AlexithymiaALEDENCT07879976
Alexithymia and Emotional Dysregulation in a Cohort of Pediatric Patients With Epilepsy
An observational study of Alexithymia and Epilepsies, run by Istituto Giannina Gaslini at 2 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Alexithymia, Epilepsies
- How many people
- 100 participants
- Where
- 2 sitesItaly
- Study dates
- 9 Dec 2025to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: patients from GEnoa and Alessandria 10-18 years epilepsy
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Azienda Ospedaliera Universitaria di Alessandria Santi Antonio e Biagio e Cesare Arrigo
Alessandria
Fabiana Vercellino, MD, +390131 207220, fvercellino@ospedale.al.it
- Recruiting
IRCCS Giannina Gaslini
Genova, 16147
Thea Giacomini, +39 010 56362432, neuropsichiatria@gaslini.org
About this 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
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.
Read more
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.
- Conditions
- Alexithymia, Epilepsies
- Medical subject headings
- Affective Symptoms, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 50 cases and 50 controls | 50 cases and 50 controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at each study visit for 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start9 Dec 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlexithymiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Giannina Gaslini
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879976
- Sponsor's protocol ID
- Alede (14763)
- Acronym
- ALEDE
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07879976
- Acronym / sponsor ID
- ALEDE / Alede (14763)
- Conditions
- Alexithymia, Epilepsies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istituto Giannina GasliniUniversity, hospital or other
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 19 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 50 cases and 50 controls | – | –50 cases and 50 controls |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- patients from GEnoa and Alessandria 10-18 years epilepsy
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
assess alexithymia, emotional dysregulation, anxiety disorders, and depressive symptoms in children with self-limited focal epilepsies
Time frame: at each study visit for 2 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alexithymia and Epilepsies, run by Istituto Giannina Gaslini at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thea Giacomini, MD (+39 010 56362432, neuropsichiatria@gaslini.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess alexithymia, emotional dysregulation, anxiety disorders, and depressive symptoms in children with self-limited focal epilepsies (time frame: at each study visit for 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.