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Multiomics After Cold Pressor Test of People Who Are Unable to Have Headache

Pain Perception, Headache Provocation and Multiomics of People Who Are Unable to Have Headache

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04220580
Enrollment
100
Registered
2020-01-07
Start date
2019-10-01
Completion date
2020-03-12
Last updated
2021-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Headache, Headache Disorders, Healthy

Brief summary

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.

Interventions

OTHERBlood 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.

Sponsors

Danish Headache Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

Case-control study

Eligibility

Sex/Gender
MALE
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Transcriptomic changes1 hourDifference in RNA expression between cases and controls after Cold Pressor Test.
Metabolomic changes1 hourDifference in metabolites between cases and controls after Cold Pressor Test.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026