COVID-19NCT05205590
COVID-19 Pandemic and Migraine Disorder, Tension Headache and Epilepsy
An observational study of COVID-19, run by Aswan University at 1 site in Egypt.
Trial summary
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 ). Read more about this study
- Who is it for?
- Ages 1 year to 20 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Non
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients presented to the Neuro-psychiatry outpatient Clinic, Aswan University Hospital
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Coronavirus Disease 2019 (COVID-19) Pandemic on 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.
Read more
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.
Read the detailed description
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
- Conditions
- COVID-19
- Being tested
- Non
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NonOther
Non
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Migraine, Tension Headache and Epilepsy due to COVID-19 pandemic
Frequency
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start1 Jun 2021
- Primary completion1 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aswan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bastawy Al Fawal, Aswan University
- Investigators
- Bastawy M AlFawal, MD, Principal investigator, Aswan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205590
- Sponsor's protocol ID
- IRB: 547/7/21
- Status last verified
- Feb 2024
- First submitted
- 24 Jan 2022
- Last updated
- 22 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Coronavirus Disease 2019 (COVID-19) Pandemic on Migraine Disorder, Tension Headache and Epilepsy
- ClinicalTrials.gov ID
- NCT05205590
- Acronym / sponsor ID
- IRB: 547/7/21
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Aswan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 year to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients presented to the Neuro-psychiatry outpatient Clinic, Aswan University Hospital
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- Age below 20years.
- Acute infarction or hemorrhage.
- Inability to respond to questionnaires.
- Severe medical illness.
- Drug or alcohol abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NonNon | Other | – |
Primary outcome
Change in Migraine, Tension Headache and Epilepsy due to COVID-19 pandemic
Time frame: 8 months
Frequency
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bastawy M AlFawal, MD principal investigator
Aswan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Aswan University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Migraine, Tension Headache and Epilepsy due to COVID-19 pandemic (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.