NCT06782074

Idiopathic Generalized Epilepsy Cognitive and Emotional Profile

Idiopathic Generalized Epilepsy: Cognitive, Emotional, Behavioral Functioning, and Quality of Life

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 96 (estimated)
• Sponsor: IRCCS National Neurological Institute "C. Mondino" Foundation · Academic / Other
• Sex: All
• Age: 11 Years – 17 Years
• Healthy volunteers: —

Summary

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

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

• Epilepsy
• Quality of Life
• Neuropathology
• Emotional Problem
• Executive Dysfunction

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2023-06-01
• Primary completion: 2025-01-30
• Completion: 2025-06-30
• First posted: 2025-01-17
• Last updated: 2025-01-17

Locations

1 site across 1 country: Italy