NCT01176734已完成不适用
The Treatment of Tinnitus With Transcutaneous Non-invasive Vagus Nerve stimulation-a Controlled Randomized Pilot Study Assessing Safety, Compatibility and Clinical Performance
cerbomed GmbH2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2010年1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
- 50
- 试验地点
- 2
- 主要终点
- Safety, feasibility and effectiveness of t-VNS® stimulation
研究概览
简要总结
The t-VNS STv3 device is a non-invasive, transcutaneous neurostimulator for influencing the afferent branches of the nervus vagus around the human ear. The clinical trial is designed as a a pilot study addressing the treatment of tinnitus with transcutaneous vagus nerve stimulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 否
入选标准
- •Chronic tinnitus defined as a tinnitus over more than six months
- •≥31 points in the tinnitus questionnaire according to Goebel and Hiller
- •Written informed consent
- •Both gender, aged from 18 -75 years
- •If the subject takes psychoactive medication (e.g antidepressants, anticonvulsives) therapy must be stable for at least 10 days. If a treatment with neuroleptics is necessary, only olanzapine and quetiapine should be used. The therapy should be constantly though a necessary change in medication is no reason for exclusion of the subject.
排除标准
- •Objective tinnitus
- •Participating in other tinnitus treatments within 3 months before study start
- •Missing informed consent
- •Pregnancy
- •Bronchial asthma in medical history
- •Clinically relevant internistic, neurological or psychiatric diseases
- •Abuse of drugs or alcohol until 12 weeks before enrollment in the study
- •Indications of structural impairment of the basal ganglia or the brain stem
- •Active implants (e.g. cochlea implants, VNS, pacemaker)
- •Constant all-day use of hearing instruments or noisers on the left the part-time use in special situations (e.g. watching TV is no exclusion criteria
- •All dermatologic and infectious diseases which affect the area around the pinna and the ear canal
- •Severe malformation of the pinna
- •Other circumstances that in the opinion of the investigator might be an obstacle for enrolling the subject
结局指标
主要结局
Safety, feasibility and effectiveness of t-VNS® stimulation
时间窗: 24 weeks
Determination of safety, feasibility and effectiveness of t-VNS measured by tinnitus score according to Goebel and Hiller between baseline and week 24
次要结局
未报告次要终点
研究者
研究点 (2)
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