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

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Jefferson Headache Center

Philadelphia, Pennsylvania, 19107, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention: We are testing for the presence of allodynia

Other

We are testing for the presence of abnormal sensation (allodynia) during a migraine attack.

Primary outcomes

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).

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

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

Important dates

Study start: 2006
Primary completion: 2006
Study completion: 2008
First posted: May 25, 2006
Registry last updated: Mar 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed