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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).
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
Yes
University of Miami Miller School of Medicine
Miami, Florida, United States
Start Date
September 28, 2016
Primary Completion Date
May 1, 2019
Completion Date
May 1, 2019
Last Updated
May 29, 2019
Device
DEVICE
Lead Sponsor
University of Miami
Collaborators
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT07476053