Concussion Device Audiological Measures

For the testing sessions, subjects may either come to our testing site or the investigators may bring the testing to their location (e.g. schools, work). The subjects will be fitted with a device around your neck, like a neck tie. The Device incorporates two bulges localized over the site of the internal jugular veins bilaterally. Experiments performed with jugular Doppler ultrasound demonstrate that while wearing the Device, flows within the jugular veins are reduced, while flow within the carotid arteries and all portions of the cerebrum are preserved (JA Fisher, unpublished data). Thus, application of the Device to the subject will not cause any untoward health risks (IRB# 2013-2240 safety testing performed on this Device). The pressure exerted by the Device on the region of the neck superficial to the internal jugular vein is akin to the pressure felt when a person yawns or wears a snugly fitting necktie. The methods are utilized in prior approved IRB (2013-2240)..

Station I: Consent to Participate Each participant will review the Institutional Review Board approved consent to participate form prior to data collection. They will be given an adequate amount of time to ask questions to the study coordinator, or the person obtaining consent, and then make their decision to participate or not participate. If they wish to participate, they will be asked to sign the informed consent form. For middle school and high school subjects recruited via the investigators relationship with the schools, this station will be designated to review consent and assent forms to ensure that proper signatures have been obtained.

Station II: Device Fitting and Ultrasound The subjects will be outfitted with the device by a staff member appropriately trained in fitting the device in the proper location.

Station III: Wideband Absorbance and Oto-Acoustic Emissions This station will help determine the effectiveness of the device by measuring the auditory response of a clicking noise that will be non-invasively imparted into the subject's outer ear. For both tests, a soft silicone tip is placed into the outer ear, and sounds are delivered via a miniature speaker. For the wideband absorbance test, absorbed acoustic responses will be monitored to provide information on the operation of the collar device. These are measured as changes in the acoustic absorbance of the ear. For the oto-acoustic emission test, tones or clicks will be presented to the ear with the same soft ear probe and recording microphones pick up the oto-acoustic emission coming back from the outer hair cells of the inner ear. The computer averages and processes the responses in reference to a noise floor across a specified frequency range, displaying the results on the computer screen for the tester. The oto-acoustic emissions test also provides a brief hearing screening to determine if hearing is normal.

Evidence indicates that wideband absorbance and oto-acoustic emissions will be altered with increased intracranial pressure, thus this simple, non-invasive exam will provide feedback on the effectiveness of the device.