Back to resultsMultiomics After Cold Pressor Test of People Who Are Unable to Have Headache
Primary Purpose
Headache, Headache Disorders, Healthy
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Blood samples
Sponsored by
About this trial
This is an interventional other trial for Headache
Eligibility Criteria
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.
Sites / Locations
- Danish Headache Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Cold Pressor Test
Arm Description
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.
Outcomes
Primary Outcome Measures
Transcriptomic changes
Difference in RNA expression between cases and controls after Cold Pressor Test.
Metabolomic changes
Difference in metabolites between cases and controls after Cold Pressor Test.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04220580
Brief Title
Multiomics After Cold Pressor Test of People Who Are Unable to Have Headache
Official Title
Pain Perception, Headache Provocation and Multiomics of People Who Are Unable to Have Headache
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
March 12, 2020 (Actual)
Study Completion Date
March 12, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Headache Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Headache Disorders, Healthy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Case-control study
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cold Pressor Test
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Blood samples
Intervention Description
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.
Primary Outcome Measure Information:
Title
Transcriptomic changes
Description
Difference in RNA expression between cases and controls after Cold Pressor Test.
Time Frame
1 hour
Title
Metabolomic changes
Description
Difference in metabolites between cases and controls after Cold Pressor Test.
Time Frame
1 hour
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jes Olesen, Professor
Organizational Affiliation
Danish Headache Center
Official's Role
Study Director
Facility Information:
Facility Name
Danish Headache Center
City
Glostrup
State/Province
Region H
ZIP/Postal Code
2600
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Multiomics After Cold Pressor Test of People Who Are Unable to Have Headache
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