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RECRUITING
NCT07879976

Alexithymia and Emotional Dysregulation in a Cohort of Pediatric Patients With Epilepsy

Sponsor: Istituto Giannina Gaslini

View on ClinicalTrials.gov

Summary

Epilepsy is a neurological condition characterized by recurrent seizures. Children and adolescents with epilepsy may also experience emotional and psychological difficulties, including problems identifying and describing their emotions (alexithymia), difficulties regulating their emotions, anxiety, and depressive symptoms. These difficulties may affect social relationships and quality of life. However, these aspects have not been adequately investigated in children and adolescents with self-limited focal epilepsies (SeLFE) and idiopathic generalized epilepsies (IGE). Purpose: The purpose of this study is to assess alexithymia, emotional dysregulation, anxiety, depressive symptoms, cognitive functioning, empathic abilities, and quality of life in children and adolescents with SeLFE or IGE and compare their results with those of healthy controls. The study aims to identify possible differences in emotional and psychological functioning between participants with epilepsy and healthy participants. Study Design and Population: This is an Italian, multicenter, prospective observational case-control study involving approximately 100 participants aged 10 to 18 years. The study will include 50 children and adolescents diagnosed with SeLFE or IGE and 50 healthy controls. Participants will be recruited at IRCCS Istituto Giannina Gaslini and Azienda Ospedaliero-Universitaria Santi Antonio e Biagio e Cesare Arrigo in Alessandria, Italy. Study Procedures: After informed consent has been obtained from participants and their parents or legal guardians, as applicable, baseline sociodemographic and clinical information will be collected, including current medication use where relevant. Participants will undergo standardized psychological assessments and complete questionnaires evaluating cognitive functioning, alexithymia, empathic abilities, emotional and behavioral difficulties, anxiety, depressive symptoms, and health-related quality of life. Suicidal ideation and behavior will also be assessed in participants older than 12 years using a standardized assessment tool, as specified in the study protocol. Expected Outcomes and Significance: By comparing children and adolescents with epilepsy with healthy controls, the study aims to improve understanding of the emotional and psychological characteristics associated with SeLFE and IGE. The findings may help identify emotional and psychological difficulties in young people with epilepsy and inform future research and clinical approaches to their assessment and care. No experimental treatment is administered as part of this observational study.

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

Key Details

Gender

All

Age Range

10 Years - 18 Years

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2025-12-09

Completion Date

2027-07

Last Updated

2026-10-19

Healthy Volunteers

No

Locations (2)

Azienda Ospedaliera Universitaria di Alessandria Santi Antonio e Biagio e Cesare Arrigo

Alessandria, Italy

IRCCS Giannina Gaslini

Genova, Italy