Neuromodulation Treatment of Vestibular Migraines

Study Overview
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Brief Summary
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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.

Detailed Description
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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 Reduction in the frequency and severity of migraine headaches (self reported in pain diary) 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 Improvement in sleep quality and/or quantity as assessed by the Epworth Sleep Scale. Improvement in quality of life as assessed by the HIT-6 survey. Improvement in mood/anxiety as assessed with the T2 Mood Tracker app (National Center for Telehealth & Technology).

Official Title
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Neuromodulation Treatment of Vestibular Migraines

Conditions
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Headache

Intervention / Treatment
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* Device: Device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults, between the ages of 18 and 75 who have been diagnosed with VM least 3 months prior to entering into the study. 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: are pregnant have a history of cardiovascular disease work night shifts have a history of unstable mood disorder or unstable anxiety disorder use a hearing aid have a cochlear implant abuse alcohol or other drugs 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). have had eye surgery within the previous three months or ear surgery within the previous six months have active ear infections or a perforated tympanic membrane have participated in another clinical trial within the last 30 days or are currently enrolled in another clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device<br>Neuromodulation | Device: Device<br>* The following parameters will be set for active treatments using the CVS Device: A standardized CVS time-varying waveform lasting approximately 19 minutes will be used. Treatments will be administered up to twice daily. The two daily treatments should ideally be separated by at least one hour. The waveform schedule will consist of a warm sawtooth delivered to one ear and a cold sawtooth delivered to the other ear. The warm sawtooth will go from body temperature to 42 °C, and the cold sawtooth will go from body temperature to 17 °C. The two waveforms will be delivered simultaneously, but will have different oscillation frequencies.<br>* Other names: Caloric stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dizziness Handicap Inventory | Questionnaire of dizziness symptoms | Until study completion up to 12 months | 
| Headache Impact Test | Headache questionnaire | Until study completion up to 12 months | 
| Activities Balance Confidence Interval | Dizziness questionnaire | Until study completion up to 12 months | 
| OVRT Testing | Oculomotor, vestibular, and reaction time tests | Until study completion up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epworth Sleepiness Scale | Sleepiness questionnaire | Until study completion up to 12 months | 
| T2 Mood Tracker app | App to assess mood and anxiety | Until study completion up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vestibular migraines, dizziness, migraine headache