Functional MRI (fMRI) in CGRP Induced Migraine

NCT00363532 | Completed

• 1 other identifier: KA-20060083
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Migraine Without Aura

Keywords

migraine with out aura

Outcome Measures

Primary Outcomes (2)

• Changes in BOLD response before and after CGRP infusion.

• Changes in BOLD response before and after injection of sumatriptan.

Interventions

infusion of calcitonin gene related peptide (CGRP) DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

Danish Headache Center, Neurological Dep. Glostrup hospital

Glostrup Municipality, 2770, Denmark

Location

MeSH Terms

Conditions

Migraine without Aura

Condition Hierarchy (Ancestors)

Migraine Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Messoud Ashina, MD,PH.d

  Danish Headache Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 11, 2006
• First Posted: August 15, 2006
• Study Start: September 1, 2006
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: January 28, 2009

Record last verified: 2009-01

Locations

DK (1)