Idiopathic Generalized Epilepsy Cognitive and Emotional Profile

ConditionsEpilepsy Quality of Life Neuropathology Emotional Problem Executive Dysfunction

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age11-17

SponsorIRCCS National Neurological Institute "C. Mondino" Foundation

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

All patients attending the participating clinical units during the 2-year study period will be included in the study.

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

emotional and neuropsychological assessment
Other intervention
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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

cognition in patients with IGE throughout standardized tool WISC IV Wechsler Intelligence Scale for Children - Fourth Edition) or WAIS IV Wechsler Adult Intelligence Scale

The study includes the administration of standardized tool (WISC IV or WAIS IV) to describe the cognitive profile of these patients . Minimum score 40 max 160, average score 100, higher scores mean a better performance

Time frame

1 year

quality of life in patients with IGE throughout standardized questionnaire

The study wants to describe quality of life in patients with IGE using standardized questionaire Pediatric Quality of Life Inventory (PedsQL)epilepsy module (min score 0, max 100; higher scores reflect a better quality of life).

Time frame

1 year

behavioral profile in patients with IGE throughout standardized questionnaire

The study aims to define the behavioral profile of patients with IGE using standardized questionnaire: Child Behavior Checklist CBCL (min 0 max 200 higher score worse emotional profile) ,SAFA Strumenti di Autovalutazione per Fanciulli e Adolescenti (Self-Assessment Tools for Children and Adolescents (score min 0 max 100 Higher scores indicate greater emotional or behavioral difficulties.

Time frame

1 year

executive profile of patients with IGE using standardized questionnaire BRIEF 2

The study aims to define the executive profile of patients with IGE using standardized questionnaire Behavior Rating Inventory of Executive Function, Second Edition BRIEF 2 (score min 0 max 160 Higher scores indicate greater executive function difficulties.)

Time frame

1 year

Secondary outcomes

correlation between presence of neurodevelopmental comorbilities and quality of life using an ad hoc questionnaire

The secondary objective of this study is to examine the correlation between the presence or absence of neurodevelopmental comorbidities and the quality of life (QoL). To assess the possible presence of these comorbidities, an ad hoc questionnaire will be used, which investigates the presence of potential comorbidities.

Time frame

1 year

Other outcomes

correlation between seizure frequency and qol using an ad hoc questionnaire

The secondary objective of this study is to examine the correlation between the frequency of epileptic seizures and the quality of life (QoL). The annual frequency of seizures will be determined through an ad hoc questionnaire completed by the clinician.

Time frame

1 year

correlation between the use of antiseizure medication and quality of life using a standardized questionnaire

The secondary objective of this study is to examine the correlation between the use of antiepileptic therapy and the quality of life (QoL). The use of antiepileptic therapy will also be assessed as part of the study through an ad hoc questionnaire.

Time frame

1 year