Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06353620 |
| Other study ID # |
1018 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 13, 2024 |
| Est. completion date |
February 28, 2027 |
Study information
| Verified date |
April 2024 |
| Source |
IRCCS Eugenio Medea |
| Contact |
Gian Marco Duma, PhD |
| Phone |
+39 0438414248 |
| Email |
gianmarco.duma[@]lanostrafamiglia.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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 drug/surgical treatment. In addition, the aperiodic
portion of the signal may represent a noninvasive measure of the excitation/inhibition
relationship, which is known of being altered both in epilepsy and in some rare
neurodevelopmental syndromes (example: Angelman and Dup15q)
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 process.In particular, the reorganization of the functional connectome following
pharmacological and/or 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 and/or surgical), total freedom or a significant reduction of seizures. In
parallel, the relationship between the organization of functional networks and
cognitive/behavioral 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 child/person. 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.
