Efficacy of a Transcranial Vibrating System for Mitigation of Migraine Associated Vertigo

Vertigo is among the most common symptoms associated with migraine and affects 26.5% of
migraine sufferers. Migraine Associated Vertigo (MAV) has a dramatic impact on daily life,
impacting work, relationships, and even activities of daily living. At the current time, the
mainstay of therapy for migraine is pharmaceutical intervention, either acute (particularly
triptans, 2) or preventative. However, this therapy has a delayed effect and can lead to a
host of side effects.

In this project we examine a device that has shown promise and might be beneficial for
treating or improving the course of recovery from MAV. The Otoband is a transcranial
vibrating system to be placed against the skull, preferably over the mastoid bone, behind the
ear. To date, the device has only been systematically tested on healthy volunteers and has
shown improvement of vertigo symptoms during the use of virtual reality systems and road
motion sickness.

Individuals identified at Jefferson University medical center with a history of MAV attacks
will be referred to the Otolaryngology Department where their diagnosis will be confirmed and
offered to enroll in the study. Participants will be able to take home an Otoband to wear
when they have MAV attacks. The Otoband will be set at the effective power (proved to reduce
vertigo symptoms in previous studies) and low power (proved to not impact vertigo symptoms,
considered as sham device). Participants will have to assay their vertigo symptoms before,
during and immediately after wearing the Otoband to evaluate the efficacy of the device.

Inclusion Criteria:

Subject between the ages of 18-65 with a history of frequent Migraine Associated Vertigo
(MAV) attacks as characterized by the following:

- An episode with acute onset vertigo that lasted at least 15 minutes within the
previous 30 days.

- At least 5 such episodes in the past 12 months.

Exclusion Criteria:

1. History of head injury within the last six months or currently suffering the effects
of a head injury

2. Presence of severe aphasia

3. History of diagnosed neuropsychiatric disorders (e.g. hypochondriasis, major
depression, schizophrenia)

4. Documented neurodegenerative disorders

5. Pregnancy [Female candidates will be asked if they are pregnant]

6. Prior disorders of hearing and balance including:

1. Ménière's disease

2. Multiple sclerosis

3. Vestibular neuritis

4. Vestibular schwannoma

5. Sudden sensorineural hearing loss

7. History of Cerebrovascular disorders

8. History of ear operation other than myringotomy and tube placement in the past

9. Planned major surgery of the skull base (for instance, cochlear implant)

10. Systemic disorders to include chronic renal failure, cirrhosis of the liver,
autoimmune disease, heart disease, lung disease, or severe arthritis

11. Individuals who cannot provide informed consent