Epilepsy in Children Clinical Trial
— CREIMOfficial title:
Mapping Epileptic Networks Using Multimodal Imaging
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.
Status | Recruiting |
Enrollment | 75 |
Est. completion date | September 13, 2030 |
Est. primary completion date | September 13, 2030 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Years |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - Requiring general anesthesia for MRI - Require sedation specifically for research - Have generalized epilepsy - Be deprived of liberty or under guardianship. |
Country | Name | City | State |
---|---|---|---|
France | Necker - Enfants Malades Hospital | Paris |
Lead Sponsor | Collaborator |
---|---|
Imagine Institute |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 15 years | ||
Secondary | 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 | 15 years | |
Secondary | Correlate cortical perfusion change on SL-ASMRI and BOLD signal abnormalities on resting-state fMRI | 15 years | ||
Secondary | Compare cortical perfusion abnormalities and resting-state fMRI based on EEG data in MRI. | 15 years | ||
Secondary | Correlate BOLD-MRI perfusion abnormalities with anatomical (DTI (tractography)) and functional (resting-state fMRI) brain connectivity abnormalities. | 15 years | ||
Secondary | 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. | 15 years | ||
Secondary | 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. | 15 years | ||
Secondary | Improving understanding of the pathophysiology of rare non-lesional epilepsies | 15 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04770337 -
Pivotal-Safety and Therapeutic Measures of tDCS in Patients With Refractory Focal Epilepsy
|
N/A | |
Recruiting |
NCT05885646 -
Effect of Sulthiame on EEG in Childhood Epilepsy Syndromes
|
||
Completed |
NCT04545346 -
The Potential of a Low Glutamate Diet as a Treatment for Pediatric Epilepsy
|
N/A | |
Completed |
NCT06400966 -
The Effect of Jigsaw Technique on Childhood Epileptic Seizure Management Knowledge and Attitudes of Nursing Students
|
N/A | |
Not yet recruiting |
NCT06388577 -
The Effect of the Training Programme Based on the Health Promotion Model Given to Parents
|
N/A | |
Not yet recruiting |
NCT06402526 -
Evaluating the Efficacy of a Mobile Epilepsy Education Application
|
N/A | |
Terminated |
NCT04639310 -
XEN496 (Ezogabine) in Children With KCNQ2 Developmental and Epileptic Encephalopathy
|
Phase 3 | |
Recruiting |
NCT06444126 -
The Incidence And Risk Factors Of Recurrent Febrile Seizures And Epilepsy Following Febrile Seizures
|
||
Withdrawn |
NCT04308252 -
Comparison of Microbiome Composition and Biomarkers in Pharmaco Resistant and Pharmaco-Sensitive Epilepsy
|
||
Recruiting |
NCT06300814 -
The Effect of Exercise and Music on Sleep, Quality of Life and Emotional State in Children With Epilepsy
|
N/A | |
Active, not recruiting |
NCT03916848 -
Novel Network Analysis of Intracranial Stereoelectroencephalography
|
N/A | |
Recruiting |
NCT05439876 -
Getting SMART for Pediatric Epilepsy
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT06455384 -
The Genetics Navigator: Evaluating a Digital Platform for Genomics Health Services
|
N/A | |
Recruiting |
NCT05323682 -
Physical Excercise Program in Children With Drug-resistant Epilepsy
|
N/A | |
Recruiting |
NCT04584385 -
Advanced EEG Technology in Childhood Epilepsy
|
||
Not yet recruiting |
NCT04219930 -
Nucleotide Protein -3 in Epileptic Children
|
||
Completed |
NCT04020484 -
Making Mindfulness Matter© in Children With Epilepsy
|
N/A | |
Recruiting |
NCT06093490 -
Detecting Absence Seizures Using Hyperventilation and Eye Movement Recordings
|
||
Completed |
NCT05675254 -
The Prevalence and Risk Factors of Coagulopathy in Pediatric Epilepsy Surgery Patients
|
||
Recruiting |
NCT05740423 -
Standardization of Anti-Seizure Medications Withdrawals After Seizure Remission in Young Patients With Epilepsy
|