Back to resultsCarbon Monoxide's Headache Inducing Characteristics and Effects on the Cerebral Arteries and Blood Flow
Primary Purpose
Headache, Migraine
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Carbon monoxide
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Headache focused on measuring Carbon monoxide, Headache, Migraine
Eligibility Criteria
Inclusion Criteria:
- Healthy volunteers
- Aged 18-50
- 50-100 kg
Exclusion Criteria:
- Tension type headache more than once/month
- Other primary headaches
- Daily medication except contraceptives
- Drug taken within 4 times the halflife for the specific drug except contraceptives
- Pregnant or lactating women
- Exposure to radiation within the last year
- Headache within the last 24 hours before start of trial
- Hypertension
- Hypotension
- Respiratory or cardiac disease
- Smoking
- Primary relatives with current or previous migraine
Sites / Locations
- Danish Headache Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
carbon monoxide
placebo
Arm Description
Inhalation of carbon monoxide up to a carboxyhemoglobin concentration of 12% and 22%.
Atmospheric air
Outcomes
Primary Outcome Measures
Headache scores
Comparison between carbon monoxide and placebo (atmospheric air)
Secondary Outcome Measures
Blood flow velocity
Carbon monoxide induced changes in blood flow velocity in the middle cerebral artery before and after inhalation.
Artery circumference
Carbon monoxide induced changes in the superficial temporal artery and the radial artery before and after inhalation.
Facial blood flow
Carbon monoxide induced changes in facial blood flow before and after inhalation.
Full Information
NCT ID
NCT02066558
First Posted
February 17, 2014
Last Updated
February 11, 2015
Sponsor
Danish Headache Center
1. Study Identification
Unique Protocol Identification Number
NCT02066558
Brief Title
Carbon Monoxide's Headache Inducing Characteristics and Effects on the Cerebral Arteries and Blood Flow
Official Title
Basic Research on Carbon Monoxide's Headache Inducing Characteristics and Effects on the Cerebral Arteries and Blood Flow in a Humane Experimental Headache Model
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Headache Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
In this study the investigators will research the hypothesis that the gas carbon monoxide induces headache and increases the blood flow velocity in the middle cerebral artery.
Detailed Description
To investigate headache score and accompanying symptoms during and after inhalation of carbon monoxide.
With transcranial Doppler imaging, c-scan and laser speckle the investigators will investigate changes in blood flow velocity of the middle cerebral artery (MCA), diameter of the superficial temporal artery (STA), the radial artery and facial skin perfusion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Headache, Migraine
Keywords
Carbon monoxide, Headache, Migraine
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
carbon monoxide
Arm Type
Active Comparator
Arm Description
Inhalation of carbon monoxide up to a carboxyhemoglobin concentration of 12% and 22%.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
Atmospheric air
Intervention Type
Other
Intervention Name(s)
Carbon monoxide
Intervention Description
carbon monoxide, 4.7, Purity 99.997, inhalation of carbon monoxide in a volume corresponding to carboxyhemoglobin 10 and 20%, calculated from baseline Hg and body mass.
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Headache scores
Description
Comparison between carbon monoxide and placebo (atmospheric air)
Time Frame
12 h
Secondary Outcome Measure Information:
Title
Blood flow velocity
Description
Carbon monoxide induced changes in blood flow velocity in the middle cerebral artery before and after inhalation.
Time Frame
0-180 min after inhalation
Title
Artery circumference
Description
Carbon monoxide induced changes in the superficial temporal artery and the radial artery before and after inhalation.
Time Frame
0-180 min
Title
Facial blood flow
Description
Carbon monoxide induced changes in facial blood flow before and after inhalation.
Time Frame
0-180 min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy volunteers
Aged 18-50
50-100 kg
Exclusion Criteria:
Tension type headache more than once/month
Other primary headaches
Daily medication except contraceptives
Drug taken within 4 times the halflife for the specific drug except contraceptives
Pregnant or lactating women
Exposure to radiation within the last year
Headache within the last 24 hours before start of trial
Hypertension
Hypotension
Respiratory or cardiac disease
Smoking
Primary relatives with current or previous migraine
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nanna Arngrim, MD
Organizational Affiliation
Danish Headache Center, Glostrup Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danish Headache Center
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
Carbon Monoxide's Headache Inducing Characteristics and Effects on the Cerebral Arteries and Blood Flow
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