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

Cincinnati Children's Hospital Medical Center

Status: Completed

Conditions: Concussion, Mild

Treatments: Device: Q collar

Study type: Interventional

Funder types: Other

Identifiers

NCT03017924

2016-7948

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

Q collar

Experimental group

Description:

Subjects that will wear the Q collar during the breacher training

Treatment:

Device: Q collar

No collar

No Intervention group

Description:

Subjects that will not wear the Q collar during the breacher training