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

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01080287
• Other study ID #: 08-778
• Status: Completed
• Phase: N/A
• First received: March 2, 2010
• Last updated: February 20, 2012
• Start date: September 2009
• Est. completion date: September 2011

Study information

• Verified date: February 2012
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Autonomic Nervous System Diseases
• Migraine
• Primary Dysautonomias

Locations

Country	Name	City	State
United States	Cleveland Clinic NI, Center for Headache and Pain, Desk T-33, 9500 Euclid Avenue	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

References & Publications (4)

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

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. — View Citation

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. — View Citation