Carbon Monoxide's Headache Inducing Characteristics and Effects on the Cerebral Arteries and Blood Flow

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Danish Headache Center
Sponsor:
Information provided by (Responsible Party):
Nanna Arngrim, Danish Headache Center
ClinicalTrials.gov Identifier:
NCT02066558
First received: February 17, 2014
Last updated: February 18, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Headache
Migraine
Other: Carbon monoxide
Other: Placebo

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Danish Headache Center:

Primary Outcome Measures:
  • Headache scores [ Time Frame: 12 h ] [ Designated as safety issue: No ]
    Comparison between carbon monoxide and placebo (atmospheric air)


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 12
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)
Arms Assigned Interventions
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
Atmospheric air
Other: Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02066558

Contacts
Contact: Nanna Arngrim, MD 38634612 ext 0045 nanna.bjoerkbom.arngrim.01@regionh.dk
Contact: Messoud Ashina, MD, PhD, MSc 38632062 ext 0045 hovedpine@regionh.dk

Locations
Denmark
Danish Headache Center Recruiting
Glostrup, Denmark, 2600
Contact: Nanna Arngrim, MD    38 63 46 12 ext 0045    nanna.bjoerkbom.arngrim.01@regionh.dk   
Principal Investigator: Nanna Arngrim, MD         
Sub-Investigator: Josefine Britze, BSc         
Sponsors and Collaborators
Danish Headache Center
Investigators
Principal Investigator: Nanna Arngrim, MD Danish Headache Center, Glostrup Hospital
  More Information

No publications provided

Responsible Party: Nanna Arngrim, MD, medical doctor, Danish Headache Center
ClinicalTrials.gov Identifier: NCT02066558     History of Changes
Other Study ID Numbers: H-3-2013-194
Study First Received: February 17, 2014
Last Updated: February 18, 2014
Health Authority: Denmark: Ethics Committee

Keywords provided by Danish Headache Center:
Carbon monoxide
Headache
Migraine

Additional relevant MeSH terms:
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Carbon Monoxide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Gasotransmitters
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 22, 2014