Text Size

Functional MRI (fMRI) in CGRP Induced Migraine

This study has been completed.
Sponsor:
Information provided by:
Danish Headache Center
ClinicalTrials.gov Identifier:
NCT00363532
First received: August 11, 2006
Last updated: January 27, 2009
Last verified: January 2009
History of Changes

August 11, 2006
January 27, 2009
September 2006
July 2007   (final data collection date for primary outcome measure)
  • Changes in BOLD response before and after CGRP infusion.
  • Changes in BOLD response before and after injection of sumatriptan.
  • Changes in BOLD respons before and after CGRP infusion.
  • Changes in BOLD respons before and after injection of sumatriptan.
Complete list of historical versions of study NCT00363532 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Functional MRI (fMRI) in CGRP Induced Migraine
Functional MRI (fMRI) in Patients With Migraine Without Aura Provoked by

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 resonance 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.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Migraine Without Aura
Drug: infusion of calcitonin gene related peptide (CGRP)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
July 2007
July 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients know with migraine without aura.
  • No less then 1 migraine attach pr month and no more then 6 attaches 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-scans.
  • Hypertension or hypotension.
  • Known heart or lung condition.
  • Mental illness or substance abuse.
  • Other considerable conditions judged by the including doctor.
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00363532
KA-20060083
Not Provided
Mohammad Sohail Asghar, MD, Neurological Dep. University of Copenhagen, Denmark, Glostrup Hospital.
Danish Headache Center
Not Provided
Study Chair: Messoud Ashina, MD,PH.d Danish Headache Center
Danish Headache Center
January 2009

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