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

Brief summary (registry, in English)

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.

What you commit to

• Study type: Observational
• Planned participants: 100
• From 9 Dec 2025 to the primary completion date, 31 Jul 2027
• 2 sites in 1 country
• Visits and tests: ask the trial team, the registry does not list them

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Who cannot take part

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Who the study is looking for

Age in the registry: 10 years to 18 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

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