Novel Protection Against Potential Brain, Hearing and Vision Injury During Blast Wave Exposure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Blast Explosive Waves Experienced During the Training
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Q collar
Subjects that will wear the Q collar during the breacher training
Intervention: Q collar (Device)
No collar
Subjects that will not wear the Q collar during the breacher training
Outcomes
Primary Outcomes
Blast Explosive Waves Experienced During the Training
Time Frame: 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
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 average peak pressure pre to post in collar versus no collar in both N-back fMRI and rfMRI
Secondary Outcomes
- 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.)
- 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.)