Tinnitus Related Cerebral Activities: Personalised Approach of the Tinnitus Treatment
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 24
- 主要终点
- Measure of the BOLD activity by MRI
研究概览
简要总结
The proposed research is to identify the brain areas activated or deactivated by tinnitus in humans. The identification of these areas is expected to be able to treat tinnitus refractory to traditional therapies by methods of brain stimulation. Furthermore, this technique would be very useful to verify the effectiveness of any treatment to relieve tinnitus.
The brain activation measured during fMRI will be performed in a position of rest, after inhibition of tinnitus, and after application of a sound that does not inhibit tinnitus. This comparison will identify specific brain areas activated or deactivated by tinnitus.
详细描述
- What is the purpose of the research?
The proposed research is to identify the brain areas activated or deactivated by tinnitus in humans.
The identification of these areas is expected to be able to treat tinnitus refractory to traditional therapies by methods of brain stimulation.
Furthermore, this technique would be very useful to verify the effectiveness of any treatment to relieve tinnitus. 2. What is the methodology?
This is a diagnosis based on functional brain imaging with MRI (fMRI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age limits to > 18 years and < 70 years
- •Voluntary study participation
- •Unhurt of any acute or chronic pathology of the ear (except tinnitus and a possible deafness of perception in the limits fixed below) on the basis of the interrogation and of the clinical examination
- •presenting a single sided tinnitus
- •Presenting on the side of the tinnitus a phenomenon of residual inhibition with a duration of total disappearance of the tinnitus of more than 30 seconds
- •easily reached
- •informed consent signed
- •Affiliation or recipient with the mode of social security
排除标准
- •Subjects incapable to understand the nature and the purposes of the study and/or having difficulty of communication with the investigator
- •majors protected by the law or privated of liberty by judiciary or administrative decision
- •pregnant woman
- •instable tinnitus (difference upper than 3 on mean of the EVA realised during the 5 days before the inclusion)
- •insufficient tinnitus intensity (mean of the EVA realised during the 5 days before the inclusion<4)
- •Anomaly of the external or average ear
- •Tinnitus attributed to a clearly identified retro-cochlear origin
- •Deafness of transmission of more than 15 dB on the tonal audiometry
- •Deafness of perception of more than 60 dB in average hearing loss (arithmetic mean) on the frequencies of 0,5-1-2 and 4 kHz.
- •Renowned ototoxic treatment during the duration of the protocol (malaria medicines, ototoxic chemotherapy, ototoxic antibiotic treatment),
- •Pursuit of a noise exposure of strong intensity with title professional and/or of leisure, dental treatment with use of engine or turbine, during the duration of the protocol.
- •Contraindication in the examination MRI (pacemaker, port of surgical clips in the cervico-cephalic region or implanted medical surgical material susceptible to mobilize under the influence of magnetic gradients, foreign body intraocular, pieces of shrapnel at the cervico-cephalic level (possibility of artefact), claustrophobia, pregnancy of less than 3 months)
- •History of cranial trauma with encephalic infringement(achievement), ischemic cerebrovascular accident or intracerebral bruise.
结局指标
主要结局
Measure of the BOLD activity by MRI
时间窗: 6 months
Measure is done by MRI
次要结局
- Measure of the BOLD activity on resting state by MRI(6 months)