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临床试验/NCT06194422
NCT06194422尚未招募不适用

Psychiatric Comorbidities in Children With Generalized Epilepsy

Assiut University0 个研究点目标入组 62 人开始时间: 2023年12月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
62
主要终点
Psychiatric comorbidities in children with generalized epilepsy

研究概览

简要总结

Epilepsy is defined as a chronic disorder that presents with recurrent episodes of unprovoked seizures. Epileptic seizures are caused by excessive excitation of cortical neurons. The condition has various etiologies and comorbidities.

Classification;

The Classification of Epilepsies includes several diagnostic levels (steps):

  1. from seizure type to epilepsy type (generalized/focal/combined generalized and focal/unknown)
  2. etiology (genetic/ structural/ infectious/ metabolic/ immune/unknown). A clinician can use any level of the classification

详细描述

Epilepsy is defined as a chronic disorder that presents with recurrent episodes of unprovoked seizures. Epileptic seizures are caused by excessive excitation of cortical neurons. The condition has various etiologies and comorbidities Classification

The Classification of Epilepsies includes several diagnostic levels (steps):

  1. from seizure type to epilepsy type (generalized/focal/combined generalized and focal/unknown)
  2. etiology (genetic/ structural/ infectious/ metabolic/ immune/unknown). A clinician can use any level of the classification. Seizures are classified by the onset (focal, generalized or unknown). All types of seizures can be motor or nonmotor.

Focal seizure may evolve to bilateral tonic-clonic (previously called secondary-generalized). Atonic, clonic, tonic, myoclonic seizures and epileptic spasms can be either of focal or generalized onset.

Unclassified type of seizure was introduced. Most common psychiatric manifestations ; Common psychiatric disorders that have been reported among patients with un controlled generalized epilepsy include :

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
6 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients with generalized epilepsy either new or old ,controlled or un controlled .
  • School aged patients (from 6 years to 17 years).
  • Patients on anti epileptic treatment .
  • Patients attending children's neurological unit .

排除标准

  • children with other types of epilepsy .
  • children with cerebral palsy.
  • children with neurodegenerative disease.
  • children with neurometabolic disease.
  • mentally retarded children.

结局指标

主要结局

Psychiatric comorbidities in children with generalized epilepsy

时间窗: baseline

Measuring the prevalence of ADHD and Autism among children suffering from generalized epilepsy .All cases included in the study will be evaluated by: * full history including neurological history . * full examination including neurological examination . * Investigations: * EEG * ADHD Symptom Checklist-4 (ADHD-SC4( \[8\] * Gilliam Autism Rating scale ( GARS) \[9\] Sample size calculation: Based on determining the main outcome variable, the estimated minimum required total sample size is 62 participants . Main outcome variable: to evaluate phsycatric complications among epilitic pediatric patients. based on previous study, (40%) and (11-30%) ADHD and Autisim In epilitic children respectively . \[10-11\] Main statistical test is chi square to detect the difference in percentage of physiatric disorders( ADHD and Autism) in the two groups . Alpha error = 0.05 Power = 0.80 Allocation ratio= 1 One tailed.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Asmaa Gamal Hashem

resident doctor

Assiut University

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