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Completed

NCT Number: NCT05235776

New-onset Severe Headache After Covid-19 Vaccine

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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Key information

Conditions

Headache Brain Diseases COVID-19 Central Nervous System Diseases Coronaviridae Infections Coronavirus Infections Headache Disorders Headache Disorders, Primary Infections Lung Diseases Migraine Migraine Disorders Nervous System Diseases Neurologic Manifestations Nidovirales Infections Pain Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hodepineklinikkken Bergen, Bergen, Norway

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About this study

Study Design: Prospective observational multi-center study

Cohort study of patients with new-onset severe headache after Covid-19 vaccine. Patients referred to the participating headache clinics for severe headache after Covid vaccine will be invited to participate in the study. The invitation will be given in conjunction with their visit to the headache specialist. Patients already diagnosed and treated for severe headache after Covid vaccine will be invited to participate during control visits at the participating centres. After written informed consent information information from the initial phases will be collected retrospectively from the medical records of the patients that have already been diagnosed and started with treatment. Further information will be collected prospectively. For newly diagnosed patients all information will be collected prospectively. Blood samples will be drawn to assess immunological mechanisms.

Inclusion criteria

  • Patients aged ≥ 18 years with new onset severe headache or severe worsening of pre-existing headache within one week after Covid vaccination and has not resolved within 3 weeks.
  • Inclusion within 12 months after symptom onset.
  • Informed written consent signed by the patient.

Exclusion criteria

  • Patients not available for follow-up assessments (e.g. non-resident).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

IInclusion criteria:

  • Patients aged ≥ 18 years with new onset severe headache or severe worsening of pre-existing headache within one week after Covid vaccination and has not resolved within 3 weeks.
  • Inclusion within 12 months after symptom onset.
  • Informed written consent signed by the patient.

Exclusion criteria

  • Patients not available for follow-up assessments (e.g. non-resident).

Treatment and study plan

observation

Other

observation

Primary outcomes

  1. Characteristics of the of new onset headache after Covid vaccination

    Time frame: at inclusion

    qualitative description

  2. Characteristics of the of new onset headache after Covid vaccination

    Time frame: 6 months

    qualitative description

Secondary outcomes

  1. Days with headache ((defined by headache intensity > 0 and/ patient's acute headache medication)

    Time frame: at inclusion

    number of days

  2. Days with headache ((defined by headache intensity > 0 and/ patient's acute headache medication)

    Time frame: at 6 months

    number of days

  3. Headache intensity (0-3 scale) on days with headache at baseline

    Time frame: at inclusion

    Headache intensity, number

  4. Duration of new onset headache after Covid vaccination at baseline

    Time frame: at inclusion

    number of hours

  5. Duration of new onset headache after Covid vaccination at 6 months follow-up

    Time frame: at 6 months

    number of hours

  6. The six item Headache Impact Test (HIT-6) score at baseline

    Time frame: at inclusion

    HIT-6 score

  7. The six item Headache Impact Test (HIT-6) score at 6 months follow-up

    Time frame: at 6 months

    HIT-6 score

  8. The rate of brain MRI pathology at baseline

    Time frame: at inclusion

    description of MRI pathology

  9. The change of brain 18F-FDG PET/CT metabolism

    Time frame: 6 months

    description of brain 18F-FDG PET/CT metabolism

  10. The levels of brain specific biomarkers

    Time frame: at inclusion

    The levels of brain specific biomarkers

  11. The level of blood specific biomarkers

    Time frame: at 6 months

    The levels of brain specific biomarkers

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Hodepineklinikken Bergen
  • Medi3
  • Molde Hospital
  • Namsos Hospital
  • Oslo Hodepinesenter
  • Sandvika Nevrosenter
  • St. Olavs Hospital
  • University Hospital, Akershus
  • Vestre Viken Hospital Trust

Registry information

Acronym: CovaxHEAD

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 11, 2022
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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