Concussion, Mild
Conditions
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.
Interventions
DEVICEQ collar
q-collar concussion prevention device
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blast Explosive Waves Experienced During the Training | single breacher training day | 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 | Pre-testing appointment occurred 24-48 hours before breacher training and post test appointment occurred 24-48 hours following breached training. | between group differences in average peak pressure pre to post in collar versus no collar in both N-back fMRI and rfMRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Between Group Differences in Total Impulse Pre to Post in Collar Versus no Collar | Pre-testing appointment occurred 24-48 hours before breacher training and post test appointment occurred 24-48 hours following breached training. | 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-testing appointment occurred 24-48 hours before breacher training and post test appointment occurred 24-48 hours following breached training. | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Collar Group Subjects that will wear the Q collar during the breacher training
Q collar: q-collar concussion prevention device | 12 |
| Non-Collar Group Subjects that will not wear the Q collar during the breacher training | 11 |
| Total | 23 |
Baseline characteristics
| Characteristic | Collar Group | Total | Non-Collar Group |
|---|---|---|---|
| Age, Continuous | 39.72 years STANDARD_DEVIATION 6.79 | 44.27 years STANDARD_DEVIATION 8.58 | 48.81 years STANDARD_DEVIATION 10.37 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 12 participants | 23 participants | 11 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 12 Participants | 23 Participants | 11 Participants |
| Weight | 99.10 Kg STANDARD_DEVIATION 17.58 | 96.49 Kg STANDARD_DEVIATION 16.34 | 93.88 Kg STANDARD_DEVIATION 15.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 11 |
| other Total, other adverse events | 0 / 12 | 0 / 11 |
| serious Total, serious adverse events | 0 / 12 | 0 / 11 |
Outcome results
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
Time frame: Pre-testing appointment occurred 24-48 hours before breacher training and post test appointment occurred 24-48 hours following breached training.
Population: some subjects had head motion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Collar Group | Average Peak Pressure Differences Between Groups | N-Back fMRI Average peak pressure (psi) | 1.67 pounds per square inch | Standard Deviation 0.44 |
| Collar Group | Average Peak Pressure Differences Between Groups | rs fMRI Average peak pressure (psi) | 1.67 pounds per square inch | Standard Deviation 0.42 |
| Non-Collar Group | Average Peak Pressure Differences Between Groups | N-Back fMRI Average peak pressure (psi) | 1.99 pounds per square inch | Standard Deviation 0.41 |
| Non-Collar Group | Average Peak Pressure Differences Between Groups | rs fMRI Average peak pressure (psi) | 1.81 pounds per square inch | Standard Deviation 0.53 |
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
Time frame: single breacher training day
Population: some subjects had head motion during the scan
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Collar Group | Blast Explosive Waves Experienced During the Training | Number of blasts N-Back fMRI | 4.11 number of blasts | Standard Deviation 3.37 |
| Collar Group | Blast Explosive Waves Experienced During the Training | Number of blasts rs fMRI | 4.20 number of blasts | Standard Deviation 3.19 |
| Non-Collar Group | Blast Explosive Waves Experienced During the Training | Number of blasts N-Back fMRI | 4.29 number of blasts | Standard Deviation 2.06 |
| Non-Collar Group | Blast Explosive Waves Experienced During the Training | Number of blasts rs fMRI | 4.0 number of blasts | Standard Deviation 2.12 |
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
Time frame: Pre-testing appointment occurred 24-48 hours before breacher training and post test appointment occurred 24-48 hours following breached training.
Population: All subject data available for this measure - no data lost due to head motion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Collar Group | Between Group Differences in Total Impulse Pre to Post in Collar Versus no Collar | n-Back fMRI total impulse | 6.58 units on a scale (psi*ms) | Standard Deviation 4.19 |
| Collar Group | Between Group Differences in Total Impulse Pre to Post in Collar Versus no Collar | rs FMRI total impulse | 6.9 units on a scale (psi*ms) | Standard Deviation 4.08 |
| Non-Collar Group | Between Group Differences in Total Impulse Pre to Post in Collar Versus no Collar | n-Back fMRI total impulse | 7.67 units on a scale (psi*ms) | Standard Deviation 3.31 |
| Non-Collar Group | Between Group Differences in Total Impulse Pre to Post in Collar Versus no Collar | rs FMRI total impulse | 6.95 units on a scale (psi*ms) | Standard Deviation 3.66 |
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
Time frame: Pre-testing appointment occurred 24-48 hours before breacher training and post test appointment occurred 24-48 hours following breached training.
Population: all subject data available for this analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Collar Group | Change in DP-NF Value (Reported in Hz) | 2000 Hz right | 0.98 Change in pre to post Dp (reported in Hz | Standard Deviation 5.1 |
| Collar Group | Change in DP-NF Value (Reported in Hz) | 2000 Hz Left | 1.64 Change in pre to post Dp (reported in Hz | Standard Deviation 6.91 |
| Collar Group | Change in DP-NF Value (Reported in Hz) | 3000 Hz Right | 5.15 Change in pre to post Dp (reported in Hz | Standard Deviation 11.36 |
| Collar Group | Change in DP-NF Value (Reported in Hz) | 3000 Hz Left | 2.81 Change in pre to post Dp (reported in Hz | Standard Deviation 10.28 |
| Collar Group | Change in DP-NF Value (Reported in Hz) | 4000 Hz right | 5.63 Change in pre to post Dp (reported in Hz | Standard Deviation 6.48 |
| Collar Group | Change in DP-NF Value (Reported in Hz) | 4000 Hz left | 1.54 Change in pre to post Dp (reported in Hz | Standard Deviation 7.57 |
| Collar Group | Change in DP-NF Value (Reported in Hz) | 6000 Hz right | 1.93 Change in pre to post Dp (reported in Hz | Standard Deviation 10.4 |
| Collar Group | Change in DP-NF Value (Reported in Hz) | 6000 Hz left | -1.68 Change in pre to post Dp (reported in Hz | Standard Deviation 9.6 |
| Collar Group | Change in DP-NF Value (Reported in Hz) | 8000 Hz right | 1.43 Change in pre to post Dp (reported in Hz | Standard Deviation 6.97 |
| Collar Group | Change in DP-NF Value (Reported in Hz) | 8000 Hz left | 1.13 Change in pre to post Dp (reported in Hz | Standard Deviation 12.21 |
| Non-Collar Group | Change in DP-NF Value (Reported in Hz) | 6000 Hz left | 3.55 Change in pre to post Dp (reported in Hz | Standard Deviation 9.24 |
| Non-Collar Group | Change in DP-NF Value (Reported in Hz) | 2000 Hz right | 0.64 Change in pre to post Dp (reported in Hz | Standard Deviation 3.61 |
| Non-Collar Group | Change in DP-NF Value (Reported in Hz) | 4000 Hz left | 2.57 Change in pre to post Dp (reported in Hz | Standard Deviation 6.5 |
| Non-Collar Group | Change in DP-NF Value (Reported in Hz) | 2000 Hz Left | -0.5 Change in pre to post Dp (reported in Hz | Standard Deviation 6.91 |
| Non-Collar Group | Change in DP-NF Value (Reported in Hz) | 8000 Hz left | 4.23 Change in pre to post Dp (reported in Hz | Standard Deviation 9.61 |
| Non-Collar Group | Change in DP-NF Value (Reported in Hz) | 3000 Hz Right | -1.44 Change in pre to post Dp (reported in Hz | Standard Deviation 6.47 |
| Non-Collar Group | Change in DP-NF Value (Reported in Hz) | 6000 Hz right | -1.29 Change in pre to post Dp (reported in Hz | Standard Deviation 8.88 |
| Non-Collar Group | Change in DP-NF Value (Reported in Hz) | 3000 Hz Left | -1.29 Change in pre to post Dp (reported in Hz | Standard Deviation 10.42 |
| Non-Collar Group | Change in DP-NF Value (Reported in Hz) | 8000 Hz right | 1.54 Change in pre to post Dp (reported in Hz | Standard Deviation 12.52 |
| Non-Collar Group | Change in DP-NF Value (Reported in Hz) | 4000 Hz right | -2.01 Change in pre to post Dp (reported in Hz | Standard Deviation 6.85 |