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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00329771
First received: May 24, 2006
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

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 Intervention
Migraine
Other: No intervention: We are testing for the presence of allodynia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Brush Allodynia in Patients With Episodic Migraine During an Acute Attack.

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Proportion of Subjects With Allodynia During a Migraine Attack [ Time Frame: allodynia assessed within 4 hours from onset of migraine head pain ] [ Designated as safety issue: No ]
    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).


Enrollment: 28
Study Start Date: March 2006
Study Completion Date: March 2008
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  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

Subjects with episodic migraine, as defined by the International Headache Society,recruited from our office practice and the communitiy

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329771

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

No publications provided

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00329771     History of Changes
Other Study ID Numbers: EM-BA/AAA
Study First Received: May 24, 2006
Results First Received: March 4, 2014
Last Updated: March 14, 2014
Health Authority: United States: Institutional Review Board

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 July 24, 2014