<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03236389</url>
  </required_header>
  <id_info>
    <org_study_id>2016-6895</org_study_id>
    <nct_id>NCT03236389</nct_id>
  </id_info>
  <brief_title>Brain Dynamics in Response to Jugular Vein Compression</brief_title>
  <official_title>Brain Dynamics in Response to Jugular Vein Compression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Clinical trials have suggested that this device is effective in mitigating changes in brain&#xD;
      structure and function in athlete populations. The purpose of the current study is to better&#xD;
      understand the underlying mechanistic response of the brain hemodynamics to mild jugular vein&#xD;
      compression&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Significant morbidity, mortality, and related costs are caused by traumatic brain injury&#xD;
      (TBI). A simple, effective, and lightweight device worn by athletes or war fighters in the&#xD;
      field, designed to mitigate TBI resulting from blast trauma or concussive events, would save&#xD;
      lives, and the huge costs currently being experienced for life-treatment of surviving&#xD;
      victims. An externally-worn medical device (the Device) that applies mild jugular vein&#xD;
      compression according to the principle of the Queckenstedt Maneuver, is being developed by&#xD;
      Q30 Sports Science, LLC (Q30). Preliminary research suggests that the Device has the&#xD;
      potential to reduce the likelihood of TBI. The currently developed collar (Smith 2009, Smith&#xD;
      and Fisher 2011, Smith and Fisher 2011, Smith 2012) has been approved for studies in humans&#xD;
      (IRB 2013-2240) and the results indicate safety for use during high demand and maximal&#xD;
      exertion activities. Regarding safety, the externally worn collar is meticulously designed to&#xD;
      mimic the body's own omohyoid muscle actions upon the jugular veins that will provide similar&#xD;
      pressure and volume increases not to surpass that of a yawn or the mere act of just lying&#xD;
      down. Initial safety testing and early clinical trials indicate that the collar application&#xD;
      is both safe and efficacious to prevent brain microstructure and neurophysiological changes&#xD;
      in response to head impacts.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2016</start_date>
  <completion_date type="Actual">December 2020</completion_date>
  <primary_completion_date type="Actual">December 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in brain structure while wearing Q collar seen via MRI</measure>
    <time_frame>immediate</time_frame>
    <description>measure changes in brain structure on MRI</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Concussion, Mild</condition>
  <arm_group>
    <arm_group_label>Collar Wearing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>subjects will wear collar during MRI testing</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Q Collar</intervention_name>
    <description>measuring changes in brain during MRI while wearing the Q collar</description>
    <arm_group_label>Collar Wearing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Normal healthy volunteer aged 7-40&#xD;
&#xD;
          -  Able to provide written consent&#xD;
&#xD;
          -  Able to tolerate hypercapnia for 1-2 minutes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to provide written consent&#xD;
&#xD;
          -  History of neurological deficits, previous cerebral infarction, or severe head trauma&#xD;
             as indicated through pre-season screening:&#xD;
&#xD;
          -  Medical contraindications to restriction of venous outflow via the internal jugular&#xD;
             veins (known increased intracerebral pressure, metabolic acidosis or alkalosis)&#xD;
&#xD;
          -  Glaucoma (Narrow Angle or Normal Tension)&#xD;
&#xD;
          -  Hydrocephalus&#xD;
&#xD;
          -  Recent penetrating brain trauma (within 6 months)&#xD;
&#xD;
          -  Known carotid hypersensitivity&#xD;
&#xD;
          -  Known increased intracranial pressure&#xD;
&#xD;
          -  Central vein thrombosis&#xD;
&#xD;
          -  Any known airway obstruction&#xD;
&#xD;
          -  Any known seizure disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gregory D Myer, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cincinnati Childrens Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cincinnati Childrens Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>January 24, 2023</last_update_submitted>
  <last_update_submitted_qc>January 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Concussion</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03236389
org study id: 2016-6895
nct id: NCT03236389
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Clinical trials have suggested that this device is effective in mitigating changes in brain
      structure and function in athlete populations. The purpose of the current study is to better
      understand the underlying mechanistic response of the brain hemodynamics to mild jugular vein
      compression
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 currently being experienced for life-treatment of surviving
      victims. An externally-worn medical device (the Device) that applies mild jugular vein
      compression according to the principle of the Queckenstedt Maneuver, is being developed by
      Q30 Sports Science, LLC (Q30). Preliminary research suggests that the Device has the
      potential to reduce the likelihood of TBI. The currently developed collar (Smith 2009, Smith
      and Fisher 2011, Smith and Fisher 2011, Smith 2012) has been approved for studies in humans
      (IRB 2013-2240) and the results indicate safety for use during high demand and maximal
      exertion activities. Regarding safety, the externally worn collar is meticulously designed to
      mimic the body's own omohyoid muscle actions upon the jugular veins that will provide similar
      pressure and volume increases not to surpass that of a yawn or the mere act of just lying
      down. Initial safety testing and early clinical trials indicate that the collar application
      is both safe and efficacious to prevent brain microstructure and neurophysiological changes
      in response to head impacts.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Changes in brain structure while wearing Q collar seen via MRI
time frame: immediate
description: measure changes in brain structure on MRI
arm group label: Collar Wearing
arm group type: Experimental
description: subjects will wear collar during MRI testing
intervention type: Device
intervention name: Q Collar
description: measuring changes in brain during MRI while wearing the Q collar
arm group label: Collar Wearing
criteria: 
gender: All
minimum age: 7 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gregory D Myer, PhD
role: Principal Investigator
affiliation: Cincinnati Childrens Hospital
facility: 
country: United States
responsible party type: Sponsor
mesh term: Brain Concussion
sharing ipd: No