Efficacy of a Transcranial Vibrating System for Mitigation of Outcomes of Migraine Associated Vertigo
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Brain confusion
研究概览
简要总结
Vertigo is among the most common symptoms associated with migraine and affects 26.5% of migraine sufferers, leading to a dramatic impact in life limiting even the most simple activities. A new device, the OtoBand, a transcranial vibrating system, has been shown to mitigate and sometimes prevent vertigo and nausea in healthy subjects. The current study aims to determine if the Otoband can treat or reduce symptoms of Migraine Associated Vertigo (MAV).
详细描述
Vertigo is among the most common symptoms associated with migraine and affects 26.5% of migraine sufferers. Migraine Associated Vertigo (MAV) has a dramatic impact on daily life, impacting work, relationships, and even activities of daily living. At the current time, the mainstay of therapy for migraine is pharmaceutical intervention, either acute (particularly triptans, 2) or preventative. However, this therapy has a delayed effect and can lead to a host of side effects.
In this project we examine a device that has shown promise and might be beneficial for treating or improving the course of recovery from MAV. The Otoband is a transcranial vibrating system to be placed against the skull, preferably over the mastoid bone, behind the ear. To date, the device has only been systematically tested on healthy volunteers and has shown improvement of vertigo symptoms during the use of virtual reality systems and road motion sickness.
Individuals identified at Jefferson University medical center with a history of MAV attacks will be referred to the Otolaryngology Department where their diagnosis will be confirmed and offered to enroll in the study. Participants will be able to take home an Otoband to wear when they have MAV attacks. The Otoband will be set at the effective power (proved to reduce vertigo symptoms in previous studies) and low power (proved to not impact vertigo symptoms, considered as sham device). Participants will have to assay their vertigo symptoms before, during and immediately after wearing the Otoband to evaluate the efficacy of the device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Neither the subject nor the investigators in the study will know the calendar's schedule for normal or placebo power levels. At both settings, the device will be felt to vibrate, making it unlikely that participants will be able to guess which setting is effective and which is ineffective.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject between the ages of 18-65 with a history of frequent Migraine Associated Vertigo (MAV) attacks as characterized by the following:
- •An episode with acute onset vertigo that lasted at least 15 minutes within the previous 30 days.
- •At least 5 such episodes in the past 12 months.
排除标准
- •History of head injury within the last six months or currently suffering the effects of a head injury
- •Presence of severe aphasia
- •History of diagnosed neuropsychiatric disorders (e.g. hypochondriasis, major depression, schizophrenia)
- •Documented neurodegenerative disorders
- •Pregnancy [Female candidates will be asked if they are pregnant]
- •Prior disorders of hearing and balance including:
- •Ménière's disease
- •Multiple sclerosis
- •Vestibular neuritis
- •Vestibular schwannoma
- •Sudden sensorineural hearing loss
- •History of Cerebrovascular disorders
- •History of ear operation other than myringotomy and tube placement in the past
- •Planned major surgery of the skull base (for instance, cochlear implant)
- •Systemic disorders to include chronic renal failure, cirrhosis of the liver, autoimmune disease, heart disease, lung disease, or severe arthritis
- •Individuals who cannot provide informed consent
结局指标
主要结局
Brain confusion
时间窗: 2 minutes and 20 minutes after starting the Otoband; and 20 minutes after stopping the Otoband
Questionnaire for brain confusion: scale from 0 (none) to 10 (maximum) for the 4 following symptoms: forgetful, difficulty thinking/finding words, difficulty focusing, cloudy.
Change in vertigo symptoms
时间窗: 2 minutes and 20 minutes after starting the Otoband; and 20 minutes after stopping the Otoband
Questionnaire for vertigo symptoms from 0 (none) to 10 (agonizing)
次要结局
- Change in headache symptoms(2 minutes and 20 minutes after starting the Otoband; and 20 minutes after stopping the Otoband)
- Change in nausea symptoms(2 minutes and 20 minutes after starting the Otoband; and 20 minutes after stopping the Otoband)