SENSE-VM: Safety and Effectiveness of a Novel Medical Device for Symptom Ease in Vestibular Migraines
Abstract
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.
Conditions: Vestibular Migraine, Migraine Associated Vertigo.
Primary outcome: DHI Change in Scores.
Enrollment: 322 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 322 participants or records.
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