Neuromodulation Treatment of Vestibular Migraines

This is a non-blinded, non-randomized pilot study of individuals with vestibular migraines.
The goal is to test the efficacy of neuromodulation on both migraine and dizziness symptoms
in patients with documented vestibular migraines. Treatment will consist of 9 months of
active treatment followed by 3 months of observation. The active treatment requires two daily
20 minute sessions wearing a device over the ears that delivers a very small amount of warm
air to the ears. All subjects will undergo a series of tests at baseline and at discrete
intervals during the 1 year of observation.

Primary and Secondary endpoints are listed below:• Primary Efficacy Endpoints

1. Reduction in the frequency and severity of migraine headaches (self reported in pain
diary)

2. Reduction in the frequency and intensity of perceived vestibular symptoms (Dizziness
Handicap Inventory (DHI), Activity Balance confidence scale (ABC), Oscillopsia Test,
Symptoms questionnaire), OVRT Goggle profile.

Secondary Efficacy Endpoints for the Pilot Study

1. Improvement in sleep quality and/or quantity as assessed by the Epworth Sleep Scale.

2. Improvement in quality of life as assessed by the HIT-6 survey.

3. Improvement in mood/anxiety as assessed with the T2 Mood Tracker app (National Center
for Telehealth & Technology).

Inclusion Criteria:

1. Adults, between the ages of 18 and 75 who have been diagnosed with VM least 3 months
prior to entering into the study.

2. The Investigator must have confidence in the patient's ability to reliably use the CVS
Device and complete the requirements of the study.

Exclusion Criteria:

1. are pregnant

2. have a history of cardiovascular disease

3. work night shifts

4. have a history of unstable mood disorder or unstable anxiety disorder

5. use a hearing aid

6. have a cochlear implant

7. abuse alcohol or other drugs

8. are experiencing Medication Overuse Headaches (individuals with respect to whom the
Investigator is concerned that analgesic abuse is involved based on the ICHD-II
guidelines).

9. have had eye surgery within the previous three months or ear surgery within the
previous six months

10. have active ear infections or a perforated tympanic membrane

11. have participated in another clinical trial within the last 30 days or are currently
enrolled in another clinical trial