An observational study in Headache, Migraine and COVID-19, sponsored by Oslo University Hospital. Completed at 10 sites in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by Oslo University Hospital · Observational
Hypotheses:
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:
Duration of Study participation:
Total study duration 24 months
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:
Exclusion criteria:
7,638 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 63 is below the median of 260 across 3,135 observational studies indexed under COVID-19.
Browse COVID-19 studies →Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
IInclusion criteria:
Exclusion criteria:
observation
Characteristics of the of new onset headache after Covid vaccination
qualitative description
Time frame: at inclusion
Characteristics of the of new onset headache after Covid vaccination
qualitative description
Time frame: 6 months
Days with headache ((defined by headache intensity > 0 and/ patient's acute headache medication)
number of days
Time frame: at inclusion
Days with headache ((defined by headache intensity > 0 and/ patient's acute headache medication)
number of days
Time frame: at 6 months
Headache intensity (0-3 scale) on days with headache at baseline
Headache intensity, number
Time frame: at inclusion
Duration of new onset headache after Covid vaccination at baseline
number of hours
Time frame: at inclusion
Duration of new onset headache after Covid vaccination at 6 months follow-up
number of hours
Time frame: at 6 months
The six item Headache Impact Test (HIT-6) score at baseline
HIT-6 score
Time frame: at inclusion
The six item Headache Impact Test (HIT-6) score at 6 months follow-up
HIT-6 score
Time frame: at 6 months
The rate of brain MRI pathology at baseline
description of MRI pathology
Time frame: at inclusion
The change of brain 18F-FDG PET/CT metabolism
description of brain 18F-FDG PET/CT metabolism
Time frame: 6 months
The levels of brain specific biomarkers
The levels of brain specific biomarkers
Time frame: at inclusion
The level of blood specific biomarkers
The levels of brain specific biomarkers
Time frame: at 6 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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Oslo University Hospital