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

Migraine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00329771
• Other study ID #: EM-BA/AAA
• Status: Completed
• Start date: March 2006
• Est. completion date: March 2008

Study information

• Verified date: March 2024
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 2008
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Jefferson Headache Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Subjects With Allodynia During a Migraine Attack	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