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

NCT ID: NCT02066558

Last Updated: 2015-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2014-12-31

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.

Conditions

Headache; Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

carbon monoxide

Inhalation of carbon monoxide up to a carboxyhemoglobin concentration of 12% and 22%.

Group Type: ACTIVE_COMPARATOR

Carbon monoxide

Intervention Type: 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

Atmospheric air

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Interventions

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.

Intervention Type: OTHER

Placebo

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Danish Headache Center

OTHER

Sponsor Role: lead

Responsible Party

Nanna Arngrim

MD, medical doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nanna Arngrim, MD

Role: PRINCIPAL_INVESTIGATOR

Danish Headache Center, Glostrup Hospital

Locations

Danish Headache Center

Glostrup Municipality, Denmark, Denmark

Countries

Denmark

Other Identifiers

H-3-2013-194

Identifier Type: -

Identifier Source: org_study_id