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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01080287
First received: March 2, 2010
Last updated: February 20, 2012
Last verified: February 2012
History of Changes
  Purpose

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).

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:

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:

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 22, 2013