Functional MRI (fMRI) in CGRP Induced Migraine
Information source: Danish Headache Center
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Migraine With Out Aura
Intervention: infusion of calcitonin gene related peptide (CGRP) (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Danish Headache Center Official(s) and/or principal investigator(s):
Messoud Ashina, MD,PH.d, Study Chair, Affiliation: Danish Headache Center
Overall contact:
Mohammad Sohail Asghar, MD, Phone: +4543232161, Email: asgsoh01@glostruphosp.kbhamt.dk
Summary
In patients known with migraine without aura a migraine headache or migraine like headache
will be induced by infusion of calcitonin gene related peptide (CGRP). The patients will then
be stimulated with noxious heat via a thermode placed at the forehead. At the same time the
Blood-oxygenation-level-dependent (BOLD) response will be measured via functional magnetic
ressonanse imaging (fMRI), to estimate the central-nervous pain response. The regions of
interest (ROI) will be thalamic region and medulla oblongata.
Then the patients will be given pain relif in form of injection of sumatriptan and the effect
of this will also be registered via measuring the BOLD response at the RIO's previously
defined. A 3-Tesla MRI scanner will be used in this trail.
This study will give us key knowledge of the trigeminal pain pathway and the central
processing i. e sensitization during a migraine attach.
Clinical Details
Official title: Functional MRI (fMRI) in Patients With Migraine Without Aura Provoked by
Study design: Treatment, Non-Randomized, Single Blind, Uncontrolled, Single Group Assignment, Safety Study
Primary outcome: Changes in BOLD respons before and after CGRP infusion.Changes in BOLD respons before and after injection of sumatriptan.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients know with migraine without aura.
- no less then 1 migraine attach pr month and no more then 6 attachs per month.
- weight 50-100 kg.
- women must be using secure birthcontrol.
Exclusion Criteria:
- Tension type headache more then 1 day/month.
- all other prim. og sec. headache types then migraine without aura.
- Daily use of medication other then birthcontrol pills.
- Pregnant and lactation women.
- Headache on the trail day or 5 days previous to the trail day.
- Contraindications to MRI-scanns.
- Hypertension or hypotension.
- known heart or lung condition.
- mental illness or substance abuse.
- Other considerable conditions judged by the examinating doctor.
Locations and Contacts
Mohammad Sohail Asghar, MD, Phone: +4543232161, Email: asgsoh01@glostruphosp.kbhamt.dk
Danish Headache Center, Neurological Dep. Glostrup hospital, Glostrup 2770, Denmark
Additional Information
Starting date: September 2006
Ending date: August 2007
Last updated: August 11, 2006
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