NCT01549145已完成不适用
Sub-chronic Neurostimulation Delivered in the Middle Ear for Tinnitus Suppression
EstimME Ltd.1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2010年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Efficacy
研究概览
简要总结
The objectives of this study are to evaluate the safety and efficacy of applying electrical stimulation on the promontorium (EPS) for the suppression of tinnitus in a sub-chronic stimulation regimen.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Total score on the Handicap Inventory (THI) of at least
- •Visual scale over
- •Tinnitus origin is peripheral (related to long term noise exposure, or to a sudden exposure to a very loud noise etc.)
- •Tinnitus is on-going; present for more than 50% of the time over the past 12 months.
- •Unilateral tinnitus
- •Tinnitus prevalent at least 12 months.
- •Willingness to abstain from part taking in other, non-study procedures indicated to lessen tinnitus and/or its perception.
- •Willing and able to refrain from engaging in activities or work involving loud noise exposure.
- •Male or females 18-60 years of age
排除标准
- •Prior history of sudden hearing loss and/or fluctuating hearing levels.
- •Tinnitus prevalent more than 3 years.
- •History of frequent middle ear infections
- •Patient under immunosuppressant therapy
- •Auditory nerve damage.
- •Vestibular Schwannoma
- •Cochlear implant.
- •Pregnant or lactating.
- •Developmental disability or cognitive impairment that would make it difficult for the subject to partake in the clinical study, including adequate comprehension of the informed consent form and ability to record the necessary measurements.
- •Involvement in litigation and/or a worker's compensation claim and/or receiving disability benefits related to tinnitus and/or hearing loss.
- •Not being physically or geographically capable of returning for scheduled follow-up visits.
- •Any physical, psychological, or emotional disorder that would interfere with the planned surgical operations
- •Mentally retarded, developmentally delayed or suffering from organic brain dysfunction.
结局指标
主要结局
Efficacy
时间窗: 2 months
Study efficacy evaluations will be based on the analysis of pre and post procedure tinnitus severity characteristics (THI, MML, Pitch matching and VAS values).
次要结局
- Safety(2 months)
研究者
研究点 (1)
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