Exploring Mild Electrical Vestibular Stimulation as a New Treatment for Dizziness and Migraine Symptoms
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.
detailed 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.
official title
Electrical Vestibular Stimulation as a Novel Neuromodulation Therapy for Vestibular Migraine: a Pilot Randomized Controlled Trial