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

Key facts

Where
Alessandria and Genova, ItalySee the 2 sites

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 10 and 18 years old?

Source: NCT07879976, who can take part

Where in Italy

  • Azienda Ospedaliera Universitaria di Alessandria Santi Antonio e Biagio e Cesare ArrigoAlessandria, ItalyTaking people
  • IRCCS Giannina GasliniGenova, ItalyTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Istituto Giannina Gaslini
Trial code
NCT07879976
Record updated
19 October 2026
Original description
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).Read full original descriptionShow less

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

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.

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

ClinicalTrials.gov NCT07879976