NCT06353620 Structural-functional Connectome in Drug-resistant Epilepsies and Neurodevelopmental Syndromes With Epilepsy
| NCT ID | NCT06353620 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Eugenio Medea |
| Condition | Epilepsy |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-02-13 |
| Primary Completion | 2024-03-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2024-02-13 with a primary completion date of 2024-03-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Gian Marco Duma
PRINCIPAL INVESTIGATOR
IRCCS E. Medea
Frequently Asked Questions
Who can join the NCT06353620 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 75 Years, studying Epilepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06353620 currently recruiting?
Yes, NCT06353620 is actively recruiting participants. Contact the research team at gianmarco.duma@lanostrafamiglia.it for enrollment information.
Where is the NCT06353620 trial being conducted?
This trial is being conducted at Conegliano, Italy.
Who is sponsoring the NCT06353620 clinical trial?
NCT06353620 is sponsored by IRCCS Eugenio Medea. The principal investigator is Gian Marco Duma at IRCCS E. Medea. The trial plans to enroll 120 participants.
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