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

February 20, 2012 updated by: The Cleveland Clinic

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).

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

March 2, 2010

First Submitted That Met QC Criteria

March 3, 2010

First Posted (Estimate)

March 4, 2010

Study Record Updates

Last Update Posted (Estimate)

February 22, 2012

Last Update Submitted That Met QC Criteria

February 20, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-778

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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