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临床试验/NCT03490487
NCT03490487Unknown4 期

Electroclinical Effect of Steroid in Patients With Benign Childhood Epilepsy With Centrotemporal Spikes

Assiut University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年6月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
100
试验地点
1
主要终点
To detect the effect of oral steroids regarding improvement of cognitive functions of patients with BECTS.

研究概览

简要总结

Benign epilepsy with centro-temporal spikes is the most common type of focal epilepsy in children. It is known to be age-dependent and presumably genetic. Age of onset ranges from one to fourteen years and it represents fifteen percent to twenty five percent of epilepsy in children under 15 years of age.

详细描述

Generally, Benign epilepsy with centro-temporal spikes is characterized by infrequent focal sensorimotor seizures in the face during sleep, which may secondarily generalize, along with spike-wave discharges, reflecting nonlesional cortical excitability from rolandic regions.

The prognosis is usually considered to be excellent. Over the past years, however, some investigators have questioned whether Benign epilepsy with centro-temporal spikes is indeed benign, considering the variety of different presentations associated with the disorder.It is not uncommon for Benign epilepsy with centro-temporal spikes to be associated with neuropsychological deficits, such as linguistic, cognitive, and behavioral impairment. In particular, reading difficulties and speech/language disorders are more common in children with Benign epilepsy with centro-temporal spikes than in healthy controls.Various neuropsychological deficits seem to be very dependent on the spike index, as well as the predominant localization of epileptiform discharges.Furthermore, the frequency of epileptiform discharges is closely related not only to the degree of neuropsychological deficits, but also to an atypical evolution of benign epilepsy with centro-temporal spikes.

The high comorbid prevalence of attention deficit hyperactivity disorder and epilepsy suggests that there is a bidirectional relationship between these disorders .Cognitive impairment and attention problems are particularly crucial issues in children with epilepsy who are in a vigorous phase of neurodevelopment.

Resolution of continuous spike-and-wave during sleep had been achieved with conventional antiepileptic drugs including ethosuximide, valproic acid, levetiracetam, and sulthiame. When these agents fail to normalize the EEG, a trial with second-line agents such as steroids or high-dose diazepam is attempted.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
3 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • History and EEG findings of benign epilepsy with centrotemporal spikes

排除标准

  • Genetic disorders.
  • Metabolic or neurodegenerative disease.
  • Gross motor delay.

研究组 & 干预措施

B steroid

Experimental

will receive oral steroid for 3 months beside conventional antiepileptic drugs

干预措施: conventional antiepileptic drugs (Drug)

A antiepileptic

Active Comparator

will receive conventional antiepileptic drugs only

干预措施: conventional antiepileptic drugs (Drug)

B steroid

Experimental

will receive oral steroid for 3 months beside conventional antiepileptic drugs

干预措施: oral steroid (Drug)

结局指标

主要结局

To detect the effect of oral steroids regarding improvement of cognitive functions of patients with BECTS.

时间窗: 3 months

Intelligence quotient assessment with Stanford-Binet scales will be done before and after three months of treatment with steroid. Stanford-Binet Intelligence Scale (Fourth Edition) score: very superior (140 and above), superior (120-139), high average (110-119), normal average (90-109), low average (80-89), borderline defective (70-79), mentally defective (30-69). Higher scores will be considered a better or outcome.

To detect the effect of oral steroids on normalization of sleep EEG.

时间窗: 3 months

follow up Electroencephalography and calculation of spike-wave index before and after three months of treatment with steroid.Any reduction in spike wave index on electroencephalograph after receiving steroid will be considered improvement.The EEG technicians will be requested to perform a prolonged daytime nap EEG. The researcher first will look at the full sleep recording and visually pick the epoch with the highest spike density. The counting start with a page of a high spike density and continued for 10 consecutive minutes. Each page will be scored separately. Each second which contained spikes, either focal or generalized, will be considered positive, and the total number of positive seconds per page will be calculated as percents of the whole page. At the end of the counting, an average of 60 pages (10 min) will be performed and then displayed in terms of the nearest ten percentile number.

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

Khalaf A Sayed

Principal Investigator

Assiut University

研究点 (1)

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