fMRI of the Brainstem in Migraine Sufferers and Controls. Does Iron Deposition Correlate With Progression of Disease?

Completed

• Conditions: Episodic Migraine; Chronic Daily Migraine

• Registration Number: NCT00868556
• Lead Sponsor: The Cleveland Clinic

Brief Summary

This is a 2 visit research study for patients with or without a diagnosis of migraine. Participants will be administered informed consent, have a medical history taken and a physical examination performed, and complete 3 questionnaires at the first visit. The participants will have a functional MRI performed after completion of Visit 1. Study stipends will be given for each completed research visit.

The purpose of this study is to potentially identify risk factors and/or biomarkers (which are differences in the brain structures)by comparing the brain MRI scans of migraine sufferers to brain scans of control persons to attempt to identify migraine progression using the functional MRI scans.

Detailed Description

At Visit 1, patients in 3 diagnostic arms,(consisting of subjects with episodic migraine, chronic daily migraine or non-migraineurs/controls), of 11 subjects each, will be consented and then have a physical exam, medical history and current medication use documented. Each of these enrolled subjects will have a PRIME MD assessment administered, and will complete the MIDAS and ASC-12 questionnaires.

At Visit 2 these same subjects will have an fMRI performed.

Subjects will be greater than age 18, have the appropriate diagnoses, be able to be consented and not be pregnant or have an inability to have the fMRI performed (have implanted metal devices, have severe claustrophobia).

Study Timeline

• Study Start: 2009-01
• Status Verified: 2009-03
• Study First Submitted: 2009-03-24
• Study First Submitted QC: 2009-03-24
• Study First Posted: 2009-03-25
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Last Update Submitted: 2010-01-04
• Last Update Posted: 2010-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• adult episodic, chronic or non-migraine sufferers able to consent

Exclusion Criteria

• contraindication to MRI such as severe claustrophobia and implanted devices such as neurostimulators, pacemakers, aneurysm clips, etc
• pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
assess anatomical changes with emphasis in iron deposition in brainstem structures of migraineurs and controls	within a month after consent is obtained

Secondary Outcome Measures

Name	Time	Method
correlate outcomes with headache surrogates (frequency, time since onset and age)	within one month after enrollment

Trial Locations

Locations (1)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States