fMRI of the Brainstem in Migraine Sufferers and Controls. Does Iron Deposition Correlate With Progression of Disease?
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.
Chronic Daily Migraine
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||fMRI of the Brainstem in Migraine Sufferers and Controls. Does Iron Deposition Correlate With Progression of Disease?|
- assess anatomical changes with emphasis in iron deposition in brainstem structures of migraineurs and controls [ Time Frame: within a month after consent is obtained ] [ Designated as safety issue: No ]
- correlate outcomes with headache surrogates (frequency, time since onset and age) [ Time Frame: within one month after enrollment ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Study Completion Date:||August 2009|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
|1 episodic migraine sufferers|
|2 chronic migraine sufferers|
|3 non migraine sufferers (controls)|
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00868556
|United States, Ohio|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Stewart J Tepper, MD||The Cleveland Clinic|