Concussion Device Audiological Measures
Condition: Concussion; Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional

Summary: 
      Significant morbidity, mortality, and related costs are caused by traumatic brain injury
      (TBI). A simple, effective, and lightweight device worn by athletes or war fighters in the
      field, designed to mitigate TBI resulting from blast trauma or concussive events, would save
      lives, and the huge costs currently being experienced for life-treatment of surviving
      victims. An externally-worn medical device that applies mild jugular compression according to
      the principle of the Queckenstedt Maneuver (the Device) is being developed by Q30 Labs, LLC
      (Q30). Initial research suggests that the Device has the potential to reduce the likelihood
      of TBI. The rationale for testing wideband absorbance and Oto-acoustics emissions (OAE) is
      that the investigators need a physiologic, non-invasive method to evaluate the brain
      responses to mild jugular compression across multiple age groups. To determine this with MR
      imaging is currently cost prohibitive. The investigators pilot data from the parent IRB
      indicates a consistent response measured via wideband absorbance in young adults. Therefore,
      a preliminary step to evaluate the safety and efficacy of the neck collar device is to employ
      this technology across a wide range of ages.
    

Detailed description: 
      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      preserved (JA Fisher, unpublished data).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.

      During the wideband absorbance and oto-acoustic emissions testing the study participants will
      also be fitted with a compressive circumferential neck collar which can provide variable and
      specific levels of pressure. The pressure is achieved by inflatable pods that sit adjacent to
      the trachea affixed to a non-stretch adjustable collar. Manual inflation is regulated and
      monitored by an experience operator/ technician through a bulb style pump and an electronic
      gauge. Testing will occur without pressure and then with pressures applied up to 40mmHg.

      Station IV: Hearing Assessment Otoscopy will be performed by an audiologist to note any ear
      blockages, such as wax or drainage for exclusion purposes. The oto-acoustic emissions test
      will be interpreted to determine if normal responses were obtained in each ear. If abnormal,
      a hearing screening using pure tone audiometry screening will be provided free of charge. In
      the event that the hearing screening is determined to be abnormal, the subject will receive
      the results which may be shared with their primary care provider to determine any need for
      referral for follow-up. If a subject is seen for follow-up at CCHMC following an abnormal
      hearing assessment, this visit and any follow up visits will not be paid for by this project
      and will be subject to insurance billing.
    

Intervention name(s): Device Wearing
Intervention type(s): Device
Intervention description(s): Q30 collar - collar designed to be worn around the neck to apply slight pressure to jugular veins. Each subject will undergo repeat oto-acoustic measures both wearing the device and not wearing the device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Brain; Hearing; MTBI