NCT05205590

Brief 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 ). 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 25, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

1 year

First QC Date

January 24, 2022

Last Update Submit

February 21, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

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

    Frequency

    8 months

Interventions

NonOTHER

Non

Eligibility Criteria

Age1 Year - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Patients presented to the Neuro-psychiatry outpatient Clinic, Aswan University Hospital

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aswan University

Aswān, Egypt

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Bastawy M AlFawal, MD

    Aswan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 24, 2022

First Posted

January 25, 2022

Study Start

June 1, 2021

Primary Completion

June 1, 2022

Study Completion

June 30, 2022

Last Updated

February 22, 2024

Record last verified: 2024-02

Locations