NCT03017924

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Concussion, Mild

Interventions

Type	Name	Description
DEVICE	Q collar	q-collar concussion prevention device

Timeline

• Start date: 2016-12-01
• Primary completion: 2017-03-01
• Completion: 2017-12-01
• First posted: 2017-01-11
• Last updated: 2021-02-16
• Results posted: 2021-02-16

Locations

1 site across 1 country: United States