Clinical trial NCT01741246: Neuroimaging Studies of Chronic Primary Headaches Using Positron Emission Tomography and Magnetic Resonance Imaging
Official title: Neuroimaging Studies of Chronic Primary Headaches Using Positron Emission Tomography and Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Chronic Migraine
Keywords: Episodic migraine
Chronic migraine
Magnetic resonance imaging
Positron emission tomography
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2012-12-04
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
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).

Brief summary: 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.

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 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

Primary outcomes:
measure: Pattern of brain metabolism using positron emission tomography(PET).
timeFrame: Estimated to be approximately three years post baseline
measure: Changes of resting state brain networks using magnetic resonance imaging (MRI)
timeFrame: Estimated to be approximately three years post baseline
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF
state: California
Study officials:
affiliation: University of California, San Francisco
name: Amy Tso, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Peter Goadsby, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Amy Gelfand, MD
role: PRINCIPAL_INVESTIGATOR
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