New-onset Severe Headache After Covid-19 Vaccine

COVID-19 Clinical Trial

— CovaxHEAD  

Official title:

New-onset Severe Headache After Covid-19 Vaccine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05235776
• Other study ID #: 351097
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2022
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• COVID-19
• Headache
• Migraine

Intervention

Other:
• observation
observation

Locations

Country	Name	City	State
Norway	Medi3	Ålesund
Norway	Hodepineklinikkken Bergen	Bergen
Norway	Anub Mathew Thomas	Drammen
Norway	Helsa Fonna Trust	Haugesund
Norway	Møre og Romsdal Hospital Trust	Molde
Norway	Kristina Devik	Namsos
Norway	Oslo University Hospital	Oslo
Norway	Hodeverket	Sandnes
Norway	Sandvika Nevrosenter	Sandvika
Norway	St Olav University Hospital	Trondheim

Sponsors (10)

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

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characteristics of the of new onset headache after Covid vaccination	qualitative description	at inclusion
Primary	Characteristics of the of new onset headache after Covid vaccination	qualitative description	6 months
Secondary	Days with headache ((defined by headache intensity > 0 and/ patient's acute headache medication)	number of days	at inclusion
Secondary	Days with headache ((defined by headache intensity > 0 and/ patient's acute headache medication)	number of days	at 6 months
Secondary	Headache intensity (0-3 scale) on days with headache at baseline	Headache intensity, number	at inclusion
Secondary	Duration of new onset headache after Covid vaccination at baseline	number of hours	at inclusion
Secondary	Duration of new onset headache after Covid vaccination at 6 months follow-up	number of hours	at 6 months
Secondary	The six item Headache Impact Test (HIT-6) score at baseline	HIT-6 score	at inclusion
Secondary	The six item Headache Impact Test (HIT-6) score at 6 months follow-up	HIT-6 score	at 6 months
Secondary	The rate of brain MRI pathology at baseline	description of MRI pathology	at inclusion
Secondary	The change of brain 18F-FDG PET/CT metabolism	description of brain 18F-FDG PET/CT metabolism	6 months
Secondary	The levels of brain specific biomarkers	The levels of brain specific biomarkers	at inclusion
Secondary	The level of blood specific biomarkers	The levels of brain specific biomarkers	at 6 months