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CompletedNCT01896167Updated Feb 12, 2015

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

An interventional study of Hypoxia and Placebo in Headache, Migraine and Aura, sponsored by Danish Headache Center. Completed at 1 site in Denmark. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-02-12.

Sponsored by Danish Headache Center · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Headache
  • Migraine
  • Aura

Keywords

  • Headache
  • Migraine
  • Aura
  • Cerebral hemodynamics
03

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 34 is below the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Danish Headache Center is the lead sponsor of 125 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

Migraine with aura patients and Helthy volunteers as controls:

  • Aged 18-40
  • 50-100 kg

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
34 participants (actual)

Study arms

  • Active comparator
    Hypoxia

    Inhalation of air with 8-12% oxygen content

    Other: Hypoxia

  • Placebo comparator
    Atmospheric air

    Inhalation of atmospheric air, with oxygen content at 21%

    Other: Placebo

Interventions

  • OtherHypoxia

    Inhalation of hypoxic air (8-12% oxygen content)

  • OtherPlacebo

    Inhalation of atmospheric air

06

What researchers measure

Primary outcomes

  1. Headache and aura

    Comparison between hypoxia and placebo (atmospheric air)

    Time frame: 24 h

Secondary outcomes

  1. artery circumference

    Hypoxia induced changes in intra- and extracranial circumference

    Time frame: Baseline, 120 and 200 min

  2. Cerebral blood flow

    Hypoxia induced changes in cerebral blood flow

    Time frame: Baseline, 120 and 200 min

  3. BOLD response in visual cortex

    Hypoxia induced changes in BOLD response

    Time frame: Baseline, 170 min and 220 min

  4. Brain metabolism

    Hypoxia induced changes in brain metabolism

    Time frame: Baseline, 180 min and 230 min post hypoxia

07

Study locations

1 site
  • Nanna Arngrim
    Glostrup, 2600, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01896167
Lead sponsor
Danish Headache Center
Responsible party
Nanna Arngrim (MD, medical doctors, Danish Headache Center) — Principal investigator
First posted
Jul 11, 2013
Start date
Apr 2013
Primary completion
Sep 2014
Completion
Sep 2014
Last update
Feb 12, 2015

Study contacts

Nanna Arngrim, MD
principal investigator · Department of Neurology, Glostrup Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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