New-onset Severe Headache After Covid-19 Vaccine
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 10
- 主要终点
- Characteristics of the of new onset headache after Covid vaccination
研究概览
简要总结
Hypotheses:
- Severe new-onset headache after Covid-19 vaccine occur in a minor subset of vaccinated individuals.
- Immunological reactivity with activation of trigeminal nociceptors can be among the mechanisms in severe headaches after Covid-19 vaccines.
- 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:
- Investigate potential mechanisms and analyse biomarkers to predict treatment effects.
- To assess at baseline and 6-month follow-up the rate of brain MRI pathology.
- To assess the change xof brain 18F-FDG PET metabolism from baseline and 6-month follow-up
- To assess the levels of brain specific biomarkers
- 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
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Characteristics of the of new onset headache after Covid vaccination
时间窗: 6 months
qualitative description
次要结局
- The six item Headache Impact Test (HIT-6) score at baseline(at inclusion)
- The six item Headache Impact Test (HIT-6) score at 6 months follow-up(at 6 months)
- The change of brain 18F-FDG PET/CT metabolism(6 months)
- Days with headache ((defined by headache intensity > 0 and/ patient's acute headache medication)(at 6 months)
- The levels of brain specific biomarkers(at inclusion)
- The level of blood specific biomarkers(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)
- The rate of brain MRI pathology at baseline(at inclusion)
研究者
Anne Hege Aamodt
Dr.
Oslo University Hospital