An observational study in Alexithymia and Epilepsies, sponsored by Istituto Giannina Gaslini. Recruiting at 2 sites in Italy. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Istituto Giannina Gaslini · Observational
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.
84 studies on the registry are indexed under Affective Symptoms; 20 are open to participants now.
This study's planned enrollment of 100 is above the median of 70 across 21 observational studies indexed under Affective Symptoms.
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patients from GEnoa and Alessandria 10-18 years epilepsy
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50 cases and 50 controls
assess alexithymia, emotional dysregulation, anxiety disorders, and depressive symptoms in children with self-limited focal epilepsies
The primary objective of this study is to assess alexithymia, emotional dysregulation, anxiety disorders, and depressive symptoms in children and adolescents with self-limited focal epilepsies (SeLFE) and idiopathic generalized epilepsies (IGE) with onset during childhood or adolescence, and to compare their profiles with those of healthy controls in order to identify potential psychopathological features associated with these epilepsy syndromes.
Time frame: at each study visit for 2 years
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Istituto Giannina Gaslini