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

Migraine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02066558
• Other study ID #: H-3-2013-194
• Status: Completed
• Phase: N/A
• First received: February 17, 2014
• Last updated: February 11, 2015
• Start date: February 2014
• Est. completion date: December 2014

Study information

• Verified date: February 2015
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Headache
• Migraine

Intervention

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

Locations

Country	Name	City	State
Denmark	Danish Headache Center	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache scores	Comparison between carbon monoxide and placebo (atmospheric air)	12 h	No
Secondary	Blood flow velocity	Carbon monoxide induced changes in blood flow velocity in the middle cerebral artery before and after inhalation.	0-180 min after inhalation	No
Secondary	Artery circumference	Carbon monoxide induced changes in the superficial temporal artery and the radial artery before and after inhalation.	0-180 min	No
Secondary	Facial blood flow	Carbon monoxide induced changes in facial blood flow before and after inhalation.	0-180 min	No