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Trial record 1 of 1 for:    NCT01896167
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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

Tracking Information
First Submitted Date  ICMJE June 21, 2013
First Posted Date  ICMJE July 11, 2013
Last Update Posted Date February 12, 2015
Study Start Date  ICMJE April 2013
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2013)
Headache and aura [ Time Frame: 24 h ]
Comparison between hypoxia and placebo (atmospheric air)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2015)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2013)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Migraine With Aura Inducing Characteristics and Effects on the Cerebral Arteries and Blood Flow by Hypoxia
Official Title  ICMJE Study of Migraine With Aura Inducing Characteristics and Effects on the Cerebral Arteries by Hypoxia in a Humane Experimental Migraine Model
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Headache
  • Migraine
  • Aura
Intervention  ICMJE
  • Other: Hypoxia
    Inhalation of hypoxic air (8-12% oxygen content)
  • Other: Placebo
    Inhalation of atmospheric air
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 11, 2015)
34
Original Estimated Enrollment  ICMJE
 (submitted: July 8, 2013)
12
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01896167
Other Study ID Numbers  ICMJE H-4-2012-182
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nanna Arngrim, Danish Headache Center
Study Sponsor  ICMJE Danish Headache Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nanna Arngrim, MD Department of Neurology, Glostrup Hospital
PRS Account Danish Headache Center
Verification Date February 2015

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