The Identification and Characterization of Autonomic Dysfunction in Migraineurs With and Without Auras
NCT ID: NCT01080287
Last Updated: 2012-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2009-09-30
2011-09-30
Brief Summary
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\* The 3 assessments are
1. passive upright tilt table testing,
2. quantitative sudomotor axon reflex testing (QSART)and
3. punch biopsy.
The comparison of results will be from two subject groups:
* Group A, the migraine suffering patient with or without aura
* Group B, the migraine suffering patient with or without aura who has diagnosed orthostatic intolerance (i.e.,feeling dizzy or faint when making a body position change).
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Migraineurs with & w/out auras having orthostatic intolerance
Subjects between ages 18 and 65, having ICHD-II classification of migraine with or without aura, having symptoms of orthostatic intolerance
No interventions assigned to this group
Migraineurs with or without auras
Subjects between ages 18 and 65 having ICHD-II classification of migraine with or without auras
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* male or female
* migraine diagnosis
* may or may not have orthostatic intolerance
* able to demonstrate study understanding and complete informed consent process
* subjects unable to complete informed consent process
18 Years
65 Years
ALL
No
Sponsors
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The Cleveland Clinic
OTHER
Responsible Party
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Locations
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Cleveland Clinic NI, Center for Headache and Pain, Desk T-33, 9500 Euclid Avenue
Cleveland, Ohio, United States
Countries
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References
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Low PA, Opfer-Gehrking TL, Textor SC, Benarroch EE, Shen WK, Schondorf R, Suarez GA, Rummans TA. Postural tachycardia syndrome (POTS). Neurology. 1995 Apr;45(4 Suppl 5):S19-25.
Fouad FM, Tadena-Thome L, Bravo EL, Tarazi RC. Idiopathic hypovolemia. Ann Intern Med. 1986 Mar;104(3):298-303. doi: 10.7326/0003-4819-104-3-298.
McCarthy BG, Hsieh ST, Stocks A, Hauer P, Macko C, Cornblath DR, Griffin JW, McArthur JC. Cutaneous innervation in sensory neuropathies: evaluation by skin biopsy. Neurology. 1995 Oct;45(10):1848-55. doi: 10.1212/wnl.45.10.1848.
Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders: 2nd edition. Cephalalgia. 2004;24 Suppl 1:9-160. doi: 10.1111/j.1468-2982.2003.00824.x. No abstract available.
Other Identifiers
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08-778
Identifier Type: -
Identifier Source: org_study_id
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