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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

Brief 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.

Condition or disease Intervention/treatment Phase
Headache Migraine Aura Other: Hypoxia Other: Placebo Not Applicable

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Study of Migraine With Aura Inducing Characteristics and Effects on the Cerebral Arteries by Hypoxia in a Humane Experimental Migraine Model
Study Start Date : April 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Hypoxia
Inhalation of air with 8-12% oxygen content
Other: Hypoxia
Inhalation of hypoxic air (8-12% oxygen content)
Placebo Comparator: Atmospheric air
Inhalation of atmospheric air, with oxygen content at 21%
Other: Placebo
Inhalation of atmospheric air



Primary Outcome Measures :
  1. Headache and aura [ Time Frame: 24 h ]
    Comparison between hypoxia and placebo (atmospheric air)


Secondary Outcome Measures :
  1. artery circumference [ Time Frame: Baseline, 120 and 200 min ]
    Hypoxia induced changes in intra- and extracranial circumference

  2. Cerebral blood flow [ Time Frame: Baseline, 120 and 200 min ]
    Hypoxia induced changes in cerebral blood flow

  3. BOLD response in visual cortex [ Time Frame: Baseline, 170 min and 220 min ]
    Hypoxia induced changes in BOLD response

  4. Brain metabolism [ Time Frame: Baseline, 180 min and 230 min post hypoxia ]
    Hypoxia induced changes in brain metabolism



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01896167


Locations
Denmark
Nanna Arngrim
Glostrup, Denmark, 2600
Sponsors and Collaborators
Danish Headache Center
Investigators
Principal Investigator: Nanna Arngrim, MD Department of Neurology, Glostrup Hospital

Responsible Party: Nanna Arngrim, MD, medical doctors, Danish Headache Center
ClinicalTrials.gov Identifier: NCT01896167     History of Changes
Other Study ID Numbers: H-4-2012-182
First Posted: July 11, 2013    Key Record Dates
Last Update Posted: February 12, 2015
Last Verified: February 2015

Keywords provided by Nanna Arngrim, Danish Headache Center:
Headache
Migraine
Aura
Cerebral hemodynamics

Additional relevant MeSH terms:
Migraine Disorders
Headache
Hypoxia
Migraine with Aura
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Respiratory