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临床试验/NCT06782074
NCT06782074招募中不适用

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

IRCCS National Neurological Institute "C. Mondino" Foundation1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
96
试验地点
1
主要终点
cognition in patients with IGE throughout standardized tool WISC IV Wechsler Intelligence Scale for Children - Fourth Edition) or WAIS IV Wechsler Adult Intelligence Scale

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
11 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

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

时间窗: 1 year

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

quality of life in patients with IGE throughout standardized questionnaire

时间窗: 1 year

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).

behavioral profile in patients with IGE throughout standardized questionnaire

时间窗: 1 year

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.

executive profile of patients with IGE using standardized questionnaire BRIEF 2

时间窗: 1 year

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.)

次要结局

  • correlation between presence of neurodevelopmental comorbilities and quality of life using an ad hoc questionnaire(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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