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Completed

NCT Number: NCT02066558

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.

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Key information

Conditions

Headache Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Migraine Disorders Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Danish Headache Center

Glostrup Municipality, Denmark, 2600

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carbon monoxide

Other

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

Other

Primary outcomes

  1. Headache scores

    Time frame: 12 h

    Comparison between carbon monoxide and placebo (atmospheric air)

Secondary outcomes

  1. 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.

  2. Artery circumference

    Time frame: 0-180 min

    Carbon monoxide induced changes in the superficial temporal artery and the radial artery before and after inhalation.

  3. Facial blood flow

    Time frame: 0-180 min

    Carbon monoxide induced changes in facial blood flow before and after inhalation.

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 19, 2014
Registry last updated
Feb 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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