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Neuroimaging Studies of Chronic Primary Headaches Using Positron Emission Tomography and Magnetic Resonance Imaging

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01741246
First Posted: December 4, 2012
Last Update Posted: June 30, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Allergan
Information provided by (Responsible Party):
University of California, San Francisco
  Purpose
Investigators hypothesize that chronic primary headaches are accompanied by a discrete pattern of brain metabolism and activity involving brain structures related to the development of acute exacerbations as well as pain modulation. Such structures include the brainstem, hypothalamus, and orbitofrontal cortex and can be defined using functional brain imaging.

Condition
Migraine Chronic Migraine

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Neuroimaging Studies of Chronic Primary Headaches Using Positron Emission Tomography and Magnetic Resonance Imaging

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Pattern of brain metabolism using positron emission tomography(PET). [ Time Frame: Estimated to be approximately three years post baseline ]
    Neuroimaging Studies of Chronic Primary Headaches Using Positron Emission Tomography and Magnetic Resonance Imaging to determine the pattern of brain metabolism.

  • Changes of resting state brain networks using magnetic resonance imaging (MRI) [ Time Frame: Estimated to be approximately three years post baseline ]
    Neuroimaging Studies of Chronic Primary Headaches Using Positron Emission Tomography and Magnetic Resonance Imaging (MRI) To determine any changes of resting state brain networks


Enrollment: 78
Study Start Date: September 2011
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Control
Headache-free subjects.
Episodic migraine
Patients with less that 15 headache days per month that fulfill International Classification of Headache Disorders 2R (ICHD-2nd edition Revised)- criteria for Episodic Migraine.
Chronic migraine
Patients that fulfill International Classification of Headache Disorders (ICHD)-2R criteria for chronic migraine (more than 15 days per month).

Detailed Description:

Specific aims of the study include:

  1. To determine the pattern of brain metabolism using positron emission tomography (PET) found in chronic migraine, episodic migraine and control patients.
  2. To determine changes of resting state brain networks using magnetic resonance imaging (MRI) between patients with chronic or episodic headache and healthy volunteers.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with episodic migraine, chronic migraine and control patients. Definitions are taken for the International Classification of Headache Disorders-2nd Edition (see references).
Criteria

Inclusion Criteria:

  • Patients aged 18-65

    • No medical contraindication.

Chronic headache group:

  • Patients with chronic primary headaches who are experiencing phases with background pain as well as habitual pain exacerbations.
  • Able to provide informed consent.
  • Not pregnant or planning to become so, with a pregnancy test prior to scanning.

Control group and Episodic migraine group:

  • Patients with episodic migraine
  • Able to provide informed consent.
  • Not pregnant or planning to become so, with a pregnancy test prior to scanning.

Exclusion Criteria:

  • Taking a migraine preventive currently or in the last fifteen days.
  • Known claustrophobia
  • Patient is pregnant, planning to be pregnant, or becomes pregnant.
  • Patients with metal implants.
  • Patients who have had a study involving radiation within the one year prior to enrolling in this study
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01741246


Locations
United States, California
UCSF
San Francisco, California, United States, 94115 & 94158
Sponsors and Collaborators
University of California, San Francisco
Allergan
Investigators
Principal Investigator: Amy Tso, MD University of California, San Francisco
Principal Investigator: Peter Goadsby, MD PhD University of California, San Francisco
Principal Investigator: Amy Gelfand, MD University of California, San Francisco
  More Information

Publications:
Talairach J, Tournoux P. Coplanar Stereotaxic Atlas of the Human Brain. New York: Thieme; 1988.
Valk PE, Delbeke D, Bailey DL, D.W. T, Maisey MN. Positron Emission Tomography: Springer; 2006.
Sprenger T, Seifert CL, Valet M, Staehle KS, Tölle TR, Foerschler A, Zimmer C, Goadsby PJ. Abnormal Interictal Resting State Activity in Episodic Migraine. Presented at the 62nd Annual Meeting of the American Academy of Neurology 2010, Toronto.

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01741246     History of Changes
Other Study ID Numbers: 1107004
First Submitted: November 26, 2012
First Posted: December 4, 2012
Last Update Posted: June 30, 2015
Last Verified: June 2015

Keywords provided by University of California, San Francisco:
Episodic migraine
Chronic migraine
Magnetic resonance imaging
Positron emission tomography

Additional relevant MeSH terms:
Migraine Disorders
Headache
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms