Multiomics After Cold Pressor Test of People Who Are Unable to Have Headache
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|ClinicalTrials.gov Identifier: NCT04220580|
Recruitment Status : Recruiting
First Posted : January 7, 2020
Last Update Posted : January 7, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Headache Headache Disorders Healthy||Other: Blood samples||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Case-control study|
|Masking:||None (Open Label)|
|Official Title:||Pain Perception, Headache Provocation and Multiomics of People Who Are Unable to Have Headache|
|Actual Study Start Date :||October 1, 2019|
|Estimated Primary Completion Date :||May 1, 2020|
|Estimated Study Completion Date :||May 1, 2022|
Cold Pressor Test
The participants are instructed to keep the non-dominant hand submerged in ice-water for as long as possible with a maximum of 10 minutes.
Other: Blood samples
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.
- Transcriptomic changes [ Time Frame: 1 hour ]Difference in RNA expression between cases and controls after Cold Pressor Test.
- Metabolomic changes [ Time Frame: 1 hour ]Difference in metabolites between cases and controls after Cold Pressor Test.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04220580
|Contact: Isa A Olofsson, MD||+45 38 63 20 email@example.com|
|Danish Headache Center||Recruiting|
|Glostrup, Region H, Denmark, 2600|
|Contact: Isa A Olofsson, MD +45 38 63 20 62 firstname.lastname@example.org|
|Principal Investigator: Isa A Olofsson, MD|
|Study Director:||Jes Olesen, Professor||Danish Headache Center|