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临床试验/NCT06388174
NCT06388174招募中不适用

Idiopathic Generalized Epilepsy Syndromes: Clinical Features and Long-term Outcomes

Shen Chun-Hong1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
The proportion of seizure freedom

研究概览

简要总结

The idiopathic generalized epilepsies (IGEs) have historically included the syndromes childhood absence epilepsy (CAE), juvenile absence epilepsy (JAE), juvenile myoclonic epilepsy (JME), and epilepsy with generalized tonic-clonic seizures alone (GTCA). Recognition of the IGEs is important for clinical care, as it informs diagnosis, prevents unnecessary investigation, allows optimal selection of anti-seizure medications (ASMs), and provides prognostic guidance.

According to the new ILAE definition in 2022, the study aims to describe the clinical features, electroencephalographic, imaging findings and long-term prognosis.

详细描述

the Long-term prognosis include the rate of drug-resistent epilepsy, relapse after drug withdrawn, common comorbidities such as mood disorders, attention deficit hyperactivity disorder (ADHD) and learning disabilities.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
4 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients are consecutively and prospectively enrolled from epilepsy center, with newly diagnosed epilepsy or established epilepsy.
  • Patients have a diagnosis of idiopathic generalized epilepsy (IGE), according to the 2022 diagnostic criteria.
  • Comprehensive clinical information is collected, and 24 hour video-electroencephalography is performed.
  • Sign the informed consent forms.

排除标准

  • Other epilepsy syndromes are considered during follow-up, such as genetic generalized epilepsy.
  • Lost to follow-up

结局指标

主要结局

The proportion of seizure freedom

时间窗: through study completion, an average of 1 year

We defined seizure freedom according to the International League Against Epilepsy (ILAE) definition

The proportion of drug-resistent epilepsy

时间窗: through study completion, an average of 1 year

We defined drug-resistant cases as those patients who have failed two or more trials of broad-spectrum ASMs or those otherwise indicated in IGE syndromes

次要结局

  • The proportion of psychiatric comorbidity(through study completion, an average of 1 year)
  • The proportion of psychosocial outcome(through study completion, an average of 1 year)
  • The proportion of seizure relapse after antiseizure medication withdrawn(through study completion, an average of 1 year)

研究者

发起方
Shen Chun-Hong
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Shen Chun-Hong

Associate Senior Doctor

Second Affiliated Hospital, School of Medicine, Zhejiang University

研究点 (1)

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