Understanding brain connectivity in drug-resistant epilepsy and neurodevelopmental syndromes
Structural-functional Connectome With High-density Electroencephalography in Drug-resistant Epilepsies and Rare Neurodevelopmental Syndromes With Epilepsy
IRCCS Eugenio Medea · NCT06353620
This study is testing how the brain connects in people with drug-resistant epilepsy and certain developmental disorders to see if it can help improve their treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 6 Years to 75 Years |
| Sex | All |
| Sponsor | IRCCS Eugenio Medea (other) |
| Locations | 1 site (Conegliano, Treviso) |
| Trial ID | NCT06353620 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze the structural and functional connectivity of the brain in patients with drug-resistant epilepsy and specific neurodevelopmental syndromes, such as Angelman and Dup15q syndromes. By utilizing high-density electroencephalography (HD-EEG) and structural MRI, the study seeks to identify alterations in brain networks that could inform treatment decisions. The research focuses on the relationship between neuronal activity patterns and brain morphology, particularly in relation to the effectiveness of pharmacological and surgical interventions. The findings may provide valuable insights into the prognosis and management of these conditions.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 6 to 75 with a confirmed diagnosis of focal or generalized epilepsy, Angelman syndrome, or Dup15q syndrome.
Not a fit: Patients with vascular causes or high-grade tumors as the cause of epilepsy, or those unable to participate in neuropsychological evaluations, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved clinical management and treatment outcomes for patients with drug-resistant epilepsy and related neurodevelopmental syndromes.
How similar studies have performed: While the approach of using HD-EEG to study brain connectivity is gaining traction, this specific focus on drug-resistant epilepsy and neurodevelopmental syndromes represents a novel area of investigation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Conegliano, Treviso
- IRCCS E.Medea — Conegliano, Treviso, Italy (RECRUITING)
Study contacts
- Principal investigator: Gian Marco Duma — IRCCS E. Medea
- Study coordinator: Gian Marco Duma, PhD
- Email: gianmarco.duma@lanostrafamiglia.it
- Phone: +39 0438414248
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Epilepsy, Angelman Syndrome, Dup15q Syndrome