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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of California, San Francisco
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01741246
First received: November 26, 2012
Last updated: March 31, 2014
Last verified: March 2014

November 26, 2012
March 31, 2014
September 2011
December 2014   (final data collection date for primary outcome measure)
  • Pattern of brain metabolism using positron emission tomography(PET). [ Time Frame: Estimated to be approximately three years post baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Neuroimaging Studies of Chronic Primary Headaches Using Positron Emission Tomography and Magnetic Resonance Imaging (MRI) To determine any changes of resting state brain networks
Same as current
Complete list of historical versions of study NCT01741246 on ClinicalTrials.gov Archive Site
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Neuroimaging Studies of Chronic Primary Headaches Using Positron Emission Tomography and Magnetic Resonance Imaging
Neuroimaging Studies of Chronic Primary Headaches Using Positron Emission Tomography and Magnetic Resonance Imaging

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.

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.
Observational
Time Perspective: Prospective
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Non-Probability Sample

Patients with episodic migraine, chronic migraine and control patients. Definitions are taken for the International Classification of Headache Disorders-2nd Edition (see references).

  • Migraine
  • Chronic Migraine
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  • 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).

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
85
December 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact: Amy Tso, MD 4153538393 Amy.Tso@ucsfmedctr.org
United States
 
NCT01741246
1107004
No
University of California, San Francisco
University of California, San Francisco
Allergan
Principal Investigator: Amy Tso, MD University of California, San Francisco
Principal Investigator: Peter Goadsby, MBBS University of California, San Francisco
Principal Investigator: Amy Gelfand, MD University of California, San Francisco
University of California, San Francisco
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP