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临床试验/NCT05205590
NCT05205590已完成不适用

The Impact of Coronavirus Disease 2019 (COVID-19) Pandemic on Migraine Disorder, Tension Headache and Epilepsy

Aswan University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Change in Migraine, Tension Headache and Epilepsy due to COVID-19 pandemic

研究概览

简要总结

Coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has already rapidly spread around the world as a pandemic after its first report in Wuhan, China on December 12th 2019 ( Holshue ML et al .,2019 ). As of December 27th 2020, there were more than 79.2 million confirmed cases and more than 1.7 million deaths caused by COVID-19 worldwide (WHO,2020).

Migraine& tension headacheare considered one of the most disabling chronic neurological diseases, and patients with migraine or tension headache are particularly vulnerable to drastic negative impacts of the pandemic. From heightened levels of psychosocial stress, social isolation , disruption of sleep and dietary habits ,to several COVID-19-specific concerns.

Normally, people with epilepsy (PWE)patients are very sensitive to different factors such as physical or emotional disturbances or environmental and lifestyle changes.Many factors can increase the risk of seizures,i.e., illness and fever, stressful events, sleep deprivation,changes in antiepileptic drugs (AED),use of proconvulsive treatments,to name a few.Some are unavoidable during a sociosanitary crisis like that currently being experienced.

Because of the rapid increase of infections, Government enacted a national state of emergency, limiting public mobility and compelling home confinement and social isolation. This national lockdown, in addition to the direct effects of COVID-19, have dramatically altered the lifestyle and normal routines of the entire population.Therefore, in addition to the risk of neurological involvement that COVID-19 itself has, during the pandemic,different circumstances may negatively impact on seizure control in PWE.

详细描述

Aim of the study:

This study aims to:

  1. Explore the possible changes in migraine& tension headache frequency, severity during quarantine period.
  2. Have a better understanding of the influence of the COVID-19 pandemic in people with epilepsy (PWE) and to assess whether there have been changes in seizure control during the current COVID-19 outbreak, exploring the possible causes of that.
  3. Study lifestyle changes, emotions.
  4. Assess quality of life before and after pandemic.

Inclusion criteria :

  1. Patient with migraine (with and without Aura) diagnosed according to the international classification of headache disorders 3rd edition ( ICHD-3)
  2. Patient with Chronic tension-type headache diagnosed according to ( ICHD-3)
  3. Patient with epilepsy diagnosed according to The International League Against Epilepsy (ILAE).
  4. Patients, whether they are infected or not infected with COVID-19.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
1 Year 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with migraine (with and without Aura) diagnosed according to the international classification of headache disorders 3rd edition ( ICHD-3)
  • Patient with Chronic tension-type headache diagnosed according to ( ICHD-3)
  • Patient with epilepsy diagnosed according to The International League Against Epilepsy (ILAE).
  • Patients, whether they are infected or not infected with COVID-19.

排除标准

  • Age below 20years.
  • Acute infarction or hemorrhage.
  • Inability to respond to questionnaires.
  • Severe medical illness.
  • Drug or alcohol abuse.
  • Patient with history of cerebrovascular stroke or TIA ,DM ,addiction, drugs as calcium blockers or beta blockers.

结局指标

主要结局

Change in Migraine, Tension Headache and Epilepsy due to COVID-19 pandemic

时间窗: 8 months

Frequency

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

Bastawy Al Fawal

Associate Professor

Aswan University

研究点 (1)

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