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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
23
q-collar concussion prevention device
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States
Blast Explosive Waves Experienced During the Training
The blast explosive waves experienced during the training during the N-back fMRI testing and the rs fMRI testing
Time frame: single breacher training day
Average Peak Pressure Differences Between Groups
between group differences in average peak pressure pre to post in collar versus no collar in both N-back fMRI and rfMRI
Time frame: 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
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
Time frame: Pre-testing appointment occurred 24-48 hours before breacher training and post test appointment occurred 24-48 hours following breached training.
Change in DP-NF Value (Reported in Hz)
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
Time frame: Pre-testing appointment occurred 24-48 hours before breacher training and post test appointment occurred 24-48 hours following breached training.
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