Pain Perception, Headache Provocation and Multiomics of People Who Are Unable to Have Headache
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Transcriptomic changes
研究概览
简要总结
Headaches are extremely common illnesses with a combined lifetime prevalence of 90-99% in Europe. Despite this high prevalence, there are persons who have never, in their whole life, encountered a headache.
The aim of the study is to identify factors that protect against headache by studying multiomics in people who never have had a headache (headache resistant) versus non-resistant controls.
The investigators will measure multiomic changes (transcriptomics and metabolomics) after pain induction by Cold Pressor Test. 3 blood samples, two for RNA and one for metabolites are taken 5 minutes before a Cold Pressor Test and again 1 hour after the Cold Pressor Test.
The investigators hope to contribute with novelty to the current understanding of headache pathophysiology and development of more efficient treatment of headache.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Headache resistant and non-resistant male participants from the Danish Blood Donor Study.
- •Weight: 45 kg to 95 kg
排除标准
- •Daily consumption of any medication.
- •Consumption of any medication less than 12 hours prior to the study day.
- •Headache on the study day or 48 hours prior to the study day.
- •Amnestic or clinical signs of hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg) or hypotension (systolic blood pressure <90 mmHg and/or diastolic blood pressure <50 mmHg).
- •Any severe cardiovascular disease, including cerebrovascular illness.
- •Amnestic or clinical signs of current mental illness.
- •Amnestic or clinical signs of current substance or drug abuse.
- •Amnestic or clinical signs of any illness the responsible doctor considers relevant for participation in the study.
结局指标
主要结局
Transcriptomic changes
时间窗: 1 hour
Difference in RNA expression between cases and controls after Cold Pressor Test.
Metabolomic changes
时间窗: 1 hour
Difference in metabolites between cases and controls after Cold Pressor Test.
次要结局
未报告次要终点
研究者
Isa Amalie Olofsson
Principal Investigator
Danish Headache Center