Novel Protection Against Potential Brain, Hearing and Vision Injury During Blast Wave Exposure

Not Applicable

Completed

Brief Summary: The purpose of the study is to monitor changes in brain structure and function between the pre-training and post-training, in a population of tactical team members wearing the Device and compared to a similar population not wearing the device. Secondly, the purpose is to determine the protection of the device relative to amount and magnitude of sustained head impacts.

Detailed Description: This study will investigate the effectiveness of this device in tactical team members exposed to blast waves during tactical training. Subjects participating in this study will be randomly assigned to one of two groups: 1) Device wearing during the tactical training or 2) Non-device wearing during the tactical training. The helmets of all participants will be outfitted with an accelerometer which will measure the magnitude of every concussive blast wave sustained by the subject. Effectiveness of the device will be determined via differences in brain MRI and EEG, vision and hearing testing prior to and following standardized breaching and diversionary device scenario training.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Unable to provide written consent
History of neurological deficits, previous cerebral infarction, or severe head trauma as indicated through pre-tactical training screening:
Medical contraindications to restriction of venous outflow via the internal jugular veins (known increased intracerebral pressure, metabolic acidosis or alkalosis)
Glaucoma (Narrow Angle or Normal Tension)
Hydrocephalus
Recent penetrating brain trauma (within 6 months)
Known carotid hypersensitivity
Known increased intracranial pressure
Central vein thrombosis
Any known airway obstruction
Any known seizure disorder

Arm && Interventions

Group	Intervention	Description
Q collar	Q collar	Subjects that will wear the Q collar during the breacher training

Primary Outcome Measures

Name	Time	Method
Blast Explosive Waves Experienced During the Training	single breacher training day	The blast explosive waves experienced during the training during the N-back fMRI testing and the rs fMRI testing
Average Peak Pressure Differences Between Groups	Pre-testing appointment occurred 24-48 hours before breacher training and post test appointment occurred 24-48 hours following breached training.	between group differences in average peak pressure pre to post in collar versus no collar in both N-back fMRI and rfMRI

Secondary Outcome Measures

Name	Time	Method
Change in DP-NF Value (Reported in Hz)	Pre-testing appointment occurred 24-48 hours before breacher training and post test appointment occurred 24-48 hours following breached training.	pre to post training change in the DP-NF value (the dB difference between the distortion product emission and the noise floor amplitudes) between the collar and no collar groups reported in Hz
Between Group Differences in Total Impulse Pre to Post in Collar Versus no Collar	Pre-testing appointment occurred 24-48 hours before breacher training and post test appointment occurred 24-48 hours following breached training.	between group differences in total impulse pre to post in collar versus no collar in both the n-back fMRI and the rs fMRI testing conditions