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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00868556
First received: March 24, 2009
Last updated: January 4, 2010
Last verified: March 2009
  Purpose

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
Episodic Migraine
Chronic Daily Migraine

Study Type: Observational
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?

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • correlate outcomes with headache surrogates (frequency, time since onset and age) [ Time Frame: within one month after enrollment ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: January 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1 episodic migraine sufferers
2 chronic migraine sufferers
3 non migraine sufferers (controls)

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

11 episodic migraine sufferers, 11 chronic migraine sufferers, 11 non-migraine sufferers

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00868556

Locations
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Stewart J Tepper, MD The Cleveland Clinic
  More Information

Publications:
Responsible Party: Stewart Tepper MD, PI, Cleveland Clinic Foundation
ClinicalTrials.gov Identifier: NCT00868556     History of Changes
Other Study ID Numbers: V81708, Merck Grant IISP 36047
Study First Received: March 24, 2009
Last Updated: January 4, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
fMRI scans
episodic migraine sufferers
chronic migraine sufferers
non migraine sufferers (controls)

Additional relevant MeSH terms:
Migraine Disorders
Siderosis
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Lung Diseases
Lung Diseases, Interstitial
Lung Injury
Nervous System Diseases
Occupational Diseases
Pneumoconiosis
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 22, 2014