Electrical Vestibular Stimulation as a Novel Neuromodulation Therapy for Vestibular Migraine: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM PATHI) score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Active subthreshold stochastic electrical vestibular stimulation
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.
干预措施: Electrical Vestibular Stimulation (Device)
Sham electrical vestibular stimulation
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.
干预措施: Electrical Vestibular Stimulation Sham (Device)
结局指标
主要结局
Change in Vestibular Migraine Patient Assessment Tool and Handicap Inventory (VM PATHI) score
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
- 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)
- Change in modified Motion Sensitivity Test (mMST) score(Baseline and immediately post intervention)
- Change in IMU derived postural sway metrics during standing balance tests(Baseline, immediately post intervention, and one month post intervention)
- Change in gait performance during 25-foot walking test(Baseline, immediately post intervention, and one month post intervention)
- Change in gait performance on Timed Up and Go (TUG)(Baseline, immediately post intervention, and one month post intervention)
- Change in Sensory Organization Test (SOT) equilibrium and sensory ratios(Baseline, immediately post intervention, and one month post intervention)