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临床试验/NCT01932736
NCT01932736已完成不适用

Functional Manifestations of Pressure Changes in the Middle Ear System: An fMRI Study

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2013年8月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

J. Douglas Swarts

Research Associate Professor of Otolaryngology

University of Pittsburgh

研究点 (2)

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