Idiopathic Generalized Epilepsy Cognitive and Emotional Profile

NCT ID: NCT06782074

Last Updated: 2025-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

96 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-01

Study Completion Date

2025-06-30

Brief Summary

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The primary goal of the study is to explore the neurocognitive, emotional-behavioral functioning, and quality of life of adolescents with IGE, identifying key factors that affect their overall well-being.

The study involves participants and their caregivers completing standardized questionnaires. Additionally, clinical and anamnesic information will be collected to investigate the role of these variables on the emotional and executive functioning of the enrolled subjects

Detailed Description

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The 2022 ILAE classification includes several types of idiopathic generalized epilepsy (IGE), including childhood absence epilepsy (CAE), adolescent absence epilepsy (JAE), juvenile myoclonic epilepsy (JME), and generalized tonic-clonic seizure epilepsy (GTCA). While neurocognitive development is generally normal, these conditions are often associated with mood disorders, ADHD, and learning disabilities. Prognostically, patients with IGE tend to experience negative social outcomes such as poor academic performance, increased risk of unintended pregnancies, and psychiatric or emotional problems. These conditions may involve a range of seizure types, including absence, myoclonic, and tonic-clonic seizures, with EEG showing generalized spikes of 2.5-5.5 Hz.

These epilepsy syndromes are typically responsive to medication, but polytherapy is often required for optimal seizure control. The likelihood of remission and the age of remission can vary between syndromes, and patients may transition from one IGE syndrome to another. In recent years, the focus of epilepsy treatment has shifted beyond seizure control to include psychological factors, aiming to improve the patient's overall health-related quality of life (HRQOL). Studies have shown that children with epilepsy have lower HRQOL compared to healthy controls or children with other chronic conditions. Factors influencing HRQOL include psychiatric comorbidities, psychosocial challenges, cognitive and executive functioning, as well as epilepsy-specific variables such as seizure frequency, duration, and medication side effects.

The primary goal of the study is to explore the neurocognitive, emotional-behavioral functioning, and quality of life of adolescents with IGE, identifying key factors that affect their overall well-being.

Conditions

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Epilepsy Quality of Life Neuropathology Emotional Problem Executive Dysfunction

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Interventions

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emotional and neuropsychological assessment

The tests for evaluating emotional-behavioral functioning and quality of life will be self-administered by the patient/caregiver during regular follow-up visits. The cognitive assessment will be conducted by the clinician using standardized tests.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Age between 11 and 18 years Diagnosis of idiopathic generalized epilepsy

Exclusion Criteria

Age under 11 years or over 18 years Structural or cryptogenic epilepsy Intellectual disability or borderline cognitive level Refusal to participate in the study Failure to obtain informed consent
Minimum Eligible Age

11 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Buzzi Children's Hospital, Milan, Italy

UNKNOWN

Sponsor Role collaborator

University of Catanzaro, Italy

UNKNOWN

Sponsor Role collaborator

ASST Rhodense, Rho, Milan, Italy

UNKNOWN

Sponsor Role collaborator

IRCCS National Neurological Institute "C. Mondino" Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinical Trial Center

Pavia, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Valentina De Giorgis, MD PhD

Role: CONTACT

+390382380289 ext. +39

martina paola P. zanaboni, psy

Role: CONTACT

+390382380289 ext. +39

Facility Contacts

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Cinzia Fattore, MD

Role: primary

0382 380385 ext. 0039

Other Identifiers

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IGE

Identifier Type: -

Identifier Source: org_study_id

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