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临床试验/NCT05068323
NCT05068323Unknown不适用

Impact of Interictal Epileptiform Activity on Some Cognitive Domains in Newly Diagnosed Epileptic Patients

Assiut University1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2021年9月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
98
试验地点
1
主要终点
Evaluate the effect of some High frequency epileptiform discharges measured by HZ on some cognitive domines using electroencephalogram

研究概览

简要总结

Epilepsy is a common health problem worldwide. In general population, studies in developed countries estimated the annual incidence of epilepsy to be~50 per 100,000 and prevalence to be ~8.2 per 1,000. These figures are higher in developing countries in which prevalence of >10 per 1,000 was reported. In Upper Egypt, Assiut Governorate, the prevalence rate was 12.9 per 1,000.

In people with epilepsy there is an associated high rate of cognitive difficulties that compromise educational progress and achievement throughout life. Approximately 1-5% of the population exhibits epileptiform discharges on electroencephalography (EEG). Interictal epileptiform discharges (IEDs), meaning spikes, polyspikes, sharp waves, or spike and slow-wave complexes without observed clinical seizures, are commonly observed in patients with epilepsy.

Epilepsy syndromes manifesting with IEDs are detrimental to cognitive function. Recently, two studies found that frequent IEDs can impair cognitive performance in children. and adult patients. Several studies indicated that IEDs in patients with epilepsy had a disruptive effect on information processing speed with even a low percentage of IEDs (1%).However, it is unclear whether IEDs are associated with disrupted academic performance in patients with idiopathic epilepsy, and the relationship between general cognitive ability and academic performance in those patients has not been clarified.

Understanding how IEDs interfere with neurocognitive outcomes is important ,while the goal of medical and surgical treatments for epilepsy is to achieve seizure-freedom with minimal morbidity, the benefits of IED suppression are more controversial.

详细描述

This study aims to

  1. Evaluate the influence of interictal epileptiform activity per se on some cognitive functions in newly diagnosed patients with epilepsy (before using anti-seizure medications)
  2. Determine different effects among different brain areas (producing epileptiform activity) on specific cognitive domains Type of the study: Case control Study Study Setting: Assiut university hospital -Neuropsychiatry hospital- Out patient clinics.

Study subjects: Will include epilepsy patients that diagnosed according to the International League Against Epilepsy criteria, 2017:

Study tools All patients included in this study will be subjected to: -

  1. History taking including Personal history, history of present illness, therapeutic history, past history and family history
  2. Complete physical examination. 3) Neurological examination. 4) Digital electroencephalography (EEG) for an hour (16 channels). 5) Psychiatric assessment: all subjects included in the study will be asked to perform a series of psychological tests done by expert psychologist to detect cognitive impairment

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
10 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •a) Patients [with age ranges from 10 to 50 years] of both sex. b) Patients with confirmed diagnosis of idiopathic localization-related or generalized epilepsy.
  • •c) Either before receiving anti-epileptic drugs or on regular treatment with antiepileptic drugs for less three months.

排除标准

  • •Patients with symptomatic or secondary epilepsies either due to general medical conditions or drug induced.
  • •Other neurological , psychiatric or metabolic disorders that affect cognition.
  • •Regular use of antiepileptic medications more than three months.
  • •utilization of regular medications other than AEDs that affect cognition.

研究组 & 干预措施

Epilepsy

Other

Newly diagnosed epileptic patients

干预措施: Digital electroencephalography (EEG) for an hour (16 channels) (Diagnostic Test)

Control

Sham Comparator

healthy subjects

干预措施: Digital electroencephalography (EEG) for an hour (16 channels) (Diagnostic Test)

结局指标

主要结局

Evaluate the effect of some High frequency epileptiform discharges measured by HZ on some cognitive domines using electroencephalogram

时间窗: 2 months

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

Shady Mohamed Safwat Hassan

Lecturer of Neurology

Assiut University

研究点 (1)

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