Abortive Effect of an Ear Insufflator on Migraine

Each patient will be asked (using a questionnaire) to describe the nature of their
presenting symptoms including distribution pattern, symmetry, laterality, severity and
associated symptoms. Severity of migraine/headache will be recorded. The patient's
description of their symptoms will be used to guide the treatment process in terms of
treatment time and side (i.e. left or right ear). A tubular soft silicone ear-plug will be
inserted into the patient's ear on the side of greatest reported severity. In the absence of
clear laterality with respect to severity, the side associated with the greatest surface
area of involvement will be selected (e.g., the patient has a bilateral headache but on the
left, it is perceived as retro-orbital whereas on the right it is retro-orbital and
temporal, therefore the right side will be selected), In the absence of lateralizing
features, the initial treatment side will be randomly selected. Then the air insufflation
will start. The patient will be encouraged to relax during the process and the extent of the
insufflation will be maintained a level that is comfortable for the patient. The patient
will be asked to report any sense of aggravation of their symptoms, which would prompt the
examiner to suspend the treatment. The patient will not know if the treatment received is
the active or the placebo one.

Following insufflation, the ear plug will be removed and the patient will be asked to rate
the severity of their symptoms and describe any changes in characteristics. A significant
reduction in pain level will be considered an indication that the treatment is appropriate
for that patient and the treatment will then continue on the ipsilateral side. If the
patients will describe resolution of their symptoms in a hemi-distribution of the head ("the
symptoms are gone from this side of my head but they're still left on the other side"), the
treatment process will be repeated on the contralateral side until resolution (or maximal
reduction in symptoms) will be achieved. Treatment session in this study will last 20
minutes.

There will be a followup at 2h and 24h post treatment to monitor the status of the patient
and they will all be invited back for a second treatmentduring the subsequent episode of
migraine.

Vitals (blood pressure, heart rate, pulse oxygenation and temperature) will also be
monitored to see if there are any changes before and immediately after treatment.

Inclusion Criteria:

- Adult subjects suffering from acute migraine episodes

- Possibly located in the Phoenix, AZ area

Exclusion Criteria:

- Pregnant/nursing women