Clinical trial Recruiting at 2 sites Observational Ages 10 to 18

Alexithymia and emotional dysregulation in children with epilepsy

Official title: ALESSITIMIA E DISREGOLAZIONE EMOTIVA IN UNA COORTE DI PAZIENTI EPILETTICI PEDIATRICI //Alexithymia and Emotional Dysregulation in a Cohort of Pediatric Patients With Epilepsy

Run by Istituto Giannina Gaslini · NCT07879976 · Data updated 2026-11-12

This study tests how alexithymia and emotional regulation relate to epilepsy in kids aged 10–18 and compares them with healthy peers.

More Epilepsies trials

Quick facts

Study typeObservational
Ages10 Years to 18 Years
SexAll
Enrollment100 (estimated)
SponsorIstituto Giannina Gaslini
Academic / other
Locations2 sites (Alessandria and 1 other locations)
StatusRecruiting
StartedDecember 9, 2025
Main results expectedJuly 2027
Study endsJuly 2027
Registry record updatedOctober 19, 2026
Trial IDNCT07879976 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are 10–18-year-olds diagnosed with SeLFE or IGE, on stable medication, and with informed consent from a parent or guardian.

Probably not a fit

Participants with intellectual disability, neurodevelopmental comorbidities, structural brain MRI abnormalities, or lack of informed consent may not benefit from the study results.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will evaluate alexithymia, emotional dysregulation, anxiety, depressive symptoms, cognitive functioning, empathic abilities, and quality of life in children and adolescents with self-limited focal epilepsy (SeLFE) or idiopathic generalized epilepsy (IGE). Participants will be 10–18 years old with stable treatment, and results will be compared to healthy controls to identify differences in emotional and psychological functioning. No interventional treatment is described, and the study will rely on neuropsychological assessments and questionnaires. Data from this study may inform how emotional health is addressed in pediatric epilepsy care. The lead institution is Istituto Giannina Gaslini in collaboration with the Alessandria site, with no additional collaborators listed.

Why it matters

Potential benefit: If successful, the study could highlight emotional health targets to improve quality of life for children with epilepsy.

How similar studies have gone: Previous research suggests emotional and cognitive factors can differ in pediatric epilepsy, but direct studies in SeLFE and IGE with matched controls are limited, making this study relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Age between 10 and 18 years.
* Diagnosis of self-limited focal epilepsy (SeLFE) or idiopathic generalized epilepsy (IGE)
* Written informed consent provided by parents or legal guardians.
* Stable pharmacological treatment throughout the neuropsychological assessment period.

Exclusion Criteria:

* Known diagnosis of intellectual disability or borderline cognitive functioning (full-scale IQ \< 85).
* Known comorbidity with a neurodevelopmental disorder.
* Structural abnormalities detected on brain magnetic resonance imaging (MRI).
* Drug-resistant epilepsy (Kwan et al., 2010).
* Absence of informed consent to participate in the study.

Where it's running

  • Azienda Ospedaliera Universitaria di Alessandria Santi Antonio e Biagio e Cesare Arrigo
    Alessandria, Italy
    Recruiting
  • IRCCS Giannina Gaslini
    Genova, Italy
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.