Neuromodulation Treatment of Vestibular Migraines
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Dizziness Handicap Inventory
研究概览
简要总结
This is a non-randomized pilot study to test the efficacy of neuromodulation via caloric stimulation on vestibular migraines. All subject who meet the study criteria will be in an active treatment group. All subjects will report the frequency of the migraines and undergo periodic testing of symptoms.
详细描述
This is a non-blinded, non-randomized pilot study of individuals with vestibular migraines. The goal is to test the efficacy of neuromodulation on both migraine and dizziness symptoms in patients with documented vestibular migraines. Treatment will consist of 9 months of active treatment followed by 3 months of observation. The active treatment requires two daily 20 minute sessions wearing a device over the ears that delivers a very small amount of warm air to the ears. All subjects will undergo a series of tests at baseline and at discrete intervals during the 1 year of observation.
Primary and Secondary endpoints are listed below:• Primary Efficacy Endpoints
- Reduction in the frequency and severity of migraine headaches (self reported in pain diary)
- Reduction in the frequency and intensity of perceived vestibular symptoms (Dizziness Handicap Inventory (DHI), Activity Balance confidence scale (ABC), Oscillopsia Test, Symptoms questionnaire), OVRT Goggle profile.
Secondary Efficacy Endpoints for the Pilot Study
- Improvement in sleep quality and/or quantity as assessed by the Epworth Sleep Scale.
- Improvement in quality of life as assessed by the HIT-6 survey.
- Improvement in mood/anxiety as assessed with the T2 Mood Tracker app (National Center for Telehealth & Technology).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults, between the ages of 18 and 75 who have been diagnosed with VM least 3 months prior to entering into the study.
- •The Investigator must have confidence in the patient's ability to reliably use the CVS Device and complete the requirements of the study.
排除标准
- •are pregnant
- •have a history of cardiovascular disease
- •work night shifts
- •have a history of unstable mood disorder or unstable anxiety disorder
- •use a hearing aid
- •have a cochlear implant
- •abuse alcohol or other drugs
- •are experiencing Medication Overuse Headaches (individuals with respect to whom the Investigator is concerned that analgesic abuse is involved based on the ICHD-II guidelines).
- •have had eye surgery within the previous three months or ear surgery within the previous six months
- •have active ear infections or a perforated tympanic membrane
- •have participated in another clinical trial within the last 30 days or are currently enrolled in another clinical trial
研究组 & 干预措施
Device
Neuromodulation
干预措施: Device (Device)
结局指标
主要结局
Dizziness Handicap Inventory
时间窗: Until study completion up to 12 months
Questionnaire of dizziness symptoms
Headache Impact Test
时间窗: Until study completion up to 12 months
Headache questionnaire
Activities Balance Confidence Interval
时间窗: Until study completion up to 12 months
Dizziness questionnaire
OVRT Testing
时间窗: Until study completion up to 12 months
Oculomotor, vestibular, and reaction time tests
次要结局
- Epworth Sleepiness Scale(Until study completion up to 12 months)
- T2 Mood Tracker app(Until study completion up to 12 months)
研究者
Michael E. Hoffer
Professor
University of Miami