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

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

Sponsors

Lead sponsor: Children's Hospital Medical Center, Cincinnati

Source Children's Hospital Medical Center, Cincinnati
Brief 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.

Overall Status Unknown status
Start Date December 2016
Completion Date December 2017
Primary Completion Date March 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
change in brain structure on MRI 3 weeks
Enrollment 25
Condition
Intervention

Intervention type: Device

Intervention name: Q collar

Description: q-collar concussion prevention device

Arm group label: Q collar

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Gregory D Myer, PhD Principal Investigator Cincinanti Childrens Hospital
Location
facility Cincinnati Childrens Hospital Medical Center
Location Countries

United States

Verification Date

October 2017

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Q collar

Arm group type: Experimental

Description: Subjects that will wear the Q collar during the breacher training

Arm group label: No collar

Arm group type: No Intervention

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

Acronym BLAST
Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov