New-onset Severe Headache After Covid-19 Vaccine

NCT05235776 | Completed

• 1 other identifier: 351097
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 10

Brief Summary

Hypotheses:

• 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

Outcome Measures

Primary Outcomes (2)

• Characteristics of the of new onset headache after Covid vaccination

  qualitative description

  at inclusion

• Characteristics of the of new onset headache after Covid vaccination

  qualitative description

  6 months

Secondary Outcomes (11)

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

  at inclusion

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

  at 6 months

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

  at inclusion

• Duration of new onset headache after Covid vaccination at baseline

  at inclusion

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

  at 6 months

Interventions

observation OTHER

observation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.
• Informed written consent signed by the patient.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (10)

Medi3

Ålesund, Norway

Location

Hodepineklinikkken Bergen

Bergen, Norway

Location

Anub Mathew Thomas

Drammen, Norway

Location

Helsa Fonna Trust

Haugesund, Norway

Location

Møre og Romsdal Hospital Trust

Molde, Norway

Location

Kristina Devik

Namsos, Norway

Location

Oslo University Hospital

Oslo, 0424, Norway

Location

Hodeverket

Sandnes, Norway

Location

Sandvika Nevrosenter

Sandvika, Norway

Location

St Olav University Hospital

Trondheim, Norway

Location

Related Publications (1)

• Aamodt AH, Ueland T, Boldingh M, Bezgal BE, Argren MB, Dunne CA, Otterdal K, Gregersen I, Bjerkeli V, Michelsen AE, Husoy A, Morsund AH, Devik K, Poole AC, Gjendemsjo KB, Schluter K, Mathisen SM, Aalstad-Johansen M, Skattor TH, Sonnervik J, Boye TB, Popperud TH, Hogestol EA, Harbo HF, Lund-Johansen F, Aukrust P, Tronvik E, Dahl TB, Halvorsen BE. Altered amyloid plasma profile in patients with disabling headaches after SARS-CoV-2 infection and vaccination. BMJ Neurol Open. 2025 Aug 26;7(2):e001013. doi: 10.1136/bmjno-2024-001013. eCollection 2025.

  PMID: 40881041 DERIVED

MeSH Terms

Conditions

Headache; Migraine Disorders; COVID-19

Interventions

Observation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 11, 2022
• Study Start: January 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: December 31, 2023
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

NO (10)