Structural-functional Connectome in Drug-resistant Epilepsies and Neurodevelopmental Syndromes With Epilepsy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-75
SponsorIRCCS Eugenio Medea
About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
a diagnosis of focal or generalized epilepsy, Angelman syndrome, or Dup15q, confirmed by specialist evaluation;
at least one MRI scan of the brain that includes 3D T1 sequences;
at least one 128-channel HD-EEG recording; and
age between 6 and 75 years at the time of the evaluation of the present study;
Disqualifiers
vascular causes or non-low-grade tumors as causes of epilepsy;
age different from the range 6-75 years;
neuroradiological examination not complete (absence T1 3D);
absence of HD-EEG 128-channel recording
Trial population
Patients with a diagnosis of focal or generalized epilepsy, Angelman syndrome, or Dup15q
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
High Density EEG recording
Diagnostic testRecording of resting state high density EEG (128 channels)
Rey Complex Figure Test
Diagnostic testMemeory functioning evaluation
Treatment groups
120 Participants
are divided into 4 treatment groupsGroup A: Epilepsy2 interventions
Group B: Angelman Syndrome2 interventions
Group C: Dup15q Syndrome1 intervention
Group D: Control Group1 intervention
Trial outcomes
Primary outcomes
1
Differences in the network coherence values in theta and alpha band after treatment
The outcome 1 one will be finalized to measures the changes of the coherence values before and after the treatment. Coherence is a measure defining the strength of functional connectivity between two brain regions. The pre- and post-treatment changes will be investigated specifically in the theta and alpha EEG frequency band, since these two bands are the most affected in epilepsy condition.
Time frame
2 years2
Stability of the alpha frequency band in the EEG activity
The detrend fluctuation analysis (DFA) in the alpha band of the EEG power spectrum provides information on excitatory and inihibitory balance of neural activity. For the outcome 2, the exponent of the DFA in the alpha band will be compared between patients with rare neurodevelopmental disorders (Angelman and Dup15q) vs. the healthy control group.
Time frame
2 years3
Correlation of neural excitation and memory performance
Correlation between the aperiodic component of the EEG power specturum with the memory functioning obtained with the Rey Complex Figure Test, pre and post treatment
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov