Natural History and Prognosis of Pediatric Epilepsies With Different Etiology
2026年5月11日 更新者:Battaglia Domenica Immacolata、Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Natural History and Prognosis of Pediatric Epilepsies With Different Etiology: Long-term Study
Epilepsy is one of the most common neurological diseases in Italy, affecting about 500,000 people. Pediatric age represents one of the most affected groups with a consequent significant impact on the quality of life of the families involved.
The study aims to monitor the cognitive functions of patients followed at our center in order to determine the main types of pathways and highlight their determinants. The ultimate goal is to define what are the main clinical and instrumental predictors of cognitive function and its variation over time.
研究概览
地位
招聘中
研究类型
观察性的
注册 (估计的)
2300
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:domenica Immacolata Battaglia, MD
- 电话号码:+39 0630159222
- 邮箱:domenicaimmacolata.battaglia@policlinicogemelli.it
研究联系人备份
- 姓名:Michela Quintiliani, MD
- 电话号码:+39 0630159222
- 邮箱:michela.quintiliani@guest.policlinicogemelli.it
学习地点
-
-
-
Rome、意大利、00168
- 招聘中
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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接触:
- domenica Immacolata Battaglia, MD
- 电话号码:+39 0630159222
- 邮箱:domenicaimmacolata.battaglia@policlinicogemelli.it
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
接受健康志愿者
不
取样方法
概率样本
研究人群
People with epilepsy seen at the Children's Neuropsychiatry of the Fondazione Policlinico Gemelli IRCCS (UOS Diagnosis and Treatment of Drug-Resistant Epilepsies, Day Hospital or inpatient setting at the Department of Children's Neuropsychiatry).
Epilepsy is defined according to 2014 ILAE criteria: (1) at least two unprovoked (or reflex) seizures occurring more than 24 h apart; (2) one unprovoked (or reflex) seizure and a probability of further seizures similar to the general recurrence risk (at least 60%) after two unprovoked seizures, occurring over the next 10 years; (3) diagnosis of an epilepsy syndrome.
描述
Inclusion Criteria:
- Patients seen at the Children's Neuropsychiatry of the Fondazione Policlinico Gemelli IRCCS (UOS Diagnosis and Treatment of Drug-Resistant Epilepsies, Day Hospital or inpatient setting at the Department of Children's Neuropsychiatry) with onset of first seizure between the ages of 0 and 18 years and subsequent diagnostic confirmation of epilepsy (2 or more unprovoked seizures at least 24 hours apart or definite epilepsy syndrome, with diagnostic confirmation by the child neuropsychiatrist).
- Patients already followed at Child Neuropsychiatry with a diagnosis of epilepsy with age of onset between 0 and 18 years.
- Patients referred to our Center during follow-up with a diagnosis of epilepsy with age of onset between 0 and 18 years.
Exclusion Criteria:
- Patients with unconfirmed diagnosis of epilepsy after the first critical episode.
- Patients from other Centers, for whom the history, clinical and instrumental data are not sufficiently detailed and in accordance with the methodologies followed at our Center.
- Patients with follow-up < 2 years.
- Patients for whom study consent is not provided.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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neurodevelopment level
大体时间:12 months after entry visit
|
Evaluate prescholar global development and scholar cognitive level with Griffiths or Weschler scales where applicable according to age.
|
12 months after entry visit
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Seizure outcome
大体时间:24 months after entry visit
|
Evaluate the reduction in seizures (percentage)
|
24 months after entry visit
|
|
QOLIE-31
大体时间:24 months after entry visit
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Evaluate the Impact of the Epilepsy on the quality of life
|
24 months after entry visit
|
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Clinical Global Impression Scale
大体时间:24 months after entry visit
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Evaluate the global clinical impression to have a measure of epilepsy severity and the burden of antiseizure medication on daily life.
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24 months after entry visit
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Domenica Immacolata Battaglia、Fondazione Policlinico Universitario Agostino Gemelli IRCCS
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年10月26日
初级完成 (估计的)
2027年1月1日
研究完成 (估计的)
2027年6月1日
研究注册日期
首次提交
2023年3月2日
首先提交符合 QC 标准的
2026年5月11日
首次发布 (实际的)
2026年5月15日
研究记录更新
最后更新发布 (实际的)
2026年5月15日
上次提交的符合 QC 标准的更新
2026年5月11日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他研究编号
- 3971
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.