Pilot Study of Modulating Auditory Symptoms and Vertigo of Meniere's Disease by Non-invasive Mastoid Electric Stimulation: Double-blind, Randomized, Sham-controlled, Investigator-initiated Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Valuation of dizziness with Dizziness Visual Analogue scale(Efficacy)
研究概览
简要总结
This study is a Double-blind, Randomized, Sham-controlled, Investigator-initiated trial. To explore the effectiveness of non-invasive inner ear electrical stimulation of the mastoid behind the ear in controlling auditory symptoms and dizziness in patients with Meniere's disease.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with dizziness (Meniere's) only, who understand the nature of the study and are willing to participate voluntarily.
- •The frequency of the hearing loss is between 250 kHz and 1 kHz.
- •Patients with bilateral 500, 1000, and 2000 Hz hearing threshold averages within 65 dB HL
- •Patients who have received conventional pharmacotherapy for other dizziness conditions with a washout period of 2 months.
- •To be eligible for subjects in the active phase of the disease, there must be at least 1 vertigo attack in the 6 months before study entry.
- •If tests for renal function, electrolytes, etc. are performed and no problems are found
排除标准
- •Patients with an otologic condition other than Meniere'ss (dizziness) (otitis media, profound hearing loss, hyperacusis, etc.).
- •Patients' conditions that may affect EEG measurements, such as a stroke, brain hemorrhage, or brain tumor.
- •Patients with kidney disease
- •Patients Have or have had a serious medical condition, such as cancer (including leukemia, blood cancers, epilepsy, and neuropsychiatric conditions).
- •Patients with an artificial implant in the body (cochlear implant, hip joint, pacemaker, etc.)
- •Women of childbearing potential, pregnant women, or nursing mothers
- •Patients who can have Injuries or dermatologic abnormalities at the site of application of the equipment.
- •Patients with coronary artery disease, uncontrolled high blood pressure, or other serious medical conditions (including kidney disease).
研究组 & 干预措施
electircal stimulation + betahistine
干预措施: YPS-201b (Device)
electircal stimulation + betahistine
干预措施: betahistine (Drug)
sham electircal stimulation + betahistine
干预措施: betahistine (Drug)
sham electircal stimulation + betahistine
干预措施: YPS-201b (Device)
betahistine
control group
干预措施: betahistine (Drug)
结局指标
主要结局
Valuation of dizziness with Dizziness Visual Analogue scale(Efficacy)
时间窗: 0,2,4,8,12 weeks during electrical stimulation
Verifying therapeutic effect of electrical stimulation
Evaluate vestibular-ocular reflex with Video head impulse test(Efficacy)
时间窗: 0,4,8,12 weeks during electrical stimulation
Verifying therapeutic effect of electrical stimulation,evaluate the function of the vestibulocochlear reflex in the semicircular canal and measure the extent of improvement in Meniere's disease.
electroencephalography(Efficacy)
时间窗: 0,1,4,8,12 weeks during electrical stimulation
Verifying therapeutic effect of electrical stimulation,evaluate the inhibitory response of the brain through EEG readings following repeated stimulation.
Valuation of hearing threshold with pure tone audiometry(Efficacy)
时间窗: 0,4,8,12 weeks during electrical stimulation
Verifying therapeutic effect of electrical stimulation.measuring the level of enhancement in low-frequency hearing.
次要结局
未报告次要终点