Clinical trial NCT06782074: Idiopathic Generalized Epilepsy Cognitive and Emotional Profile
Official title: Idiopathic Generalized Epilepsy: Cognitive, Emotional, Behavioral Functioning, and Quality of Life
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Epilepsy
Quality of Life
Neuropathology
Emotional Problem
Executive Dysfunction
Lead sponsor: IRCCS National Neurological Institute "C. Mondino" Foundation
Sponsor class: OTHER
Collaborators: name: Buzzi Children's Hospital, Milan, Italy
name: University of Catanzaro, Italy
name: ASST Rhodense, Rho, Milan, Italy
First posted: 2025-01-17
Enrollment: 96
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients attending the participating clinical units during the 2-year study period will be included in the study.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: cognition in patients with IGE throughout standardized tool WISC IV Wechsler Intelligence Scale for Children - Fourth Edition) or WAIS IV Wechsler Adult Intelligence Scale
timeFrame: 1 year
measure: quality of life in patients with IGE throughout standardized questionnaire
timeFrame: 1 year
measure: behavioral profile in patients with IGE throughout standardized questionnaire
timeFrame: 1 year
measure: executive profile of patients with IGE using standardized questionnaire BRIEF 2
timeFrame: 1 year
Secondary outcomes:
measure: correlation between presence of neurodevelopmental comorbilities and quality of life using an ad hoc questionnaire
timeFrame: 1 year
Other outcomes:
measure: correlation between seizure frequency and qol using an ad hoc questionnaire
timeFrame: 1 year
measure: correlation between the use of antiseizure medication and quality of life using a standardized questionnaire
timeFrame: 1 year
Locations:
city: Pavia
country: Italy
facility: Clinical Trial Center
Study officials:
References: