Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06271785
Status:
RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-02-14
Brief Title:
Prognostic Value of High-resolution Electrical Source Imaging on the Success of Pediatric Focal Epilepsy Surgery
Sponsor:
University Hospital Angers
Organization:
University Hospital Angers
Study Overview
Official Title:
ISEPEE Prognostic Value of High-resolution Electrical Source Imaging on the Success of Pediatric Focal Epilepsy Surgery
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ISEPEE
Brief Summary:
This study investigates the usefulness of high resolution electrical source imaging HR-ESI in the setting of presurgical evaluation of drug-resistant focal epilepsy in children
This method is based on an estimation of the intra-cerebral source that produces a signal recorded by scalp electrodes by solving the inverse problem taking into account attenuation factors resulting from particular conductivity properties of the cerebral peri-cerebral and cranial tissues
Electrical sources are then fused on structural magnetic resonance imaging MRI
Scalp EEG recorded using 64 to 256 electrodes refers to as high resolution EEG HR-EEG leading to HR-ESI
Studies based on small population of children or on mixt population of children and adults showed that HR-ESI has accuracy values ie percentage of true positives electrical source localized in the brain area resected and success of surgery and true negatives electrical source localized outside the brain area resected and failure of surgery among the total population ranging from 50 to 80
Discrepancies between studies could be explained by the limited number of patients included or by the mixture of pediatric and adult data
Another limitation of previously published studies is that the spatial pattern of dipole source distribution was not taken into account to determine prediction accuracy of ESI
Studies using magnetoencephalography MEG to perform magnetic source imaging MSI suggest that the spatial pattern of dipole source distribution needs to be considered a spatially-restricted dipole distribution being associated with better post-surgical outcome when resected
To tackle these issues the investigators aim to conduct the first large prospective multicentric study in children with focal epilepsy candidates to surgery to assess prediction accuracy of ESI based on the finding of tight clusters of dipoles
This is original as this pattern tight versus loose cluster of dipoles has been studied by several researchers using MEG but not using HR-EEG
The investigators make the hypothesis that HR-EEG will allow to identity good candidates for epilepsy surgery and thus to offer this underutilized treatment in more children with better post-surgical outcome
Among the secondary objectives the investigators will address methodological issues related to the resolution of the inverse problem methods using distributed sources models versus methods based on equivalent dipole estimation the potential added value to model high-frequency oscillations HFO and the investigators will assess the cost-utility of the HR-ESI procedure
This method is based on an estimation of the intra-cerebral source that produces a signal recorded by scalp electrodes by solving the inverse problem taking into account attenuation factors resulting from particular conductivity properties of the cerebral peri-cerebral and cranial tissues
Electrical sources are then fused on structural magnetic resonance imaging MRI
Scalp EEG recorded using 64 to 256 electrodes refers to as high resolution EEG HR-EEG leading to HR-ESI
Studies based on small population of children or on mixt population of children and adults showed that HR-ESI has accuracy values ie percentage of true positives electrical source localized in the brain area resected and success of surgery and true negatives electrical source localized outside the brain area resected and failure of surgery among the total population ranging from 50 to 80
Discrepancies between studies could be explained by the limited number of patients included or by the mixture of pediatric and adult data
Another limitation of previously published studies is that the spatial pattern of dipole source distribution was not taken into account to determine prediction accuracy of ESI
Studies using magnetoencephalography MEG to perform magnetic source imaging MSI suggest that the spatial pattern of dipole source distribution needs to be considered a spatially-restricted dipole distribution being associated with better post-surgical outcome when resected
To tackle these issues the investigators aim to conduct the first large prospective multicentric study in children with focal epilepsy candidates to surgery to assess prediction accuracy of ESI based on the finding of tight clusters of dipoles
This is original as this pattern tight versus loose cluster of dipoles has been studied by several researchers using MEG but not using HR-EEG
The investigators make the hypothesis that HR-EEG will allow to identity good candidates for epilepsy surgery and thus to offer this underutilized treatment in more children with better post-surgical outcome
Among the secondary objectives the investigators will address methodological issues related to the resolution of the inverse problem methods using distributed sources models versus methods based on equivalent dipole estimation the potential added value to model high-frequency oscillations HFO and the investigators will assess the cost-utility of the HR-ESI procedure
Detailed Description:
This study investigates the usefulness of high resolution electrical source imaging HR-ESI in the setting of presurgical evaluation of drug-resistant focal epilepsy in children
This method is based on an estimation of the intra-cerebral source that produces a signal recorded by scalp electrodes by solving the inverse problem taking into account attenuation factors resulting from particular conductivity properties of the cerebral peri-cerebral and cranial tissues
Electrical sources are then fused on structural magnetic resonance imaging MRI
Scalp EEG recorded using 64 to 256 electrodes refers to as high resolution EEG HR-EEG leading to HR-ESI
Studies based on small population of children or on mixt population of children and adults showed that HR-ESI has accuracy values ie percentage of true positives electrical source localized in the brain area resected and success of surgery and true negatives electrical source localized outside the brain area resected and failure of surgery among the total population ranging from 50 to 80
Discrepancies between studies could be explained by the limited number of patients included or by the mixture of pediatric and adult data
Another limitation of previously published studies is that the spatial pattern of dipole source distribution was not taken into account to determine prediction accuracy of ESI
Studies using magnetoencephalography MEG to perform magnetic source imaging MSI suggest that the spatial pattern of dipole source distribution needs to be considered a spatially-restricted dipole distribution being associated with better post-surgical outcome when resected
To tackle these issues the investigators aim to conduct the first large prospective multicentric study in children with focal epilepsy candidates to surgery to assess prediction accuracy of ESI based on the finding of tight clusters of dipoles
This is original as this pattern tight versus loose cluster of dipoles has been studied by several researchers using MEG but not using HR-EEG
The investigators make the hypothesis that HR-EEG will allow to identity good candidates for epilepsy surgery and thus to offer this underutilized treatment in more children with better post-surgical outcome
Among the secondary objectives the investigators will address methodological issues related to the resolution of the inverse problem methods using distributed sources models versus methods based on equivalent dipole estimation the potential added value to model high-frequency oscillations HFO and the investigators will assess the cost-utility of the HR-ESI procedure
The study focuses on epileptic children who are candidates to a procedure of epilepsy surgery aiming to make them seizure-free The principle of epilepsy surgery is to remove the brain area that generates patients seizures ie the seizure onset zone SOZ Candidates are patients with focal seizures that do not completely respond to the medical treatment and impact their quality of life This represents 5-10 of epileptic children Pre-surgical evaluation of these patients consists to perform in a first step non-invasive methods aimed to localize the SOZ video-EEG in order to characterize usual seizures of the patient and to record and localize interictal epileptiform discharges IED MRI to search for a structural epileptogenic lesion and positron emission tomography PET with fluorodeoxyglucose FDG to search for a brain area showing abnormal FDG uptake After this so-called phase 1 work-up the case is discussed in a multidisciplinary meeting resulting in one of the 3 following decisions 1 surgical resection when information from phase 1 is considered as sufficient 2 continuation of the surgical process by performing a phase 2 evaluation ie an invasive EEG recording using intracranial electrodes implanted by stereotaxy SEEG when information from phase 1 is considered as insufficient but made possible to pose a hypothesis regarding the localization of the SOZ and 3 rejection for surgery In children epilepsy makes patient seizure-free in 60-80 of the cases HR-ESI is a relatively new method that has been developed to localize non-invasively the SOZ with the hope to decrease the number of patients rejected for surgery or oriented to phase 2 and to increase the rate of success of epilepsy surgery
This method is based on an estimation of the intra-cerebral source that produces a signal recorded by scalp electrodes by solving the inverse problem taking into account attenuation factors resulting from particular conductivity properties of the cerebral peri-cerebral and cranial tissues
Electrical sources are then fused on structural magnetic resonance imaging MRI
Scalp EEG recorded using 64 to 256 electrodes refers to as high resolution EEG HR-EEG leading to HR-ESI
Studies based on small population of children or on mixt population of children and adults showed that HR-ESI has accuracy values ie percentage of true positives electrical source localized in the brain area resected and success of surgery and true negatives electrical source localized outside the brain area resected and failure of surgery among the total population ranging from 50 to 80
Discrepancies between studies could be explained by the limited number of patients included or by the mixture of pediatric and adult data
Another limitation of previously published studies is that the spatial pattern of dipole source distribution was not taken into account to determine prediction accuracy of ESI
Studies using magnetoencephalography MEG to perform magnetic source imaging MSI suggest that the spatial pattern of dipole source distribution needs to be considered a spatially-restricted dipole distribution being associated with better post-surgical outcome when resected
To tackle these issues the investigators aim to conduct the first large prospective multicentric study in children with focal epilepsy candidates to surgery to assess prediction accuracy of ESI based on the finding of tight clusters of dipoles
This is original as this pattern tight versus loose cluster of dipoles has been studied by several researchers using MEG but not using HR-EEG
The investigators make the hypothesis that HR-EEG will allow to identity good candidates for epilepsy surgery and thus to offer this underutilized treatment in more children with better post-surgical outcome
Among the secondary objectives the investigators will address methodological issues related to the resolution of the inverse problem methods using distributed sources models versus methods based on equivalent dipole estimation the potential added value to model high-frequency oscillations HFO and the investigators will assess the cost-utility of the HR-ESI procedure
The study focuses on epileptic children who are candidates to a procedure of epilepsy surgery aiming to make them seizure-free The principle of epilepsy surgery is to remove the brain area that generates patients seizures ie the seizure onset zone SOZ Candidates are patients with focal seizures that do not completely respond to the medical treatment and impact their quality of life This represents 5-10 of epileptic children Pre-surgical evaluation of these patients consists to perform in a first step non-invasive methods aimed to localize the SOZ video-EEG in order to characterize usual seizures of the patient and to record and localize interictal epileptiform discharges IED MRI to search for a structural epileptogenic lesion and positron emission tomography PET with fluorodeoxyglucose FDG to search for a brain area showing abnormal FDG uptake After this so-called phase 1 work-up the case is discussed in a multidisciplinary meeting resulting in one of the 3 following decisions 1 surgical resection when information from phase 1 is considered as sufficient 2 continuation of the surgical process by performing a phase 2 evaluation ie an invasive EEG recording using intracranial electrodes implanted by stereotaxy SEEG when information from phase 1 is considered as insufficient but made possible to pose a hypothesis regarding the localization of the SOZ and 3 rejection for surgery In children epilepsy makes patient seizure-free in 60-80 of the cases HR-ESI is a relatively new method that has been developed to localize non-invasively the SOZ with the hope to decrease the number of patients rejected for surgery or oriented to phase 2 and to increase the rate of success of epilepsy surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None