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

NCT01741246 | Completed

• 1 other identifier: 1107004
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine; Chronic Migraine

Keywords

Episodic migraine; Chronic migraine; Magnetic resonance imaging; Positron emission tomography

Outcome Measures

Primary Outcomes (2)

• 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.

  Estimated to be approximately three years post baseline

• 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

  Estimated to be approximately three years post baseline

Study Arms (3)

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).

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Allergan: collaborator

Study Sites (1)

UCSF

San Francisco, California, 94115 & 94158, United States

Location

Related Publications (26)

• 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.

  PMID: 12045727 BACKGROUND

• 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.

  PMID: 15613165 BACKGROUND

• 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.

  PMID: 18711108 BACKGROUND

• 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.

  PMID: 17004916 BACKGROUND

• 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.

  PMID: 11807151 BACKGROUND

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

  PMID: 18778577 BACKGROUND

• 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.

  PMID: 7585147 BACKGROUND

• 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.

  PMID: 11293599 BACKGROUND

• 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.

  PMID: 15705611 BACKGROUND

• 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.

  PMID: 16087768 BACKGROUND

• 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.

  PMID: 18052951 BACKGROUND

• 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.

  PMID: 19006557 BACKGROUND

• 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.

  PMID: 16330505 BACKGROUND

• 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.

  PMID: 15157701 BACKGROUND

• 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.

  PMID: 16697110 BACKGROUND

• Raichle ME, MacLeod AM, Snyder AZ, Powers WJ, Gusnard DA, Shulman GL. A default mode of brain function. Proc Natl Acad Sci U S A. 2001 Jan 16;98(2):676-82. doi: 10.1073/pnas.98.2.676.

  PMID: 11209064 BACKGROUND

• Greicius MD, Krasnow B, Reiss AL, Menon V. Functional connectivity in the resting brain: a network analysis of the default mode hypothesis. Proc Natl Acad Sci U S A. 2003 Jan 7;100(1):253-8. doi: 10.1073/pnas.0135058100. Epub 2002 Dec 27.

  PMID: 12506194 BACKGROUND

• Calhoun VD, Adali T, Stevens MC, Kiehl KA, Pekar JJ. Semi-blind ICA of fMRI: A method for utilizing hypothesis-derived time courses in a spatial ICA analysis. Neuroimage. 2005 Apr 1;25(2):527-38. doi: 10.1016/j.neuroimage.2004.12.012.

  PMID: 15784432 BACKGROUND

• Matharu MS, Bartsch T, Ward N, Frackowiak RS, Weiner R, Goadsby PJ. Central neuromodulation in chronic migraine patients with suboccipital stimulators: a PET study. Brain. 2004 Jan;127(Pt 1):220-30. doi: 10.1093/brain/awh022. Epub 2003 Nov 7.

  PMID: 14607792 BACKGROUND

• Sprenger T, Ruether KV, Boecker H, Valet M, Berthele A, Pfaffenrath V, Woller A, Tolle TR. Altered metabolism in frontal brain circuits in cluster headache. Cephalalgia. 2007 Sep;27(9):1033-42. doi: 10.1111/j.1468-2982.2007.01386.x. Epub 2007 Jul 30.

  PMID: 17666083 BACKGROUND

• Headache Classification Committee of The International Headache Society. The International Classification of Headache Disorders (second edition). Cephalalgia 2004;24(Suppl 1):1-160.

  BACKGROUND

• Frackowiak RS, Friston KJ. Functional neuroanatomy of the human brain: positron emission tomography--a new neuroanatomical technique. J Anat. 1994 Apr;184 ( Pt 2)(Pt 2):211-25.

  PMID: 8014115 BACKGROUND

• Talairach J, Tournoux P. Coplanar Stereotaxic Atlas of the Human Brain. New York: Thieme; 1988.

  BACKGROUND

• Valk PE, Delbeke D, Bailey DL, D.W. T, Maisey MN. Positron Emission Tomography: Springer; 2006.

  BACKGROUND

• 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.

  BACKGROUND

• Headache Classification Committee; Olesen J, Bousser MG, Diener HC, Dodick D, First M, Goadsby PJ, Gobel H, Lainez MJ, Lance JW, Lipton RB, Nappi G, Sakai F, Schoenen J, Silberstein SD, Steiner TJ. New appendix criteria open for a broader concept of chronic migraine. Cephalalgia. 2006 Jun;26(6):742-6. doi: 10.1111/j.1468-2982.2006.01172.x.

  PMID: 16686915 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2012
• First Posted: December 4, 2012
• Study Start: September 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: June 30, 2015

Record last verified: 2015-06

Locations

US (1)