Clinical trial NCT05235776: New-onset Severe Headache After Covid-19 Vaccine
Official title: New-onset Severe Headache After Covid-19 Vaccine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Headache
Migraine
COVID-19
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: University Hospital, Akershus
name: Vestre Viken Hospital Trust
name: Hodepineklinikken Bergen
name: Molde Hospital
name: Namsos Hospital
name: Medi3
name: Oslo Hodepinesenter
name: Sandvika Nevrosenter
First posted: 2022-02-11
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief 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

Detailed description: 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).

Eligibility criteria: 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).

Primary outcomes:
measure: Characteristics of the of new onset headache after Covid vaccination
timeFrame: at inclusion
measure: Characteristics of the of new onset headache after Covid vaccination
timeFrame: 6 months
Secondary outcomes:
measure: Days with headache ((defined by headache intensity > 0 and/ patient's acute headache medication)
timeFrame: at inclusion
measure: Days with headache ((defined by headache intensity > 0 and/ patient's acute headache medication)
timeFrame: at 6 months
measure: Headache intensity (0-3 scale) on days with headache at baseline
timeFrame: at inclusion
measure: Duration of new onset headache after Covid vaccination at baseline
timeFrame: at inclusion
measure: Duration of new onset headache after Covid vaccination at 6 months follow-up
timeFrame: at 6 months
measure: The six item Headache Impact Test (HIT-6) score at baseline
timeFrame: at inclusion
measure: The six item Headache Impact Test (HIT-6) score at 6 months follow-up
timeFrame: at 6 months
measure: The rate of brain MRI pathology at baseline
timeFrame: at inclusion
measure: The change of brain 18F-FDG PET/CT metabolism
timeFrame: 6 months
measure: The levels of brain specific biomarkers
timeFrame: at inclusion
measure: The level of blood specific biomarkers
timeFrame: at 6 months
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Hodepineklinikkken Bergen
city: Drammen
country: Norway
facility: Anub Mathew Thomas
city: Haugesund
country: Norway
facility: Helsa Fonna Trust
city: Molde
country: Norway
facility: Møre og Romsdal Hospital Trust
city: Namsos
country: Norway
facility: Kristina Devik
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Sandnes
country: Norway
facility: Hodeverket
city: Sandvika
country: Norway
facility: Sandvika Nevrosenter
city: Trondheim
country: Norway
facility: St Olav University Hospital
city: Ålesund
country: Norway
facility: Medi3
Study officials:
References: