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

Study Overview
=================
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.

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

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Other: No intervention: We are testing for the presence of allodynia


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Episodic migraineurs<br>Eligible subjects with episodic migraine (with or without aura) | Other: No intervention: We are testing for the presence of allodynia<br>* We are testing for the presence of abnormal sensation (allodynia) during a migraine attack.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | allodynia assessed within 4 hours from onset of migraine head pain |