SENSE-VM: Safety and Effectiveness of a Novel Medical Device for Symptom Ease in Vestibular Migraines
Status: Not yet recruiting

The goal of this virtual clinical trial is to compare the effectiveness of two study devices in providing temporary relief to adults aged 18-75 who suffer from symptoms of chronic Vestibular Migraines (VM), also known as Migraine Associated Vertigo.

Participants will be:

Enrolled up to 50 days; enrollment, 14 days in Baseline Phase (no device), 7 days in Transition Phase, 28 days in Treatment Phase (study device)
Randomized and stratified into groups based on the referring clinic to be assigned one study device
Asked to use the study device as instructed by the study coordinator
Asked to submit daily diaries reporting their symptoms and use of device, and to participate in tele-health visits with study coordinators
Asked to provide their vertigo diagnosis from their physician
Compensated for their participation

Researchers will compare the randomized groups to determine which group responds better to which device.

Eligibility:
- EligibilityCriteria: Inclusion Criteria:  To be eligible to participate in this study, an individual must meet all the following criteria:  - Diagnosed as having Vestibular Migraine (VM) (aka Migraine Associated Vertigo) The participant's diagnosis must be provided by a physician, Board certified in Otolaryngology or Neurology, from one of the study's approved clinics.  Diagnosis for VM must follow Bárány Society's "International Classification of Vestibular Disorders", which contains the Society's consensus diagnostic criteria for VM [Lempert 2022, sect. 3].  Male or female subjects, age 18 to 75 years old inclusive on day of enrollment Residing in the United States Vestibular migraines that have been recurrent for at least 90 days Score from 36 to 90 inclusive on the Dizziness Handicap Inventory (DHI) (corresponding to moderate to severe vertigo) A smartphone, computer or tablet and access to internet to complete study procedures and study meetings Willing and able to comply with study procedures Willingness to use Venmo or Paypal for study stipend  Exclusion Criteria:  Females who are pregnant or trying to become pregnant Enrolled in previous Otolith Lab-sponsored clinical trial Currently taking part in another interventional trial Surgery to the skull base within the last 6 months or plans for surgery to the skull during enrollment period Skull or neck implants History of vitreous detachment in the last 90 days Superior canal dehiscence or otic capsule dehiscence Diagnosed hyperacusis Undergoing vestibular rehabilitation therapy or planning to start vestibular rehabilitation therapy during the study History of cerebrovascular disorders Posterior fossa tumors, vestibular schwannoma Cerebellar degeneration (progressive worsening of neurons behind the brain stem) Taking benzodiazepines (e.g., clonazepam, lorazepam, diazepam) Initiation of calcitonin gene-related peptide inhibitor treatment within 4 weeks prior to beginning of trial Cognitive impairment or inability to follow study procedures - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - MaximumAge: 75 Years - StdAgeList: Adult, Older Adult