Concussion, Brain, Concussion, Mild
Conditions
Brief summary
The purpose of the study is to monitor longitudinal changes in brain structure and function between the preseason and postseason, in a population of soccer playing athletes 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 high school athletes playing a non-helmeted sport such as soccer. Athletes participating in this study will be randomly assigned to one of two groups: 1) Device wearing during the season or 2) Non-device wearing during the season. This study will focus on the use and effectiveness of the device solely in females, as male football and hockey players have previously been investigated. All participants will be outfitted with an adhesive patch-like accelerometer (which will be placed behind the ear (Xpatch-X2 Biosystems http://www.x2biosystems.com/x2\_x\_patch/) which will measure the magnitude of every impact to the head sustained by the athlete. Effectiveness of the device will be determined via differences in longitudinal brain imaging and functional testing following competitive soccer participation. A subset of athletes who report a diagnosed concussion will also receive additional brain neuroanatomical and neurophysiological testing within a week following the diagnosed concussive event. At each of these time points participants will also undergo various neurocognitive assessments
Interventions
DEVICEQ Collar
Collar designed to mitigate slosh in the brain
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 19 Years
Healthy volunteers
Yes
Inclusion criteria
* Female * Normal healthy volunteer * Able to provide written consent * Must be 14 years or older and a participant on a high school soccer team
Exclusion criteria
* Unable to provide written consent * History of neurological deficits, previous cerebral infarction, or severe head trauma as indicated through pre-season 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 |
|---|---|---|
| Pre-season to Post-season DTI Percentage Change | 6 months | Determine % changes in brain structure between pre-season and post-season in AD, axial diffusivity; FA, fractional anisotropy; MD, mean diffusivity; RD, radial diffusivity. |
| Number of Participants Completing EEG | 6 months | Number of participants completing EEG |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Collar Group Soccer girls that wore the collar device
Q Collar: Collar designed to mitigate slosh in the brain | 44 |
| No Collar Group soccer girls that did not wear the collar | 28 |
| Total | 72 |
Baseline characteristics
| Characteristic | Collar Group | No Collar Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 44 Participants | 28 Participants | 72 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age of participant | 16.06 years STANDARD_DEVIATION 1.1 | 15.95 years STANDARD_DEVIATION 1.04 | 16.0 years STANDARD_DEVIATION 1.07 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 44 participants | 28 participants | 72 participants |
| Sex: Female, Male Female | 44 Participants | 28 Participants | 72 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 28 |
| other Total, other adverse events | 0 / 44 | 0 / 28 |
| serious Total, serious adverse events | 0 / 44 | 0 / 28 |
Outcome results
Primary
Number of Participants Completing EEG
Number of participants completing EEG
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Collar Group | Number of Participants Completing EEG | 44 Participants |
| No Collar Group | Number of Participants Completing EEG | 28 Participants |
Primary
Pre-season to Post-season DTI Percentage Change
Determine % changes in brain structure between pre-season and post-season in AD, axial diffusivity; FA, fractional anisotropy; MD, mean diffusivity; RD, radial diffusivity.
Time frame: 6 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Collar Group | Pre-season to Post-season DTI Percentage Change | FA | -0.17 percentage of change | Standard Deviation 1.99 |
| Collar Group | Pre-season to Post-season DTI Percentage Change | MD | 0.45 percentage of change | Standard Deviation 2.23 |
| Collar Group | Pre-season to Post-season DTI Percentage Change | AD | 0.37 percentage of change | Standard Deviation 2.23 |
| Collar Group | Pre-season to Post-season DTI Percentage Change | RD | 0.53 percentage of change | Standard Deviation 2.72 |
| No Collar Group | Pre-season to Post-season DTI Percentage Change | RD | 3.52 percentage of change | Standard Deviation 2.6 |
| No Collar Group | Pre-season to Post-season DTI Percentage Change | FA | -1.27 percentage of change | Standard Deviation 1.35 |
| No Collar Group | Pre-season to Post-season DTI Percentage Change | AD | 2.58 percentage of change | Standard Deviation 2.34 |
| No Collar Group | Pre-season to Post-season DTI Percentage Change | MD | 2.83 percentage of change | Standard Deviation 2.46 |