Vestibular migraine is a common cause of repeated dizziness, imbalance, and headaches that affects about three percent of Canadians. Many people do not find relief from current medications, leaving them with long term problems in balance and daily function. This study will test a new, non drug based treatment called electrical vestibular stimulation (EVS). EVS delivers gentle, safe electrical signals behind the ears to activate the brain's vestibular pathways.
Fifty adults with vestibular migraine will take part. Half will receive real stimulation, and half will receive a sham (placebo) treatment. Each participant will attend six sessions over two weeks. Around the treatment period, they will record dizziness and migraine symptoms in a daily diary and complete questionnaires and balance tests using motion sensors.
The main goal is to determine whether EVS can be delivered safely and comfortably in adults with vestibular migraine and whether participants can complete the sessions and assessments as planned. Results will also show whether symptoms or balance improve, providing essential information to design a larger clinical trial and, ultimately, develop new, accessible treatments for dizziness and migraine.
Clinical diagnosis of VM, according to the ICHD-3 and Barany Society criteria.
Experienced at least one vestibular migraine episode in the previous month.
Ability to provide informed consent and comply with study requirements.
Willingness to attend six EVS sessions over a two-week period and complete all required testing and diaries.
Diagnosis of other vestibular disorders (e.g. benign paroxysmal positional vertigo, Meniere's disease, vestibular neuritis) that may confound results.
History of seizure disorder, epilepsy, or unexplained loss of consciousness.
Presence of implanted electronic medical devices, such as pacemakers or cochlear implants.
Pregnancy or plans to become pregnant during study period.
Parallel
Electrical Vestibular Stimulation
DeviceSubthreshold stochastic electrical vestibular stimulation delivered with a dual-channel isolated constant-current stimulator (Neursantys Inc.). Four-electrode mastoid-C4 montage; wideband stochastic current (0.001-300 Hz), ±0.35 mA (0.70 mA peak-to-peak), output sampled at 5 kHz. Two 20-minute seated stimulation blocks per session. Generates vestibular afferent activation while remaining below perceptual thresholds.
Electrical Vestibular Stimulation Sham
DeviceIdentical electrode placement and device setup as active electrical vestibular stimulation. Device ramps briefly, then delivers zero current for the remainder of the two 20-minute blocks. Device lights remain active to maintain masking; no vestibular stimulation is delivered after the ramp.
Change in Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM PATHI) score
The VM PATHI is a validated questionnaire specific to vestibular migraine that assesses six categories of patient reported outcome measures. It is a 25-item questionnaire scoring from 0 (best) - 100 (worst). The primary efficacy analysis will compare change in VM PATHI total score from baseline to one month post intervention between the active stimulation and sham groups using linear mixed effects models adjusted for baseline score, age, and sex.
Session Adherence (feasibility of delivering six Stim/Sham sessions)
Proportion of randomized participants who complete at least five of six planned electrical vestibular stimulation or sham sessions within 14 days. Feasibility will be considered acceptable if at least 80 percent of participants meet this criterion.
Diary completion rate
Proportion of days with a completed daily vertigo/migraine symptom diary during the 60 day monitoring period. Feasibility will be evaluated by the percentage of participants who complete diaries on at least 80 percent of days.
EVS related adverse events (safety and tolerability)
Number and severity of device related adverse events, including skin irritation, discomfort, headache worsening, or other unexpected symptoms, recorded at each visit using a standardized adverse event log. Events will be summarized as counts and proportions per group and classified by seriousness and relatedness to the study device.
Change in Dizziness Handicap Inventory (DHI) score
The DHI is a 25 item questionnaire assessing self perceived handicap due to dizziness. Total scores (0-100) will be compared across time and between active and sham groups to evaluate changes in dizziness related disability.
Change in Activities specific Balance Confidence (ABC) scale score
The ABC scale is a 16-item questionnaire that assesses confidence in maintaining balance during daily activities. Percentage scores (0-100 percent) will be used to assess changes in balance confidence over time and between groups.
Change in Migraine Disability Assessment (MIDAS) scores
The MIDAS is a 5-item questionnaire that captures frequency of headaches that affect certain tasks over 3-months. Scores are tallied from 0 (best) to 21+ (worst), indicating severe disability. Scores will be compared between active and sham groups to estimate the effect of electrical vestibular stimulation on migraine related disability.
Change in Motion Sickness Susceptibility Questionnaire (MSSQ) scores
The MSSQ is an 18-item questionnaire that assesses susceptibility to motion sickness from 0 (best) to 54 (best). Changes in this score will be compared between stimulation and sham groups.
Menstrual cycle phase tracking
Among menstruating participants, daily diary entries will record menstrual bleeding. Exploratory analyses will examine whether changes in primary outcomes differ by menstrual cycle phase (bleeding vs non bleeding days).
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University of Calgary
Lead sponsor
Neursantys Inc
Collaborator
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