MRA/fMRI Study of Spontaneous Migraine

Headache Versus Non-headache Day Clinical Trial

Official title:

Functional MRI and MR Angiography Used in Spontaneous Migraine

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01471314
• Other study ID #: H-C-2008-089
• Status: Recruiting
• Phase: N/A
• First received: November 10, 2011
• Last updated: August 28, 2012

Study information

• Verified date: August 2012
• Source: Glostrup University Hospital, Copenhagen
• Contact: Faisal Amin, MD, PhD student
• Phone: +4538633066
• Email: famoam01[@]regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to examine migraineurs during spontaneous migraine attacks without aura, using high resolution magnetic resonance imaging (MRI), to study following:

• Changes in resting state blood-oxygenation-level-dependent-signal (BOLD-signal) using functional MRI (fMRI).

• Changes in circumferences of intra- and extracranial arteries using MR-angiography (MRA).

• Changes in regional and global cerebral blood flow (CBF) using the arterial spin labeling (ASL) method.

Moreover to perform diffusion tensor imaging (DTI) scans during spontaneous migraine attacks.

The migraine specific drug sumatriptan will be given to relieve pain and the effect will be registered using MRA and fMRI if possible.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Migraine without aura according to IHS criteria.

Exclusion Criteria:

• Other primary headaches.

• Tension-type headache more than 5 days/month.

• Use of anti-pain medication before the scanning on the examination day.

• Pregnant or nursing women.

• Contraindication for MR scan.

• Anamnestic or clinical signs of cardiovascular or cerebrovascular disease, unregulated psychiatric disease or drug misuse.

• Other clinical conditions assessed by the examining doctor.

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Headache Versus Non-headache Day

Intervention

Behavioral:
• Headache day versus non-headache day

Locations

Country	Name	City	State
Denmark	Glostrup Hospital, Faculty of Health Sciences, University of Copenhagen	Glostrup

Sponsors (2)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen	Leiden University Medical Center

Country where clinical trial is conducted

Denmark,