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

Concussion, Mild Clinical Trial

— BLAST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03017924
• Other study ID #: 2016-7948
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 2017

Study information

• Verified date: January 2021
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Concussion, Mild

Intervention

Device:
• Q collar
q-collar concussion prevention device

Locations

Country	Name	City	State
United States	Cincinnati Childrens Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.
Secondary	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.