Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06353620
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-03-20
Brief Title:
Structural-functional Connectome in Drug-resistant Epilepsies and Neurodevelopmental Syndromes With Epilepsy
Sponsor:
IRCCS Eugenio Medea
Organization:
IRCCS Eugenio Medea
Study Overview
Official Title:
Structural-functional Connectome With High-density Electroencephalography in Drug-resistant Epilepsies and Rare Neurodevelopmental Syndromes With Epilepsy
Status:
RECRUITING
Status Verified Date:
2024-04
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:
None
Brief Summary:
Recent studies have shown that the aperiodic part of the signal neuronal avalanches of electroencephalography EEG contains important information about the dynamics of neuronal networks Indeed this has helped to identify functionally altered areas in patients with temporal epilepsy by simply using the resting EEG signal Furthermore it has been seen that the propagation of neuronal avalanches VNs correlates with the morphological organization of the cerebral cortex Therefore NAs represent a measure with direct utility for studying functional reorganization pre and post drugsurgical treatment In addition the aperiodic portion of the signal may represent a noninvasive measure of the excitationinhibition relationship which is known of being altered both in epilepsy and in some rare neurodevelopmental syndromes example Angelman and Dup15q
Detailed Description:
Electroencephalography is the tool of choice for the diagnosis of epilepsy Its use is increasing in the clinic especially in its high-density form HD-EEG because it can be used as a neuroimaging tool supporting the process of identifying the epileptogenic network NE and monitoring the evolution of brain connectivity over time in relation to the epileptic processIn particular the reorganization of the functional connectome following pharmacological andor surgical treatment of epilepsy is an aspect that is still little studied but it could represent a useful prognostic factor that can improve the clinical management of the affected person In addition high-density EEG can be applied for the purpose of characterizing functional brain connectivity in some rare neurodevelopmental diseases particularly Angelman syndrome and Dup15q syndrome pathological increasingly being studied as a model of neurodevelopmental cognitive and behavioral alterations in addition to epilepsy Relatively to recent developments of potentially disease modifying therapies for these pathologies there is indeed a need for markers of brain functioning useful to objectively monitor clinical development
The present study involves the systematization of data from noninvasive clinical-instrumental assessments such as EEG and structural MRI acquired during the diagnosis process in drug-resistant epilepsies and rare neurodevelopmental syndromes associated with epilepsy in order to analyze the relationship between functional-structural organization of the brain system and clinical aspects including cognitive and behavioral functioning In the context of epilepsy a data collection will be carried out to which recent analytical approaches related to the study of the functional connectome will be applied with the aim of characterizing the reorganization of brain networks over time hypothesizing a process of progressive normalization of these in subjects who present after the course of treatment pharmacological andor surgical total freedom or a significant reduction of seizures In parallel the relationship between the organization of functional networks and cognitivebehavioral functioning pre- and post-treatment will be analyzed in order to obtain a dynamic and longitudinal view of the patients clinical evolution With this in mind it is important to understand that functional activity is intrinsically linked to brain structures and in fact the project takes into account the anatomo-functional relationship of the connectome This relationship is crucial in rare neurodevelopmental syndromes such as Angelman syndrome and Dup15q where the use of the structural-functional connectome is a relevant novel element for the purpose of characterizing a highly complex picture that disrupts the global development of the affected childperson Indeed the relationship between changes in functional relationships between brain areas and underlying physical connections as well as the relationship between these and neurodevelopment are still poorly understood The second goal of the project is therefore to generalize the use of these patient-friendly methods starting with data collected with noninvasive instrumentation in order to improve the characterization of the neurocognitive profile as well as a useful tool to identify syndrome-specific biomarkers to be used in monitoring clinical development
The present study involves the systematization of data from noninvasive clinical-instrumental assessments such as EEG and structural MRI acquired during the diagnosis process in drug-resistant epilepsies and rare neurodevelopmental syndromes associated with epilepsy in order to analyze the relationship between functional-structural organization of the brain system and clinical aspects including cognitive and behavioral functioning In the context of epilepsy a data collection will be carried out to which recent analytical approaches related to the study of the functional connectome will be applied with the aim of characterizing the reorganization of brain networks over time hypothesizing a process of progressive normalization of these in subjects who present after the course of treatment pharmacological andor surgical total freedom or a significant reduction of seizures In parallel the relationship between the organization of functional networks and cognitivebehavioral functioning pre- and post-treatment will be analyzed in order to obtain a dynamic and longitudinal view of the patients clinical evolution With this in mind it is important to understand that functional activity is intrinsically linked to brain structures and in fact the project takes into account the anatomo-functional relationship of the connectome This relationship is crucial in rare neurodevelopmental syndromes such as Angelman syndrome and Dup15q where the use of the structural-functional connectome is a relevant novel element for the purpose of characterizing a highly complex picture that disrupts the global development of the affected childperson Indeed the relationship between changes in functional relationships between brain areas and underlying physical connections as well as the relationship between these and neurodevelopment are still poorly understood The second goal of the project is therefore to generalize the use of these patient-friendly methods starting with data collected with noninvasive instrumentation in order to improve the characterization of the neurocognitive profile as well as a useful tool to identify syndrome-specific biomarkers to be used in monitoring clinical development
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?:
False
Is an FDA AA801 Violation?:
None