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

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ClinicalTrials.gov Identifier: NCT01896167
Recruitment Status : Completed
First Posted : July 11, 2013
Last Update Posted : February 12, 2015
Sponsor:
Information provided by (Responsible Party):
Nanna Arngrim, Danish Headache Center

June 21, 2013
July 11, 2013
February 12, 2015
April 2013
September 2014   (Final data collection date for primary outcome measure)
Headache and aura [ Time Frame: 24 h ]
Comparison between hypoxia and placebo (atmospheric air)
Same as current
Complete list of historical versions of study NCT01896167 on ClinicalTrials.gov Archive Site
  • artery circumference [ Time Frame: Baseline, 120 and 200 min ]
    Hypoxia induced changes in intra- and extracranial circumference
  • Cerebral blood flow [ Time Frame: Baseline, 120 and 200 min ]
    Hypoxia induced changes in cerebral blood flow
  • BOLD response in visual cortex [ Time Frame: Baseline, 170 min and 220 min ]
    Hypoxia induced changes in BOLD response
  • Brain metabolism [ Time Frame: Baseline, 180 min and 230 min post hypoxia ]
    Hypoxia induced changes in brain metabolism
  • artery circumference [ Time Frame: Baseline, 90 and 180 min ]
    Hypoxia induced changes in intra- and extracranial circumference
  • Cerebral blood flow [ Time Frame: Baseline, 90 and 180 min ]
    Hypoxia induced changes in cerebral blood flow
  • Resting state functional connectivity [ Time Frame: Baseline and approximately 15 min post hypoxia ]
    To identify specific patterns in resting state functional connectivity (RSFC) in the pre-ictal stage of a migraine attack induced by hypoxia
Not Provided
Not Provided
 
Migraine With Aura Inducing Characteristics and Effects on the Cerebral Arteries and Blood Flow by Hypoxia
Study of Migraine With Aura Inducing Characteristics and Effects on the Cerebral Arteries by Hypoxia in a Humane Experimental Migraine Model

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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
  • Headache
  • Migraine
  • Aura
  • Other: Hypoxia
    Inhalation of hypoxic air (8-12% oxygen content)
  • Other: Placebo
    Inhalation of atmospheric air
  • Active Comparator: Hypoxia
    Inhalation of air with 8-12% oxygen content
    Intervention: Other: Hypoxia
  • Placebo Comparator: Atmospheric air
    Inhalation of atmospheric air, with oxygen content at 21%
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
12
September 2014
September 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT01896167
H-4-2012-182
No
Not Provided
Not Provided
Nanna Arngrim, Danish Headache Center
Danish Headache Center
Not Provided
Principal Investigator: Nanna Arngrim, MD Department of Neurology, Glostrup Hospital
Danish Headache Center
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP