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

Completed · Not applicable

Conditions studied: Concussion, Mild

In brief

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.

Key facts

Study ID

NCT03017924

Run by

Children's Hospital Medical Center, Cincinnati

People needed

23

Starts

2016-12-01

Expected to finish

2017-12-01

Last updated by the study team

2021-02-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Normal healthy volunteer
• Able to provide written consent

You may not qualify if…

• 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

Where it is running

• Cincinnati Childrens Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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