Controlled DTI Evaluations in High School Football and Female Soccer to Evaluate Efficacy of Jugular Compression Collar
Condition: MTBI - Mild Traumatic Brain Injury; Concussion, Mild
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
Study type: Interventional

Summary: 
      The purpose of the study is to monitor longitudinal changes in brain structure between the
      preseason and postseason, in a population of football and soccer playing athletes wearing the
      Device and compared to a similar population not wearing the device. Secondly, the purpose is
      to determine the efficacy of device to reduce alterations in brain structure relative to
      amount and magnitude of sustained head impacts. Finally, to show that DTI efficacy and safety
      results can be prospectively confirmed in a multi-school investigation.

      Test the null hypotheses of no difference between collar users and non-collar users changes
      from baseline to end of season for:

        -  Primary: Alterations in pre-defined DTI metrics (AD, MD, RD) are significantly reduced
           in the neck collar group at EOS relative to BL.

        -  Secondary: Alterations in pre-defined DTI metrics is explained by the number of hits,
           the hit intensity, and the intensity per head impact over the season non-collar users.

      In addition, secondary analytics on data derived from injury surveillance (musculoskeletal,
      concussion and symptom/severity scores), behavioral (Trail Making, Postural Sway, Flanker,
      Task-switching, Near Point Convergence, ADHD and King Devick) or imaging (DTI, fMRI, T1, T2,
      and MRS) will be evaluated.
    

Detailed description: 
      Significant morbidity, mortality, and related costs are caused by traumatic brain injury
      (TBI). A simple, effective, and lightweight device worn by athletes or war fighters in the
      field, designed to mitigate TBI resulting from blast trauma or concussive events, would save
      lives, and the huge costs incurred for life-treatment of surviving victims. An
      externally-worn medical device that applies mild jugular compression according to the
      principle of the Queckenstedt Maneuver (the Device) is being developed by Q30 Sports Science,
      LLC (Q30). Preliminary research indicates that the Device has the potential to reduce the
      likelihood of alterations to brain microstructure. The currently developed collar has been
      approved for studies in humans and the results indicate safety for use during high demand and
      maximal exertion activities, Study IDs: 2013-2240, 2016-7948, 2014-5009, 2016-9625,
      2016-0988, and 2015-2205 Institutional Review Board - Federalwide Assurance #00002988). FDA
      has determined that this device is a nonsignificant risk (NSR) device study because it does
      not meet the definition of a significant risk (SR) device under § 812.3(m) of the
      investigational device exemptions (IDE) regulation (21 CFR 812).

      This study will investigate the effectiveness of this device in high school athletes playing
      a collision sport such as football or 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. Male football players and female soccer players will be included
      in this investigation. All participants may be outfitted with an accelerometer which will
      measure the magnitude of every impact to the head sustained by the athlete. This
      accelerometer will be affixed with an adhesive patch,(which will be placed behind the ear, to
      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 behavioral
      assessments following competitive football and soccer participation. The investigators will
      also enroll a group of athletes involved in a non-contact sport (such as cross-country) to
      act as controls.
    

Intervention name(s): Q collar
Intervention type(s): Other
Intervention description(s): An externally-worn medical device that applies mild jugular compression
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: two groups
Masking: None (Open Label)
Primary purpose: Prevention