Electrical Vestibular Stimulation: Subthreshold 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: Identical 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.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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.
* Physical ability to stand unassisted for at least one minute and walk 25 feet without assistance.
Exclusion Criteria:
* 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.
* Use of vestibular suppressant or migraine prophylactic medications that cannot be paused or maintained at a stable dose during the two-week EVS intervention period. Acute use of rescue medications during a severe attack is permitted, however, participants who initiate new medication or undergo dose changes during the intervention window will be excluded from final analysis.
* Current medical, psychiatric, or neurological condition (other than VM) that could interfere with participation.
* Cognitive or language impairments that preclude understanding of instructions or valid completion of outcome measures.
Primary outcome measure(s)
Change in Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM PATHI) score — Baseline (pre intervention) to one month after completion of the two week EVS/sham intervention. 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) — From first stimulation session to end of the two week intervention period 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 — 30 days prior to first stimulation session through 30 days after the final stimulation session (total 60 days) 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) — From baseline visit through one month post intervention follow up. 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.
Trial sites (1)
Facility
City
Region
Status
Human Performance Laboratory, University of Calgary
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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