Exploring Mild Electrical Vestibular Stimulation as a New Treatment for Dizziness and Migraine Symptoms

NCT07368140 | Not Yet Recruiting

• 1 other identifier: REB25-1327
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vestibular Migraine

Keywords

Electrical Vestibular Stimulation; Galvanic Vestibular Stimulation; Vestibular Migraine; Vertigo; Dizziness; Balance and gait; Inertial Measurement Units; Motion sensitivity; Posturography; Neuromodulation

Outcome Measures

Primary Outcomes (4)

• 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.

  Baseline (pre intervention) to one month after completion of the two week EVS/sham intervention.

• 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.

  From first stimulation session to end of the two week intervention period

• 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.

  30 days prior to first stimulation session through 30 days after the final stimulation session (total 60 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.

  From baseline visit through one month post intervention follow up.

Secondary Outcomes (10)

• Change in Dizziness Handicap Inventory (DHI) score

  Baseline, immediately post intervention, and one month post intervention

• Change in Activities specific Balance Confidence (ABC) scale score

  Baseline, immediately post intervention, and one month post intervention

• Change in Migraine Disability Assessment (MIDAS) scores

  Baseline and one month post intervention

• Change in Motion Sickness Susceptibility Questionnaire (MSSQ) scores

  Baseline and one month post intervention

• Change in Vestibular Ocular Motor Screening (VOMS) symptom provocation scores

  Baseline and immediately post intervention

Other Outcomes (1)

• Menstrual cycle phase tracking

  Daily menstrual tracking for 30 days before and 30 days after the intervention

Study Arms (2)

Active subthreshold stochastic electrical vestibular stimulation

EXPERIMENTAL

Participants randomized to the active arm will receive subthreshold wideband stochastic electrical vestibular stimulation delivered via surface electrodes placed over the mastoid region and upper neck. Stimulation will be administered while seated in six sessions over two weeks. Each session will consist of two 20 minute stimulation blocks separated by a 5 minute rest. The current waveform will be a low amplitude stochastic signal (±0.35 mA) adjusted to remain below the threshold for overt vestibular sensations while providing continuous vestibular afferent input. Participants will be free to rest, read, or use personal devices during stimulation.

Device: Electrical Vestibular Stimulation

Sham electrical vestibular stimulation

SHAM COMPARATOR

Participants randomized to the sham arm will undergo identical preparation, electrode placement, and scheduling as the active group, including six seated sessions over two weeks with two 20 minute blocks and a 5 minute rest per session. At the start of each block, the stimulator will briefly ramp up to a low current to mimic the sensation of active stimulation, then be reduced to zero current for the remainder of the session, while device indicators remain active. No therapeutic level vestibular stimulation will be delivered.

Device: Electrical Vestibular Stimulation Sham

Interventions

Electrical Vestibular Stimulation DEVICE

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.

Also known as: Galvanic Vestibular Stimulation

Active subthreshold stochastic electrical vestibular stimulation

Electrical Vestibular Stimulation Sham DEVICE

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.

Sham electrical vestibular stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Calgary: lead
• Neursantys Inc: collaborator

Study Sites (1)

Human Performance Laboratory, University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

MeSH Terms

Conditions

Vertigo; Dizziness

Condition Hierarchy (Ancestors)

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sensation Disorders

Central Study Contacts

Ryan Peters, Ph.D.

CONTACT

403-220-7810; ryan.peters1@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm, 1:1 randomized, parallel group design comparing active subthreshold stochastic electrical vestibular stimulation (EVS) to sham EVS, delivered across 6 sessions over 2 weeks, with symptom diaries and sensor-based balance and gait assessments.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: January 26, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: January 26, 2026

Record last verified: 2025-10

Locations

CA (1)