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

This study has been completed.

First Received on March 2, 2010. Last Updated on February 20, 2012 History of Changes

Sponsor:	The Cleveland Clinic
Information provided by (Responsible Party):	The Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT01080287

Purpose

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

* The 3 assessments are

passive upright tilt table testing,
quantitative sudomotor axon reflex testing (QSART)and
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).

Condition
Migraine

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	The Identification and Characterization of Autonomic Dysfunction in Migraineurs With and Without Auras

Resource links provided by NLM:

MedlinePlus related topics: Fainting Migraine Mitral Valve Prolapse

U.S. FDA Resources

Further study details as provided by The Cleveland Clinic:

Enrollment:	60
Study Start Date:	September 2009
Study Completion Date:	September 2011
Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
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
Migraineurs with or without auras Subjects between ages 18 and 65 having ICHD-II classification of migraine with or without auras

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Adult Migraineurs with and without auras, half having orthostatic intolerance.

Criteria

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

Exclusion Criteria:

subjects who do not meet inclusion criteria
subjects unable to complete informed consent process

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01080287

Locations

United States, Ohio
Cleveland Clinic NI, Center for Headache and Pain, Desk T-33, 9500 Euclid Avenue
Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

The Cleveland Clinic

More Information

Publications:

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. Review.

Fouad FM, Tadena-Thome L, Bravo EL, Tarazi RC. Idiopathic hypovolemia. Ann Intern Med. 1986 Mar;104(3):298-303.

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.

Headache Classification Subcommittee of the International Headache Society. The International Classification of Headache Disorders: 2nd edition. Cephalalgia. 2004;24 Suppl 1:9-160. No abstract available.

Responsible Party:	The Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT01080287 History of Changes
Other Study ID Numbers:	08-778
Study First Received:	March 2, 2010
Last Updated:	February 20, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:

autonomic
orthostatic
syncope

biopsy
prevalence of autonomic dysfunction in migraineurs with orthostatic intolerance
characterize autonomic findings utilizing neurocardiac testing, neurophysiological testing and skin biopsies to analyze autonomic fibers in the dermis

Additional relevant MeSH terms:

Migraine Disorders
Headache Disorders, Primary
Headache Disorders

Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 24, 2012