search
Back to results

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

Primary Purpose

Concussion, Mild

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Q collar
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Concussion, Mild

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cincinnati Childrens Hospital Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Q collar

No collar

Arm Description

Subjects that will wear the Q collar during the breacher training

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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

Full Information

First Posted
January 10, 2017
Last Updated
January 28, 2021
Sponsor
Children's Hospital Medical Center, Cincinnati
search

1. Study Identification

Unique Protocol Identification Number
NCT03017924
Brief Title
Novel Protection Against Potential Brain, Hearing and Vision Injury During Blast Wave Exposure
Acronym
BLAST
Official Title
Novel Protection Against Potential Brain, Hearing and Vision Injury During Blast Wave Exposure
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Mild

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Q collar
Arm Type
Experimental
Arm Description
Subjects that will wear the Q collar during the breacher training
Arm Title
No collar
Arm Type
No Intervention
Arm Description
Subjects that will not wear the Q collar during the breacher training
Intervention Type
Device
Intervention Name(s)
Q collar
Intervention Description
q-collar concussion prevention device
Primary Outcome Measure Information:
Title
Blast Explosive Waves Experienced During the Training
Description
The blast explosive waves experienced during the training during the N-back fMRI testing and the rs fMRI testing
Time Frame
single breacher training day
Title
Average Peak Pressure Differences Between Groups
Description
between group differences in average peak pressure pre to post in collar versus no collar in both N-back fMRI and rfMRI
Time Frame
Pre-testing appointment occurred 24-48 hours before breacher training and post test appointment occurred 24-48 hours following breached training.
Secondary Outcome Measure Information:
Title
Between Group Differences in Total Impulse Pre to Post in Collar Versus no Collar
Description
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
Time Frame
Pre-testing appointment occurred 24-48 hours before breacher training and post test appointment occurred 24-48 hours following breached training.
Title
Change in DP-NF Value (Reported in Hz)
Description
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
Time Frame
Pre-testing appointment occurred 24-48 hours before breacher training and post test appointment occurred 24-48 hours following breached training.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory D Myer, PhD
Organizational Affiliation
Cincinanti Childrens Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Childrens Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs