Carbon Monoxide's Headache Inducing Characteristics and Effects on the Cerebral Arteries and Blood Flow
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.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
|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|
- Headache scores [ Time Frame: 12 h ] [ Designated as safety issue: No ]Comparison between carbon monoxide and placebo (atmospheric air)
- Blood flow velocity [ Time Frame: 0-180 min after inhalation ] [ Designated as safety issue: No ]Carbon monoxide induced changes in blood flow velocity in the middle cerebral artery before and after inhalation.
- Artery circumference [ Time Frame: 0-180 min ] [ Designated as safety issue: No ]Carbon monoxide induced changes in the superficial temporal artery and the radial artery before and after inhalation.
- Facial blood flow [ Time Frame: 0-180 min ] [ Designated as safety issue: No ]Carbon monoxide induced changes in facial blood flow before and after inhalation.
|Study Start Date:||February 2014|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Active Comparator: carbon monoxide
Inhalation of carbon monoxide up to a carboxyhemoglobin concentration of 12% and 22%.
Other: Carbon monoxide
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.
Placebo Comparator: placebo
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02066558
|Contact: Nanna Arngrim, MD||38634612 ext firstname.lastname@example.org|
|Contact: Messoud Ashina, MD, PhD, MSc||38632062 ext email@example.com|
|Danish Headache Center||Recruiting|
|Glostrup, Denmark, 2600|
|Contact: Nanna Arngrim, MD 38 63 46 12 ext 0045 firstname.lastname@example.org|
|Principal Investigator: Nanna Arngrim, MD|
|Sub-Investigator: Josefine Britze, BSc|
|Principal Investigator:||Nanna Arngrim, MD||Danish Headache Center, Glostrup Hospital|