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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04220580
Recruitment Status : Recruiting
First Posted : January 7, 2020
Last Update Posted : January 7, 2020
Sponsor:
Information provided by (Responsible Party):
Isa Amalie Olofsson, Danish Headache Center

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.


Condition or disease Intervention/treatment Phase
Headache Headache Disorders Healthy Other: Blood samples Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Case-control study
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Transcriptomic changes [ Time Frame: 1 hour ]
    Difference in RNA expression between cases and controls after Cold Pressor Test.

  2. Metabolomic changes [ Time Frame: 1 hour ]
    Difference in metabolites between cases and controls after Cold Pressor Test.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Isa A Olofsson, MD +45 38 63 20 62 isa.amalie.olofsson@regionh.dk

Locations
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Denmark
Danish Headache Center Recruiting
Glostrup, Region H, Denmark, 2600
Contact: Isa A Olofsson, MD    +45 38 63 20 62    isa.amalie.olofsson@regionh.dk   
Principal Investigator: Isa A Olofsson, MD         
Sponsors and Collaborators
Danish Headache Center
Investigators
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Study Director: Jes Olesen, Professor Danish Headache Center

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Responsible Party: Isa Amalie Olofsson, Principal Investigator, Danish Headache Center
ClinicalTrials.gov Identifier: NCT04220580    
Other Study ID Numbers: HR004 Multiomics Pain
First Posted: January 7, 2020    Key Record Dates
Last Update Posted: January 7, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Headache Disorders
Headache
Pain
Neurologic Manifestations
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases