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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01388894
Other study ID # MA-01
Secondary ID
Status Recruiting
Phase N/A
First received July 5, 2011
Last updated July 5, 2011
Start date December 2010

Study information

Verified date May 2011
Source Glostrup University Hospital, Copenhagen
Contact Anders Hougaard, MD
Phone +4538632713
Email andhou05@glo.regionh.dk
Is FDA regulated No
Health authority Denmark: The Regional Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
Study type Observational

Clinical Trial Summary

Patients who report that exposure to bright light or strenuous physical activity will induce migraine aura will be provoked using one or both of these methods. Followingly the patients will be examined by functional MRI. Íf the patients develop migraine headache, MR angiography will be performed as well. The primary study hypothesis is that the functional MRI signal will show features similar to those of the electrophysiological phenomenon of cortical spreading depression.


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Diagnosed with migraine with aura as defined by The International Classification of Headache Disorders 2

- Age between 18 and 80 years both inclusive

- Reports that bright light or strenuous physical activity may trigger migraine aura

Exclusion Criteria:

- Contraindications towards exposure to photostimulation or strenuous exercise

- Body weight above 130 kg

- Pregnant or lactating females

- Contraindications towards MRI scanning

- History or clinical signs of: cardiovascular disease, psychiatric disease, substance abuse or any symptom or disease considered relevant by the examining physician.

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Denmark Danish Headache Center Glostrup

Sponsors (1)

Lead Sponsor Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

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