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NCT Number: NCT05205590

COVID-19 Pandemic and Migraine Disorder, Tension Headache and Epilepsy

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

1 year–20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Aswan University

Aswān, Egypt

About this study

Aim of the study:

This study aims to:

Explore the possible changes in migraine& tension headache frequency, severity during quarantine period.
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.
Study lifestyle changes, emotions.
Assess quality of life before and after pandemic.

Inclusion criteria

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.

Exclusion criteria

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.

Patient & Method :

This study will be conducted at Aswan University Hospital on patients who will come to the Neuropsychiatry Clinic.

Patients will be asked to answer questionnaires related to their diseases e.g. change in frequency and severity during the lockdown period , compliance to treatment ,difficulty in getting medications, sleep and eating habits disturbance, work and overall worries during pandemic.
Depression & anxiety will be assessed before and after pandemic COVID-19 by Hamilton Anxiety and Hamilton Depression scale.(Arabic version).
Quality of life Questionnaire for epilepsy before and after COVID-19 pandemic.
Quality of life Questionnaire for Migraine before and after COVID-19 pandemic.
Quality of life Questionnaire for Tension headache before and after COVID-19 pandemic.

Study type : it's cross section study.

Sample type calculation:

It was carried out using G*Power 3 software . A calculated minimum sample of 300 patients will be needed to detect an effect size of 0.1 in the mean of Hamilton Depression and Anxiety Scales , with an error probability of 0.05 and 90% power on a two-tailed test.

Statistical analysis:

Data will be processed by the researchers and analyzed using IBM-SPSS 21.0 (IBM- SPSS Inc., Chicago, IL, USA) .

Descriptive statistics: means, standard deviations, and percentages will be calculated ,Test of significances: Chi-Square/Fisher's Exact tests will be used to compare the difference in distribution of frequencies among different groups.Independent t-test analysis will be carried out compare the means of dichotomous data.A significant p-value wasconsidered when it is equal or less than 0.05.

Ethical considerations:

Risk -benefit assessment:There is no risk on the patients included in thestudy
Confidentiality (dealing with data and data dissemination should be confidential):The confidentiality of patient's information willbe maintained throughout the study
The research procedure will be described in detailsto each patient providing the aims and outcomes of the study as described above.The acceptance to participate will be solely voluntary.
Informed consent:An informed consent will be obtained from all the patients,the study will be approved by ethical committee in faculty of medicine Aswan University

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

non

Other

Non

Primary outcomes

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

Time frame: 8 months

Frequency

Sponsors and collaborators

Lead sponsor

Aswan University

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Jan 25, 2022
Registry last updated: Feb 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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