Migraine With Aura Inducing Characteristics and Effects on the Cerebral Arteries and Blood Flow by Hypoxia

Migraine Clinical Trial

Official title:

Study of Migraine With Aura Inducing Characteristics and Effects on the Cerebral Arteries by Hypoxia in a Humane Experimental Migraine Model

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01896167
• Other study ID #: H-4-2012-182
• Status: Completed
• Phase: N/A
• First received: June 21, 2013
• Last updated: February 11, 2015
• Start date: April 2013
• Est. completion date: September 2014

Study information

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

Clinical Trial Summary

In this study the investigators will investigate the following hypothesis

• that hypoxia induce migraine headache and migraine aura

• the aura phase is associated with a spreading reduction in cerebral blood flow

• the migraine headache is associated with dilatation of intra- and extracerebral arteries

• the migraine headache is associated with changes in brain metabolism

• the pre-ictal stage of a migraine attack with aura is associated with specific patterns in neural activity.

Description:

To investigate migraine with aura symptoms during and after hypoxia.

With magnetic resonance imaging the investigators will investigate changes in

• regional cerebral blood flow (rCBF)

• resting state functional connectivity

• circumference of the middle cerebral artery(MCA), internal carotic artery, superficial temporal artery, medial meningeal artery, external carotic artery

• brain metabolism

And compare these changes with a aged match healthy control group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

Migraine with aura patients and Helthy volunteers as controls:

• Aged 18-40

• 50-100 kg

Exclusion Criteria:

• Tension type headache more than 5 days/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

• Headache or migraine attack within the last 48 hours before start of trial

• Hypertension

• Hypotension

• Respiratory or cardiac disease

• smoking

Extra exclusion Criteria for healthy volunteers:

• migraine at present or earlier in life

• parents, sibling or children who suffer or have suffered from 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

• Aura
• Headache
• Migraine
• Migraine Disorders
• Migraine with Aura

Intervention

Other:
• Hypoxia
Inhalation of hypoxic air (8-12% oxygen content)
• Placebo
Inhalation of atmospheric air

Locations

Country	Name	City	State
Denmark	Nanna Arngrim	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 and aura	Comparison between hypoxia and placebo (atmospheric air)	24 h	No
Secondary	artery circumference	Hypoxia induced changes in intra- and extracranial circumference	Baseline, 120 and 200 min	No
Secondary	Cerebral blood flow	Hypoxia induced changes in cerebral blood flow	Baseline, 120 and 200 min	No
Secondary	BOLD response in visual cortex	Hypoxia induced changes in BOLD response	Baseline, 170 min and 220 min	No
Secondary	Brain metabolism	Hypoxia induced changes in brain metabolism	Baseline, 180 min and 230 min post hypoxia	No