Idiopathic Generalized Epilepsy Cognitive and Emotional Profile

NCT06782074 | Recruiting

• 1 other identifier: IGE
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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

  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).

  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.

  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.)

  1 year

Secondary Outcomes (1)

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

  1 year

Other Outcomes (2)

• correlation between seizure frequency and qol using an ad hoc questionnaire

  1 year

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

  1 year

Interventions

emotional and neuropsychological assessment OTHER

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.

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Age between 11 and 18 years Diagnosis of idiopathic generalized epilepsy

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS National Neurological Institute "C. Mondino" Foundation: lead
• Buzzi Children's Hospital, Milan, Italy: collaborator
• University of Catanzaro, Italy: collaborator
• ASST Rhodense, Rho, Milan, Italy: collaborator

Study Sites (1)

Clinical Trial Center

Pavia, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Epilepsy

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Central Study Contacts

Valentina De Giorgis, MD PhD

CONTACT

+390382380289; valentina.degiorgis@mondino.it

martina paola P. zanaboni, psy

CONTACT

+390382380289; martinapaola.zanaboni@MONDINO.IT

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: January 17, 2025
• Study Start: June 1, 2023
• Primary Completion: January 30, 2025
• Study Completion: June 30, 2025
• Last Updated: January 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)