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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Concussion, Mild

Intervention / Treatment
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* Device: Q collar


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Normal healthy volunteer Able to provide written consent 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Q collar<br>Subjects that will wear the Q collar during the breacher training | Device: Q collar<br>* q-collar concussion prevention device<br>|
| No Intervention: No collar<br>Subjects that will not wear the Q collar during the breacher training | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Pre-testing appointment occurred 24-48 hours before breacher training and post test appointment occurred 24-48 hours following breached training. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Pre-testing appointment occurred 24-48 hours before breacher training and post test appointment occurred 24-48 hours following breached training. |