Epilepsy in ChildrenCREIMNCT06202976
Mapping Epileptic Networks Using Multimodal Imaging
An observational study of Epilepsy in Children, run by Imagine Institute at 1 site in France.
Trial summary
Currently, mapping the epileptogenic zone is based on a comprehensive preoperative assessment involving clinical, imaging and electrophysiological examinations. To reduce the need for invasive stereoelectroencephalography (SEEG) explorations, electrophysiological and imaging methods have been developed, such as… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Epilepsy in Children
- What is being tested?
- Secondary data collection
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 14 Sep 2017to 13 Sep 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with refractory focal epilepsy, possibly due to lesions
Who may be able to join
- Be under 18 years of age on the day of inclusion.
- Present with one of the following forms of epilepsy:
- refractory focal lesional epilepsy
- rare non-lesional epilepsy
- Present abnormalities (spikes) on the intercritical EEG
- Have been selected by the "Epilepsy" multidisciplinary staff.
- In the case of refractory lesional epilepsy, be required to perform an EEG-video recording using intracranial electrodes (SEEG) as part of the pre-surgical workup.
- Be affiliated to a health insurance scheme.
Who cannot join
- Requiring general anesthesia for MRI
- Require sedation specifically for research
- Have generalized epilepsy
- Be deprived of liberty or under guardianship.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Necker - Enfants Malades Hospital
Paris, 75015
Nathalie Boddaert, Pr, +33 (0)1 44 49 51 75, nathalie.boddaert@aphp.fr
About this study
Currently, mapping the epileptogenic zone is based on a comprehensive preoperative assessment involving clinical, imaging and electrophysiological examinations.
To reduce the need for invasive stereoelectroencephalography (SEEG) explorations, electrophysiological and imaging methods have been developed, such as resting-state functional MRI (fMRI) coupled with electroencephalogram and arterial spin-labeling perfusion MRI (ASL-MRI).
Read more
It has been published that these new methods enable precise delineation of the epileptogenic zone and better preparation for surgery.
The aim is to determine whether, in children with focal lesional epilepsy, the combination of ASL-MRI-EEG and resting-state fMRI-EEG enables precise identification of the epileptogenic zone to be defined by SEEG, the current reference examination.
- Conditions
- Epilepsy in Children
- Being tested
- Secondary data collection
- Keywords
- Focal Epilepsy, Lesional Epilepsy, Nonlesional Epilepsy
- Medical subject headings
- Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secondary data collectionOther
clinical data
| Study group | Role | What they receive |
|---|---|---|
| Patients | Not described Receives: Other: Secondary data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine whether, in children with lesional focal epilepsy, the combination of ASL-MRI-EEG and resting-state fMRI-EEG can accurately identify the epileptogenic zone to be defined by SEEG, today's gold standard.
Measured: 15 years
Secondary outcomes (7)
Study the pathophysiology of resistant lesional epilepsies
Measurements of perfusion in ASL-MRI (inter and/or percritical) and the BOLD effect in resting-state fMRI
Measured: 15 years
Correlate cortical perfusion change on SL-ASMRI and BOLD signal abnormalities on resting-state fMRI
Measured: 15 years
Compare cortical perfusion abnormalities and resting-state fMRI based on EEG data in MRI.
Measured: 15 years
Correlate BOLD-MRI perfusion abnormalities with anatomical (DTI (tractography)) and functional (resting-state fMRI) brain connectivity abnormalities.
Measured: 15 years
Compare ASL-MRI and resting-state fMRI data coupled with EEG to the results of deep electrodes (intracranial EEG - SEEG), which are today's gold standard.
Measured: 15 years
Evaluate whether these data will eventually make it possible to reduce the frequency of intracranial EEG explorations (stereo EEG, subdural grids), with a view to replacing invasive deep electrodes in the future with multimodal MRI coupled to EEG in MRI.
Measured: 15 years
Improving understanding of the pathophysiology of rare non-lesional epilepsies
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start14 Sep 2017
- Primary completion13 Sep 2033 (estimated)
- Study completion13 Sep 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy in ChildrenStudies of the same condition, open and under way.
- 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
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imagine Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06202976
- Sponsor's protocol ID
- IM-RCM-2017-02
- Acronym
- CREIM
- Status last verified
- Apr 2025
- First submitted
- 2 Jan 2024
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping Epileptic Networks Using Multimodal Imaging
- ClinicalTrials.gov ID
- NCT06202976
- Acronym / sponsor ID
- CREIM / IM-RCM-2017-02
- Conditions
- Epilepsy in Children
- Keywords
- Focal Epilepsy, Lesional Epilepsy, Nonlesional Epilepsy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Imagine InstituteUniversity, hospital or other
- Study start
- 14 Sep 2017 (actual)
- Primary completion
- 13 Sep 2033 (estimated)
- Study completion
- 13 Sep 2033 (estimated)
- First posted
- 12 Jan 2024 (actual)
- 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.
Currently, mapping the epileptogenic zone is based on a comprehensive preoperative assessment involving clinical, imaging and electrophysiological examinations.
To reduce the need for invasive stereoelectroencephalography (SEEG) explorations, electrophysiological and imaging methods have been developed, such as resting-state functional MRI (fMRI) coupled with electroencephalogram and arterial spin-labeling perfusion MRI (ASL-MRI).
It has been published that these new methods enable precise delineation of the epileptogenic zone and better preparation for surgery.
The aim is to determine whether, in children with focal lesional epilepsy, the combination of ASL-MRI-EEG and resting-state fMRI-EEG enables precise identification of the epileptogenic zone to be defined by SEEG, the current reference examination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Secondary data collection |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with refractory focal epilepsy, possibly due to lesions
Key inclusion criteria (8 listed)
- Be under 18 years of age on the day of inclusion.
- Present with one of the following forms of epilepsy:
- Present abnormalities (spikes) on the intercritical EEG
- Have been selected by the "Epilepsy" multidisciplinary staff.
- In the case of refractory lesional epilepsy, be required to perform an EEG-video recording using intracranial electrodes (SEEG) as part of the pre-surgical workup.
Key exclusion criteria (4 listed)
- Requiring general anesthesia for MRI
- Require sedation specifically for research
- Have generalized epilepsy
- Be deprived of liberty or under guardianship.
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 |
|---|---|---|
| Secondary data collectionclinical data | Other | Patients |
Primary outcome
Determine whether, in children with lesional focal epilepsy, the combination of ASL-MRI-EEG and resting-state fMRI-EEG can accurately identify the epileptogenic zone to be defined by SEEG, today's gold standard.
Time frame: 15 years
7 secondary outcomes
Study the pathophysiology of resistant lesional epilepsies
Time frame: 15 years
Correlate cortical perfusion change on SL-ASMRI and BOLD signal abnormalities on resting-state fMRI
Time frame: 15 years
Compare cortical perfusion abnormalities and resting-state fMRI based on EEG data in MRI.
Time frame: 15 years
Correlate BOLD-MRI perfusion abnormalities with anatomical (DTI (tractography)) and functional (resting-state fMRI) brain connectivity abnormalities.
Time frame: 15 years
Compare ASL-MRI and resting-state fMRI data coupled with EEG to the results of deep electrodes (intracranial EEG - SEEG), which are today's gold standard.
Time frame: 15 years
Evaluate whether these data will eventually make it possible to reduce the frequency of intracranial EEG explorations (stereo EEG, subdural grids), with a view to replacing invasive deep electrodes in the future with multimodal MRI coupled to EEG in MRI.
Time frame: 15 years
Improving understanding of the pathophysiology of rare non-lesional epilepsies
Time frame: 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy in Children, run by Imagine Institute 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 8 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 17 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nathalie Boddaert, Pr (+33 (0)1 44 49 51 75, nathalie.boddaert@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine whether, in children with lesional focal epilepsy, the combination of ASL-MRI-EEG and resting-state fMRI-EEG can accurately identify the epileptogenic zone to be defined by SEEG, today's gold standard. (time frame: 15 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 17 Apr 2025.