Research Study to Determine Sensitivity to Gentle Touch and Pressure During an Active Migraine Attack.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00329771
Recruitment Status : Completed
First Posted : May 25, 2006
Results First Posted : April 21, 2014
Last Update Posted : April 21, 2014
Information provided by (Responsible Party):
Thomas Jefferson University

Brief Summary:
Cutaneous allodynia (pronounced q-tane-ee-us all-o-din-ee-a) is common in migraine. It is a heightened skin sensitivity during an active migraine attack. Migraine attacks in patients who experience allodynia are more difficult to treat. This study intends to collect and evaluate data on the phenomenon of allodynia in patients with episodic migraine during an actual attack. The results of this study may help clinicians better understand allodynia, thereby helping them diagnose and more effectively manage patients with migraine and allodynia.

Condition or disease Intervention/treatment
Migraine Other: No intervention: We are testing for the presence of allodynia

Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Brush Allodynia in Patients With Episodic Migraine During an Acute Attack.
Study Start Date : March 2006
Actual Primary Completion Date : December 2006
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Group/Cohort Intervention/treatment
Episodic migraineurs
Eligible subjects with episodic migraine (with or without aura)
Other: No intervention: We are testing for the presence of allodynia
We are testing for the presence of abnormal sensation (allodynia) during a migraine attack.

Primary Outcome Measures :
  1. Proportion of Subjects With Allodynia During a Migraine Attack [ Time Frame: allodynia assessed within 4 hours from onset of migraine head pain ]
    Brush allodynia (discomfort with normal sensation) measured at pre-specified sites on the head, neck and forearms using a 100 mm visual analog scale (VAS).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with episodic migraine, as defined by the International Headache Society,recruited from our office practice and the communitiy

Inclusion Criteria:

  • Male and female patients aged 18-65, inclusive
  • Diagnosis of episodic migraine with or without aura.
  • Ability to read and understand an informed consent form and study procedures

Exclusion Criteria:

  • Patients with abnormal sensory findings on examination, or any known neurological disease that may affect skin sensation (peripheral neuropathy, multiple sclerosis, stroke, etc).
  • Patients who suffer from headache (of any type) 15 or more days per month
  • Patients who are cognitively impaired, as determined by investigator
  • Patients with significant psychiatric disorder that may affect their understanding of the study protocol and/or their cooperation with the investigators.
  • Patients who had taken any acute pain medication (e.g. triptans, ergots, NSAIDs, opioids, butalbital, acetaminophen) for any indication within 12 hours prior to allodynia testing.
  • Patients with skin diseases that may cause abnormal skin sensation.
  • Patients who had been treated with a nerve block in the 4 week period prior to allodynia testing Patients who had been treated with Botulinum neurotoxin within the 4 month period prior to allodynia testing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00329771

United States, Pennsylvania
Jefferson Headache Center
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Principal Investigator: Abraham A Ashkenazi, M.D. Jefferson Headache Center

Responsible Party: Thomas Jefferson University Identifier: NCT00329771     History of Changes
Other Study ID Numbers: EM-BA/AAA
First Posted: May 25, 2006    Key Record Dates
Results First Posted: April 21, 2014
Last Update Posted: April 21, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases