wertheimer, Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI, functional MRI (fMRI) and neuropsychological assessment in people with Benign Childhood Epilepsy With Centro-temporal Spikes (BCECTS) and Focal Cryptogenic Epilepsy of Childhood, run by Hospices Civils de Lyon at 1 site 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 5 inclusion and 5 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 21 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does the primary outcome measure?
Rate of grey/white matter volume (time frame: At 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2018.