VIBRANT-VM: Vestibular Investigation of Bone-conducted Resonant Analysis of Time-constants in Patients With Vestibular Migraines
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 4
- 主要终点
- Reduction of time constant
研究概览
简要总结
The goal of this clinical trial is to learn if the Otolith Labs device can improve vestibular function of subjects with vestibular migraine.
The main questions it aims to answer are:
- When the Otolith Labs device is on, are objective measures of the vestibular system better than when the device is off?
- When the Otolith Labs device is on are subjective measures of the vestibular system better than when the device is off?
- Are the objective measures related to the subjective measures?
Researchers will change the order of the device settings to ensure the changes aren't due to the order they are tested.
Participants will:
- Wear the Otolith Labs device while in a rotary chair at different settings for different tests. All of the rotary chair testing will take less than an hour.
- Answer questions about how the rotary chair testing made them feel for each test.
- Answer questions about their every-day susceptibility to motion sickness and about their vestibular migraine symptoms.
详细描述
This study is designed to investigate the effects of The Otolith Labs bone conduction device (BCD) on the vestibular system. In the context of this trial, the BCD was designed and developed to reduce the effects of external stimulation of the vestibular system. The eventual intended use of the device is for people who have vestibular disorders (e.g. Vestibular Migraine, Meniere's Disease) who may benefit from a device that can provide a normalizing response to an abnormal vestibular neural signal.
To better understand the functioning principles of the BCD, the investigators want to conduct standard clinical testing using a rotary chair, specifically
- Step velocity testing (SVT) with the chair rotating and vision denied
- Optokinetic testing (OKT) with the chair stationary and visual field moving
Published studies have demonstrated that a reduction in the vestibulo-ocular reflex (VOR) time constants during optokinetic and velocity step testing is correlated with improved motion sickness symptoms. The investigators aim to determine if the BCD similarly reduces the VOR time constant. A reduction in time constant has been shown to be strongly correlated with a reduced time constant of integration in the central velocity storage (a long time constant very strongly correlates with motion sensitivity and with the severity of vestibular migraine episodes.
In this study, the BCD is set at one of three settings- turned off, low power level, high power level, -while the participant is undergoing testing at 60 °/s (patient's own motion for step velocity testing, or projected image for OKT). The same test methodology and equipment shall be used for all participants. In total, 6 rotational tests - one clockwise rotation and one counterclockwise rotation at each of the three power settings, and 6 static tests - with the visual field moving left then right at each of the three power settings, will be conducted and the order of the high/low power settings will be randomized to the second/third set of SVT and OKT. The device is adjusted to a new power level a few seconds before initiating each SVT and OKT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The device setting order is randomized to the participant.
入排标准
- 年龄范围
- 21 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Definite or probable vestibular migraine
- •Residing in the United States
排除标准
- •Head injury (e.g. skull fracture, concussion) within the last six months
- •Neurodegenerative disorder
- •Recent use of specified medications
- •History of:
- •Vestibular neuritis / labyrinthitis
- •Vestibular schwannoma or acoustic neuroma
- •Radiographically unexplored unilateral or sudden sensorineural hearing loss
- •History of surgery to the skull base or head,
- •Surgery to the middle ear in the past 6 months,
- •Surgery to the inner ear (e.g. labyrinthectomy) at any time.
- •Eye surgery within the previous 3 months
- •Significant reported history of ear disease, intravenous ototoxic medications
研究组 & 干预措施
Off low high
Device order will start with the device turned on but stimulation off, then the low setting and then the high setting
干预措施: Otolith Device Active (Device)
Off high low
Device order will start with the device turned on but stimulation off, then the high setting and then the low setting
干预措施: Otolith Device Active (Device)
Off off off
Device will always be turned on but stimulation off to measure test-retest variability.
干预措施: Otolith Device Inactive (Device)
结局指标
主要结局
Reduction of time constant
时间窗: 60 minutes
Time constant of slow-phase saccade attenuation in rotary chair
次要结局
- Motion sickness symptom(60 minutes)
- Vestibular migraine handicap(60 minutes)
- Motion sickness experience(60 minutes)
