New-onset Severe Headache After Covid-19 Vaccine

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

Conditions

• Headache
• Migraine
• COVID-19

Interventions

OTHER

observation

observation

Sponsors & Collaborators

• St. Olavs Hospital

  collaborator OTHER

• University Hospital, Akershus

  collaborator OTHER

• Vestre Viken Hospital Trust

  collaborator OTHER

• Hodepineklinikken Bergen

  collaborator UNKNOWN

• Molde Hospital

  collaborator OTHER

• Namsos Hospital

  collaborator OTHER

• Medi3

  collaborator UNKNOWN

• Oslo Hodepinesenter

  collaborator UNKNOWN

• Sandvika Nevrosenter

  collaborator UNKNOWN

• Oslo University Hospital

  lead OTHER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-01

Primary Completion

2023-10-01

Completion

2023-12-31

Countries

• Norway

Study Locations