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

March 11, 2024 updated by: Thomas Jefferson University

Brush Allodynia in Patients With Episodic Migraine During an Acute Attack.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

28

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
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Jefferson Headache Center

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

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

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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). After each series of brushes the patient will be asked to rate the level of discomfort from "normal sensation" to "extremely painful or unpleasant" using a 100 mm visual analog scale (VAS).
allodynia assessed within 4 hours from onset of migraine head pain

Collaborators and Investigators

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

Sponsor

Thomas Jefferson University

Investigators

  • Principal Investigator: Abraham A Ashkenazi, M.D., Jefferson Headache Center

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

March 1, 2006

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

May 24, 2006

First Submitted That Met QC Criteria

May 24, 2006

First Posted (Estimated)

May 25, 2006

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EM-BA/AAA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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