AzTrials
AzTrials

MigraineNCT01741246

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

An observational study of Migraine and Chronic Migraine, run by University of California, San Francisco at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Migraine, Chronic Migraine
How many people
78 participants
Where
1 siteUnited States
Study dates
Sep 2011to Jun 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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).

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCSF

    San Francisco, California, 94115 & 94158

Other trials in United States

About this study

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.

Read the 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.
Keywords
Episodic migraine, Chronic migraine, Magnetic resonance imaging, Positron emission tomography
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01741246
Study groupRoleWhat they receive
ControlHeadache-free subjects.
Episodic migrainePatients 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 migrainePatients that fulfill International Classification of Headache Disorders (ICHD)-2R criteria for chronic migraine (more than 15 days per month).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pattern of brain metabolism using positron emission tomography(PET).

    Neuroimaging Studies of Chronic Primary Headaches Using Positron Emission Tomography and Magnetic Resonance Imaging to determine the pattern of brain metabolism.

    Measured: Estimated to be approximately three years post baseline

  2. Changes of resting state brain networks using magnetic resonance imaging (MRI)

    Neuroimaging Studies of Chronic Primary Headaches Using Positron Emission Tomography and Magnetic Resonance Imaging (MRI) To determine any changes of resting state brain networks

    Measured: Estimated to be approximately three years post baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2012 (estimated)
  2. Study startSep 2011
  3. Primary completionJun 2015
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
78 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01741246
Sponsor's protocol ID
1107004
Status last verified
Jun 2015
First submitted
26 Nov 2012
Last updated
30 Jun 2015
Results posted
No
Data monitoring committee
No

Publications

  • Welch KM, Goadsby PJ. Chronic daily headache: nosology and pathophysiology. Curr Opin Neurol. 2002 Jun;15(3):287-95. doi: 10.1097/00019052-200206000-00011.

    PubMed 12045727

  • Scher AI, Stewart WF, Liberman J, Lipton RB. Prevalence of frequent headache in a population sample. Headache. 1998 Jul-Aug;38(7):497-506. doi: 10.1046/j.1526-4610.1998.3807497.x.

    PubMed 15613165

  • Bigal ME, Serrano D, Reed M, Lipton RB. Chronic migraine in the population: burden, diagnosis, and satisfaction with treatment. Neurology. 2008 Aug 19;71(8):559-66. doi: 10.1212/01.wnl.0000323925.29520.e7.

    PubMed 18711108

  • Bergerot A, Holland PR, Akerman S, Bartsch T, Ahn AH, MaassenVanDenBrink A, Reuter U, Tassorelli C, Schoenen J, Mitsikostas DD, van den Maagdenberg AM, Goadsby PJ. Animal models of migraine: looking at the component parts of a complex disorder. Eur J Neurosci. 2006 Sep;24(6):1517-34. doi: 10.1111/j.1460-9568.2006.05036.x.

    PubMed 17004916

  • Goadsby PJ, Lipton RB, Ferrari MD. Migraine--current understanding and treatment. N Engl J Med. 2002 Jan 24;346(4):257-70. doi: 10.1056/NEJMra010917. No abstract available.

    PubMed 11807151

  • Afridi SK, Goadsby PJ. Neuroimaging of migraine. Curr Pain Headache Rep. 2006 Jun;10(3):221-4. doi: 10.1007/s11916-006-0049-4.

    PubMed 18778577

  • Weiller C, May A, Limmroth V, Juptner M, Kaube H, Schayck RV, Coenen HH, Diener HC. Brain stem activation in spontaneous human migraine attacks. Nat Med. 1995 Jul;1(7):658-60. doi: 10.1038/nm0795-658.

    PubMed 7585147

  • Bahra A, Matharu MS, Buchel C, Frackowiak RS, Goadsby PJ. Brainstem activation specific to migraine headache. Lancet. 2001 Mar 31;357(9261):1016-7. doi: 10.1016/s0140-6736(00)04250-1.

    PubMed 11293599

  • Afridi SK, Matharu MS, Lee L, Kaube H, Friston KJ, Frackowiak RS, Goadsby PJ. A PET study exploring the laterality of brainstem activation in migraine using glyceryl trinitrate. Brain. 2005 Apr;128(Pt 4):932-9. doi: 10.1093/brain/awh416. Epub 2005 Feb 10.

    PubMed 15705611

  • Afridi SK, Giffin NJ, Kaube H, Friston KJ, Ward NS, Frackowiak RS, Goadsby PJ. A positron emission tomographic study in spontaneous migraine. Arch Neurol. 2005 Aug;62(8):1270-5. doi: 10.1001/archneur.62.8.1270.

    PubMed 16087768

  • Denuelle M, Fabre N, Payoux P, Chollet F, Geraud G. Hypothalamic activation in spontaneous migraine attacks. Headache. 2007 Nov-Dec;47(10):1418-26. doi: 10.1111/j.1526-4610.2007.00776.x.

    PubMed 18052951

  • Goadsby PJ, Hargreaves R. Refractory migraine and chronic migraine: pathophysiological mechanisms. Headache. 2008 Oct;48(9):1399-405. doi: 10.1111/j.1526-4610.2008.01274.x.

    PubMed 19006557

  • Fumal A, Laureys S, Di Clemente L, Boly M, Bohotin V, Vandenheede M, Coppola G, Salmon E, Kupers R, Schoenen J. Orbitofrontal cortex involvement in chronic analgesic-overuse headache evolving from episodic migraine. Brain. 2006 Feb;129(Pt 2):543-50. doi: 10.1093/brain/awh691. Epub 2005 Dec 5.

    PubMed 16330505

  • Valet M, Sprenger T, Boecker H, Willoch F, Rummeny E, Conrad B, Erhard P, Tolle TR. Distraction modulates connectivity of the cingulo-frontal cortex and the midbrain during pain--an fMRI analysis. Pain. 2004 Jun;109(3):399-408. doi: 10.1016/j.pain.2004.02.033.

    PubMed 15157701

  • Rolke R, Baron R, Maier C, Tolle TR, Treede -DR, Beyer A, Binder A, Birbaumer N, Birklein F, Botefur IC, Braune S, Flor H, Huge V, Klug R, Landwehrmeyer GB, Magerl W, Maihofner C, Rolko C, Schaub C, Scherens A, Sprenger T, Valet M, Wasserka B. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain. 2006 Aug;123(3):231-243. doi: 10.1016/j.pain.2006.01.041. Epub 2006 May 11.

    PubMed 16697110

Questions about this trial

What is this clinical trial studying?

An observational study of Migraine and Chronic Migraine, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pattern of brain metabolism using positron emission tomography(PET). (time frame: Estimated to be approximately three years post baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01741246, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in