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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Q collar | Experimental | Subjects that will wear the Q collar during the breacher training |
|
| No collar | No Intervention | Subjects that will not wear the Q collar during the breacher training |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Q collar | Device | q-collar concussion prevention device |
|
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory D Myer, PhD | Cincinanti Childrens Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Childrens Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Collar Group | Subjects that will wear the Q collar during the breacher training Q collar: q-collar concussion prevention device |
| FG001 | Non-Collar Group | Subjects that will not wear the Q collar during the breacher training |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Collar Group | Subjects that will wear the Q collar during the breacher training Q collar: q-collar concussion prevention device |
| BG001 | Non-Collar Group | Subjects that will not wear the Q collar during the breacher training |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | some subjects had head motion during the scan | Posted | Mean | Standard Deviation | number of blasts | single breacher training day |
|
1 week
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Collar Group | Subjects that will wear the Q collar during the breacher training Q collar: q-collar concussion prevention device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kim Foss | Cincinnati Childrens Hospital | 5136365971 | kim.foss@cchmc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 22, 2016 | Aug 20, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 22, 2016 | Sep 14, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | Kg |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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 | some subjects had head motion | Posted | Mean | Standard Deviation | pounds per square inch | Pre-testing appointment occurred 24-48 hours before breacher training and post test appointment occurred 24-48 hours following breached training. |
|
|
|
| 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 | All subject data available for this measure - no data lost due to head motion | Posted | Mean | Standard Deviation | units on a scale (psi*ms) | Pre-testing appointment occurred 24-48 hours before breacher training and post test appointment occurred 24-48 hours following breached training. |
|
|
|
| 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 | all subject data available for this analysis | Posted | Mean | Standard Deviation | Change in pre to post Dp (reported in Hz | Pre-testing appointment occurred 24-48 hours before breacher training and post test appointment occurred 24-48 hours following breached training. |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Non-Collar Group | Subjects that will not wear the Q collar during the breacher training | 0 | 11 | 0 | 11 | 0 | 11 |
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| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| rs fMRI Average peak pressure (psi) |
|
|
| 3000 Hz Right |
|
| 3000 Hz Left |
|
| 4000 Hz right |
|
| 4000 Hz left |
|
| 6000 Hz right |
|
| 6000 Hz left |
|
| 8000 Hz right |
|
| 8000 Hz left |
|