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Clinical Trials/NCT00868556
NCT00868556
Completed
Not Applicable

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

The Cleveland Clinic1 site in 1 country33 target enrollmentJanuary 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Episodic Migraine
Sponsor
The Cleveland Clinic
Enrollment
33
Locations
1
Primary Endpoint
assess anatomical changes with emphasis in iron deposition in brainstem structures of migraineurs and controls
Status
Completed
Last Updated
16 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
August 2009
Last Updated
16 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

assess anatomical changes with emphasis in iron deposition in brainstem structures of migraineurs and controls

Time Frame: within a month after consent is obtained

Secondary Outcomes

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

Study Sites (1)

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