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

University of Calgary

Status: Not yet enrolling

Conditions: Vestibular Migraine

Treatments: Device: Electrical Vestibular Stimulation Sham; Device: Electrical Vestibular Stimulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07368140

REB25-1327

Details and patient eligibility

About

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.

Full description

Vestibular migraine (VM) is a neurological disorder in which recurrent vestibular symptoms such as vertigo, dizziness, and imbalance occur in association with migraine features. VM can produce persistent motion sensitivity, activity restriction, and functional impairment, and many individuals report incomplete relief of dizziness or imbalance with current pharmacologic strategies. Proposed mechanisms implicate altered multisensory integration across vestibular and migraine-related nociceptive networks, including abnormal brainstem and thalamocortical processing, trigeminal vestibular interactions, neuropeptide mediated neuroinflammation, cortical spreading depression, and central sensitization. These features motivate evaluation of non drug neuromodulation approaches that target vestibular pathway excitability and integration.

Electrical vestibular stimulation (EVS) is a non invasive neuromodulation technique that applies low amplitude electrical current through surface electrodes positioned over the mastoid and upper cervical region to modulate vestibular afferent activity and downstream central vestibular processing. Stochastic "noisy" wideband waveforms can provide continuous vestibular afferent input while remaining below thresholds for overt vestibular reflexes when delivered at subthreshold intensities. Prior balance focused studies have delivered repeated subthreshold stochastic EVS without serious adverse events, supporting evaluation of EVS as a portable and scalable intervention for vestibular conditions. This study is designed as a pilot randomized sham controlled trial to evaluate the feasibility safety and tolerability of repeated EVS delivery in adults with a confirmed clinical diagnosis of VM and to generate preliminary estimates of symptom and functional change to inform the design of a future fully powered randomized controlled trial.

Approximately 50 adults with VM will be recruited through the Calgary Headache Assessment and Management Program and affiliated clinics. Following informed consent and completion of baseline assessments participants will be randomized in a one to one ratio to receive either active EVS or sham EVS using a pre specified allocation schedule. Where feasible randomization will be stratified by sex to promote balance between groups given known sex differences in VM prevalence and symptom expression. The study will use a quadruple masking such that participants, care providers administering stimulation, investigators, and outcome assessors will remain blinded to group assignment throughout the study. Allocation concealment will be maintained by separating roles between personnel responsible for intervention delivery and those conducting outcome assessments. Procedures for unblinding will be after the data has been cleaned and groups need to be separated for comparisons.

Participants will attend six stimulation sessions scheduled across a two week intervention period. Stimulation will be delivered while seated using a wideband noisy waveform at a subthreshold intensity intended to avoid overt vestibular sensations while providing continuous vestibular afferent input. Each visit will include two 20 minute stimulation bouts separated by a 5 minute rest period. Standardized electrode placement skin preparation and impedance checks will be performed at each visit to ensure consistency across sessions. Participants will be allowed to read, rest, or use personal electronic devices during stimulation. Investigators will document session timing adherence and any deviations from the protocol as well as participant reported sensations during and after stimulation.

Participants assigned to the sham condition will undergo identical electrode placement and session structure as the active group. At the beginning of each stimulation bout the device will briefly ramp to mimic cutaneous sensation associated with stimulation onset and will then deliver zero current for the remainder of the bout while maintaining device indicators. This approach preserves participant expectations, staff interaction, and visit structure while withholding therapeutic vestibular stimulation. Study personnel will follow identical scripted procedures and monitoring protocols for both groups to support masking integrity.

Safety and tolerability will be monitored throughout the study period. Investigators will document the onset, duration, severity, and perceived relatedness of all reported events. Criteria for pausing or discontinuing stimulation during a session will be applied if participants experience concerning symptoms. Adverse events will be summarized by frequency severity and relatedness to inform safety characterization and protocol refinement.

Study assessments will be conducted at baseline immediately following completion of the two week intervention period and approximately one month after the final stimulation session. At each assessment, visit participants will complete validated patient reported measures capturing vestibular migraine related symptom impact, migraine related disability dizziness, related functional burden balance confidence, and motion sensitivity susceptibility. Structured symptom provocation procedures relevant to visually and vestibular triggered symptoms will also be completed to characterize changes in symptom sensitivity over time. Objective evaluation of postural control and functional gait will be performed using wearable inertial measurement units (IMUs). IMUs placed on the head trunk and feet will capture kinematic data during quiet standing performed under systematically varied sensory conditions and during standardized functional mobility tasks. These measures will be complemented by computerized dynamic posturography to quantify sensory integration during stance. Standardized task instructions, sensor placement, and trial timing will be used across visits to support consistency and data quality.

To capture day to day variability typical of vestibular migraine and to evaluate the feasibility of longitudinal symptom monitoring participants will complete daily symptom diaries for 30 days before and 30 days after the two week stimulation period. Diaries will record vestibular episode characteristics migraine features perceived symptom severity sleep and medication use. Completion rates and patterns of missing data will be tracked to inform feasibility and to guide protocol optimization for future trials. Among participants who menstruate daily tracking of menstrual bleeding will be included to support exploratory evaluation of symptom patterning.

The primary focus of this pilot trial is feasibility and tolerability, including recruitment and retention adherence to the six session intervention and acceptability of the intervention and assessments. Clinical and functional outcomes will be analyzed using longitudinal approaches appropriate for repeated measures to estimate the direction and variability of change over time between stimulation and sham groups. Effect sizes and confidence intervals will be reported rather than definitive hypothesis testing to support sample size estimation and design refinement for a future definitive randomized controlled trial.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

Active subthreshold stochastic electrical vestibular stimulation

Experimental group

Description:

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.

Treatment:

Device: Electrical Vestibular Stimulation

Sham electrical vestibular stimulation

Sham Comparator group

Description:

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.

Treatment:

Device: Electrical Vestibular Stimulation Sham