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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02066558
First Posted: February 19, 2014
Last Update Posted: February 12, 2015
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Nanna Arngrim, Danish Headache Center
  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: Quadruple (Participant, Care Provider, 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 Nanna Arngrim, Danish Headache Center:

Primary Outcome Measures:
  • Headache scores [ Time Frame: 12 h ]
    Comparison between carbon monoxide and placebo (atmospheric air)


Secondary Outcome Measures:
  • Blood flow velocity [ Time Frame: 0-180 min after inhalation ]
    Carbon monoxide induced changes in blood flow velocity in the middle cerebral artery before and after inhalation.

  • Artery circumference [ Time Frame: 0-180 min ]
    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 ]
    Carbon monoxide induced changes in facial blood flow before and after inhalation.


Enrollment: 12
Study Start Date: February 2014
Study Completion Date: December 2014
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

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.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
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): NCT02066558


Locations
Denmark
Danish Headache Center
Glostrup, Denmark, 2600
Sponsors and Collaborators
Danish Headache Center
Investigators
Principal Investigator: Nanna Arngrim, MD Danish Headache Center, Glostrup Hospital
  More Information

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
First Submitted: February 17, 2014
First Posted: February 19, 2014
Last Update Posted: February 12, 2015
Last Verified: February 2015

Keywords provided by Nanna Arngrim, Danish Headache Center:
Carbon monoxide
Headache
Migraine

Additional relevant MeSH terms:
Headache
Headache Disorders, Primary
Headache Disorders
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Carbon Monoxide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gasotransmitters
Neurotransmitter Agents
Physiological Effects of Drugs