Functional Manifestations of Pressure Changes in the Middle Ear System: An fMRI Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- changes in brain activation during pressure changes
研究概览
简要总结
This study is looking at whether functional magnetic resonance imaging (fMRI) can see if and when the brain responds to pressure stimulations of the eardrum. The study requires 2 visits, 1 for screening to determine eligibility and 1 for the fMRI. This study will help to understand how the middle ear system is controlled, which may have an impact on how people with middle ear disease are treated.
详细描述
Otitis media is a ubiquitous disease in young children which can persist through adolescence, and arise or recur in adults. A consequence of an infection and/or Eustachian tube dysfunction, it manifests as an effusion that disrupts the normal impedance matching function of tympanic membrane-ossicular chain system. Eustachian tube dysfunction prevents the equilibration of middle ear pressures and drainage of the accumulated effusion. It is thought that middle ear status modulates the function of the Eustachian tube via afferent signals processed centrally resulting in changes in its tonus or muscular function. This pilot study of right-handed 21-35 year olds of either sex will validate a published fMRI method for visualizing cortical brain activation in response to external ear canal pressure changes (N=5). The outcome measure is intensity changes of the cortex associated with applied stimuli.
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
- 21 Years 至 35 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •21-35 years of age
- •right-handed
排除标准
- •left-handedness or ambidexterity
- •fMRI safety reasons (ferromagnetic material in their bodies, epilepsy, claustrophobia
- •history of middle ear/tympanic membrane surgery (tympanostomy tubes)
- •abnormal otoscopic findings and/or tympanometry on physical exam
- •pregnancy
结局指标
主要结局
changes in brain activation during pressure changes
时间窗: 1 hour (Visit 2, during fMRI)
Subjects will have fMRIs while pressure is varied in the right ear (+/-40 decapascals). Changes in brain activation during pressure changes will be measured by fMRI during approximately 1 hour scanning time.
次要结局
未报告次要终点
研究者
J. Douglas Swarts
Research Associate Professor of Otolaryngology
University of Pittsburgh
