Functional Manifestations of Pressure Changes in the Middle Ear System
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Functional Manifestations of Pressure Changes in the Middle Ear System: An fMRI Study|
- changes in brain activation during pressure changes [ Time Frame: 1 hour (Visit 2, during fMRI) ] [ Designated as safety issue: No ]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.
|Study Start Date:||August 2013|
|Estimated Study Completion Date:||April 2016|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Experimental: healthy volunteers
healthy volunteers undergo pressure changes in ear canal
Other: changing ear canal pressure
ear canal pressure changes: pressure varied from +/-40 decapascals
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01932736
|United States, Pennsylvania|
|Middle Ear Physiology Laboratory, University of Pittsburgh School of Medicine|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Douglas Swarts, PhD||University of Pittsburgh|