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

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.

Study Overview

• Status: Completed
• Conditions: Concussion, Mild
• Intervention / Treatment: Device: Q collar

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 Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Childrens Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Q collar; Subjects that will wear the Q collar during the breacher training	Device: Q collar; q-collar concussion prevention device
No Intervention: No collar; Subjects that will not wear the Q collar during the breacher training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: January 10, 2017
• First Submitted That Met QC Criteria: January 10, 2017
• First Posted (Estimate): January 11, 2017

Study Record Updates

• Last Update Posted (Actual): February 16, 2021
• Last Update Submitted That Met QC Criteria: January 28, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: 2016-7948

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO