Structural-functional Connectome in Drug-resistant Epilepsies and Neurodevelopmental Syndromes With Epilepsy

NCT06353620 | Recruiting

• 1 other identifier: 1018
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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 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)

Conditions

Epilepsy; Angelman Syndrome; Dup15q Syndrome

Outcome Measures

Primary Outcomes (3)

• 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.

  2 years

• 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.

  2 years

• 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

  2 years

Study Arms (4)

Epilepsy

EEG resting state recording, neuropsychological evaluation

Diagnostic Test: High Density EEG recording; Diagnostic Test: Rey Complex Figure Test

Angelman Syndrome

EEG resting state recording, neuropsychological evaluation

Diagnostic Test: High Density EEG recording; Diagnostic Test: Rey Complex Figure Test

Dup15q Syndrome

EEG resting state recording, neuropsychological evaluation

Diagnostic Test: High Density EEG recording

Control Group

EEG resting staterecording

Diagnostic Test: High Density EEG recording

Interventions

High Density EEG recording DIAGNOSTIC_TEST

Recording of resting state high density EEG (128 channels)

Angelman Syndrome; Control Group; Dup15q Syndrome; Epilepsy

Rey Complex Figure Test DIAGNOSTIC_TEST

Memeory functioning evaluation

Angelman Syndrome; Epilepsy

Eligibility Criteria

• Age: 6 Years - 75 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of focal or generalized epilepsy, Angelman syndrome, or Dup15q

You may qualify if:

• 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;
• ability to take part in a neuropsychological evaluation.

You may not qualify if:

• 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
• inability to take part in a neuropsychological evaluation.

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead

Study Sites (1)

IRCCS E.Medea

Conegliano, Treviso, 31015, Italy

RECRUITING

MeSH Terms

Conditions

Epilepsy; Angelman Syndrome

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Imprinting Disorders

Study Officials

• Gian Marco Duma

  IRCCS E. Medea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gian Marco Duma, PhD

CONTACT

+39 0438414248; gianmarco.duma@lanostrafamiglia.it

Darling Boachie

CONTACT

+39 0438 41242; segreteriascientifica.medea.veneto@lanostrafamiglia.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: April 9, 2024
• Study Start: February 13, 2024
• Primary Completion: March 18, 2024
• Study Completion (Estimated): February 28, 2027
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)