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New-onset Severe Headache After Covid-19 Vaccine

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clinicaltrials.gov/study/NCT05235776
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT052357760
Health Conditions in Trial
COVID-19
COVID-19
0
Headache
Headache
0
Migraine
Migraine
0
Trial Recruitment Size
500
Trial Sponsor
Oslo University Hospital
Oslo University Hospital
0
Trial Collaborator
‌
Vestre Viken Hospital Trust
0
Namsos Hospital
Namsos Hospital
0
Clinical Trial Start Date
January 1, 2022
0
Primary Completion Date
October 1, 2023
0
Study Completion Date
December 31, 2023
0
Clinical Trial Study Type
Observational0
Observational Clinical Trial Type
Cohort0
Observational Study Perspective
Prospective0
Participating Facility
Møre og Romsdal Hospital Trust
Møre og Romsdal Hospital Trust
0
Oslo University Hospital
Oslo University Hospital
0
Official Name
New-onset Severe Headache After Covid-19 Vaccine0
Last Updated
February 11, 2022
0
Study summary

Hypotheses: 1. Severe new-onset headache after Covid-19 vaccine occur in a minor subset of vaccinated individuals. 2. Immunological reactivity with activation of trigeminal nociceptors can be among the mechanisms in severe headaches after Covid-19 vaccines. 3. Biomarkers in blood and CSF and imaging findings can be used to assess severe new-onset headache after Covid-19 vaccines. The main aim of the project is to describe the characteristics of severe new-onset headache after Covid vaccine and the treatment effects. Secondary aim: 1. Investigate potential mechanisms and analyse biomarkers to predict treatment effects. 2. To assess at baseline and 6-month follow-up the rate of brain MRI pathology. 3. To assess the change xof brain 18F-FDG PET metabolism from baseline and 6-month follow-up 4. To assess the levels of brain specific biomarkers 5. To assess the level of blood specific biomarkers Duration of Study participation: * Enrollment: 24 months * Follow-up: at 3 and 6 months after inclusion. For those with continued severe headache regular 3-month controls are planned during the study. Total study duration 24 months

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