Headache Clinical Trial
Official title:
Neuromodulation Treatment of Vestibular Migraines
This is a non-randomized pilot study to test the efficacy of neuromodulation via caloric stimulation on vestibular migraines. All subject who meet the study criteria will be in an active treatment group. All subjects will report the frequency of the migraines and undergo periodic testing of symptoms.
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).
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