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

Completed

• Conditions: Migraine

• Registration Number: NCT00329771
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-05-24
• Study First Submitted QC: 2006-05-24
• Study First Posted: 2006-05-25
• Primary Completion: 2006-12
• Study Completion: 2008-03
• Results First Submitted: 2014-03-04
• Results First Submitted QC: 2014-03-14
• Results First Posted: 2014-04-21
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects With Allodynia During a Migraine Attack	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).

Trial Locations

Locations (1)

Jefferson Headache Center; 🇺🇸 Philadelphia, Pennsylvania, United States