New-onset Severe Headache After Covid-19 Vaccine

Brief summary (registry, in English)

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

What you commit to

• Study type: Observational
• Participants enrolled: 63
• From 1 Jan 2022 to the primary completion date, 1 Oct 2023
• 10 sites in 1 country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (10)

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