fMRI of the Brainstem in Migraine Sufferers and Controls. Does Iron Deposition Correlate With Progression of Disease?
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|ClinicalTrials.gov Identifier: NCT00868556|
Recruitment Status : Completed
First Posted : March 25, 2009
Last Update Posted : January 5, 2010
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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.
|Condition or disease|
|Episodic Migraine Chronic Daily Migraine|
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 Type :||Observational|
|Actual Enrollment :||33 participants|
|Official Title:||fMRI of the Brainstem in Migraine Sufferers and Controls. Does Iron Deposition Correlate With Progression of Disease?|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||August 2009|
|1 episodic migraine sufferers|
|2 chronic migraine sufferers|
|3 non migraine sufferers (controls)|
- assess anatomical changes with emphasis in iron deposition in brainstem structures of migraineurs and controls [ Time Frame: within a month after consent is obtained ]
- correlate outcomes with headache surrogates (frequency, time since onset and age) [ Time Frame: within one month after enrollment ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
- adult episodic, chronic or non-migraine sufferers able to consent
- contraindication to MRI such as severe claustrophobia and implanted devices such as neurostimulators, pacemakers, aneurysm clips, etc
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00868556
|United States, Ohio|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Stewart J Tepper, MD||The Cleveland Clinic|
|Responsible Party:||Stewart Tepper MD, PI, Cleveland Clinic Foundation|
|Other Study ID Numbers:||
Merck Grant IISP 36047
|First Posted:||March 25, 2009 Key Record Dates|
|Last Update Posted:||January 5, 2010|
|Last Verified:||March 2009|
episodic migraine sufferers
chronic migraine sufferers
non migraine sufferers (controls)
Headache Disorders, Primary
Central Nervous System Diseases
Nervous System Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases