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
1 other identifier
interventional
34
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 21, 2013
CompletedFirst Posted
Study publicly available on registry
July 11, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedFebruary 12, 2015
February 1, 2015
1.4 years
June 21, 2013
February 11, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Headache and aura
Comparison between hypoxia and placebo (atmospheric air)
24 h
Secondary Outcomes (4)
artery circumference
Baseline, 120 and 200 min
Cerebral blood flow
Baseline, 120 and 200 min
BOLD response in visual cortex
Baseline, 170 min and 220 min
Brain metabolism
Baseline, 180 min and 230 min post hypoxia
Study Arms (2)
Hypoxia
ACTIVE COMPARATORInhalation of air with 8-12% oxygen content
Atmospheric air
PLACEBO COMPARATORInhalation of atmospheric air, with oxygen content at 21%
Interventions
Eligibility Criteria
You may qualify if:
- Migraine with aura patients and Helthy volunteers as controls:
- Aged 18-40
You may not qualify if:
- 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
- migraine at present or earlier in life
- parents, sibling or children who suffer or have suffered from migraine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nanna Arngrim
Glostrup Municipality, 2600, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nanna Arngrim, MD
Department of Neurology, Glostrup Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, medical doctors
Study Record Dates
First Submitted
June 21, 2013
First Posted
July 11, 2013
Study Start
April 1, 2013
Primary Completion
September 1, 2014
Study Completion
September 1, 2014
Last Updated
February 12, 2015
Record last verified: 2015-02