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

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01741246
• Other study ID #: 1107004
• Status: Completed
• Phase: N/A
• First received: November 26, 2012
• Last updated: June 26, 2015
• Start date: September 2011
• Est. completion date: June 2015

Study information

• Verified date: June 2015
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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. Such structures include the brainstem, hypothalamus, and orbitofrontal cortex and can be defined using functional brain imaging.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Migraine
• Migraine
• Migraine Disorders

Locations

Country	Name	City	State
United States	UCSF	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Allergan

Country where clinical trial is conducted

United States, 

References & Publications (26)

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Afridi SK, Goadsby PJ. Neuroimaging of migraine. Curr Pain Headache Rep. 2006 Jun;10(3):221-4. Review. — View Citation

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. Epub 2005 Feb 10. — View Citation

Bahra A, Matharu MS, Buchel C, Frackowiak RS, Goadsby PJ. Brainstem activation specific to migraine headache. Lancet. 2001 Mar 31;357(9261):1016-7. — View Citation

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. Review. — View Citation

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. — View Citation

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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. Epub 2005 Dec 5. — View Citation

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Goadsby PJ, Lipton RB, Ferrari MD. Migraine--current understanding and treatment. N Engl J Med. 2002 Jan 24;346(4):257-70. Review. — View Citation

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Headache Classification Committee, Olesen J, Bousser MG, Diener HC, Dodick D, First M, Goadsby PJ, Göbel 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. — View Citation

Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders: 2nd edition. Cephalalgia. 2004;24 Suppl 1:9-160. — View Citation

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. Epub 2003 Nov 7. — View Citation

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Rolke R, Baron R, Maier C, Tölle TR, Treede RD, Beyer A, Binder A, Birbaumer N, Birklein F, Bötefür IC, Braune S, Flor H, Huge V, Klug R, Landwehrmeyer GB, Magerl W, Maihöfner 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):231-43. Epub 2006 May 11. Erratum in: Pain. 2006 Nov;125(1-2):197. — View Citation

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Sprenger T, Ruether KV, Boecker H, Valet M, Berthele A, Pfaffenrath V, Wöller A, Tölle TR. Altered metabolism in frontal brain circuits in cluster headache. Cephalalgia. 2007 Sep;27(9):1033-42. Epub 2007 Jul 30. — View Citation

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.

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Welch KM, Goadsby PJ. Chronic daily headache: nosology and pathophysiology. Curr Opin Neurol. 2002 Jun;15(3):287-95. Review. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No