The Identification and Characterization of Autonomic Dysfunction in Migraineurs With and Without Auras

NCT ID: NCT01080287

Last Updated: 2012-02-22

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-09-30

Brief Summary

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This is a study to compare subject response and symptoms resulting from administration of three clinical assessments.

\* 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).

Detailed Description

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Conditions

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Migraine

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

* age 18 to 65
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cleveland Clinic NI, Center for Headache and Pain, Desk T-33, 9500 Euclid Avenue

Cleveland, Ohio, United States

Site Status

Countries

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United States

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.

Reference Type BACKGROUND
PMID: 7746369 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3511818 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7477980 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14979299 (View on PubMed)

Other Identifiers

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08-778

Identifier Type: -

Identifier Source: org_study_id

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