Healthy Clinical Trial
Official title:
Pain Perception, Headache Provocation and Multiomics of People Who Are Unable to Have Headache
Verified date | March 2021 |
Source | Danish Headache Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | March 12, 2020 |
Est. primary completion date | March 12, 2020 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Headache resistant and non-resistant male participants from the Danish Blood Donor Study. - Weight: 45 kg to 95 kg Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Danish Headache Center | Glostrup | Region H |
Lead Sponsor | Collaborator |
---|---|
Danish Headache Center |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Transcriptomic changes | Difference in RNA expression between cases and controls after Cold Pressor Test. | 1 hour | |
Primary | Metabolomic changes | Difference in metabolites between cases and controls after Cold Pressor Test. | 1 hour |
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