N/A N=23 Randomized Prevention

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

Concussion, Mild

Bottom Line

View on ClinicalTrials.gov: NCT03017924 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2021

Primary outcome: Primary: Blast Explosive Waves Experienced During the Training — 4.11; 4.29; 4.20; 4.0 number of blasts

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Q collar (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Children's Hospital Medical Center, Cincinnati
Primary completion: Mar 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Blast Explosive Waves Experienced During the Training	4.11; 4.29; 4.20; 4.0	—
PRIMARY Average Peak Pressure Differences Between Groups	1.67; 1.99; 1.67; 1.81	—
SECONDARY Between Group Differences in Total Impulse Pre to Post in Collar Versus no Collar	6.58; 7.67; 6.9; 6.95	—
SECONDARY Change in DP-NF Value (Reported in Hz)	0.98; 0.64; 1.64; -0.5; 5.15; -1.44	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03017924). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.