<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/NCT04423198</url>
  </required_header>
  <id_info>
    <org_study_id>CLIN01001</org_study_id>
    <nct_id>NCT04423198</nct_id>
  </id_info>
  <brief_title>HEAD Injury Serum Markers and Multi-modalities for Assessing Response to Trauma</brief_title>
  <acronym>HeadSMART II</acronym>
  <official_title>HEAD Injury Serum Markers and Multi-modalities for Assessing Response to Trauma II</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BRAINBox Solutions Inc</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BRAINBox Solutions Inc</source>
  <oversight_info>
    <has_dmc>No</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>
      The goal of HeadSMART II (HEAD injury Serum markers and Multi-modalities for Assessing&#xD;
      Response to Trauma II) is to develop an In-Vitro Diagnostic, the BRAINBox TBI test, to aid in&#xD;
      the diagnosis and prognosis of patients with mild traumatic brain injury, by incorporating&#xD;
      blood biomarkers, clinical assessments, and tools to measure associated neurocognitive&#xD;
      impairments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study proposes to collect data using a multi-modality approach including blood&#xD;
      biomarkers, clinical assessments, neurocognitive performance, and neuropsychological&#xD;
      characteristics, to identify subjects with a mild Traumatic Brain Injury (TBI) and their&#xD;
      likelihood of chronic symptoms.&#xD;
&#xD;
      This is an observational study with an expectation of enrolling up to 2000 subjects. These&#xD;
      subjects will include the intended use population, subjects presenting to the Emergency&#xD;
      Department or Urgent Care with a blunt head trauma. Data will be collected across four time&#xD;
      points, T=0, 14 days, 30 days and 90 days, to allow for building and validating the&#xD;
      algorithms for both diagnosis and prognosis claims.&#xD;
&#xD;
      Control populations, healthy and trauma only (no head trauma) will be included for assay&#xD;
      development. Data will be collected for these groups at T=0 and 14 days (trauma control&#xD;
      only).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 31, 2020</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation of mild traumatic brain injury diagnosis using the BRAINBox TBI Test compared to the Expert Clinical Diagnosis</measure>
    <time_frame>30 days</time_frame>
    <description>Sensitivity and specificity of the diagnosis as compared to a clinical diagnosis by an expert committee</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determine the risk stratification of having symptoms at 14, 30 and 90 days, for subjects with mild traumatic brain injury using the BRAINBox TBI Test results.</measure>
    <time_frame>up to 90 days</time_frame>
    <description>Sensitivity and specificity of the risk for chronic symptoms as compared to the post-concussion symptoms at predefined time points</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Mild Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>Target Condition</arm_group_label>
    <description>Subjects presenting to the Emergency Department (ED) or Urgent Care (UC) with a blunt head trauma</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Trauma Control</arm_group_label>
    <description>Subjects presenting to the ED or UC requiring an Xray but do not have a head trauma</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Control</arm_group_label>
    <description>Subjects that are healthy and not taking any prescription medications</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Assessment</intervention_name>
    <description>Self administered cognitive battery</description>
    <arm_group_label>Healthy Control</arm_group_label>
    <arm_group_label>Target Condition</arm_group_label>
    <arm_group_label>Trauma Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Patient Reported Neurological Outcome Assessments</intervention_name>
    <description>Standard neurocognitive and neuropsychological tests</description>
    <arm_group_label>Target Condition</arm_group_label>
    <arm_group_label>Trauma Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Blood Draw</intervention_name>
    <description>Specimen collection of whole blood, serum, RNA</description>
    <arm_group_label>Healthy Control</arm_group_label>
    <arm_group_label>Target Condition</arm_group_label>
    <arm_group_label>Trauma Control</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Specimen Samples for the analysis of biomarkers include:&#xD;
&#xD;
        1. Serum&#xD;
&#xD;
        2. RNA&#xD;
&#xD;
        3. Whole blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects presenting to the Emergency Department or Urgent Care with a blunt head trauma.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Target Condition Subjects&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          1. Age &gt;=18 years&#xD;
&#xD;
          2. Ability to provide a blood sample; within 96 hours of injury&#xD;
&#xD;
          3. Ability to provide informed consent. Consent may be obtained with assistance of a&#xD;
             legally authorized representative (LAR)&#xD;
&#xD;
          4. Must present to the Emergency Department (ED) or Urgent Care (UC) with a blunt head&#xD;
             trauma&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Glasgow Coma Scale (GCS) score &lt; 13, as presented in ED at time of screening&#xD;
&#xD;
          2. Need for general anesthesia at the time of presentation in the ED&#xD;
&#xD;
          3. Diagnosed dementia requiring assistance for daily living&#xD;
&#xD;
          4. Any head trauma requiring medical attention from a physician within the last 6 months&#xD;
&#xD;
          5. Received chemotherapy or radiation within the last year&#xD;
&#xD;
          6. History of stroke with disabling outcomes, brain tumor, epilepsy or intracranial&#xD;
             surgery/hemorrhage&#xD;
&#xD;
          7. Psychiatric hospitalization in the last 90 days&#xD;
&#xD;
          8. Blood transfusion within the prior 4 weeks&#xD;
&#xD;
          9. Non-working telephone number&#xD;
&#xD;
         10. Current participant in an interventional clinical trial&#xD;
&#xD;
         11. Cannot perform study tasks on an iPad (e.g. not wearing corrective lenses necessary to&#xD;
             read, inability to use both hands)&#xD;
&#xD;
         12. Subject considered unsuitable for participation in this clinical trial by PI, treating&#xD;
             clinician or research study staff&#xD;
&#xD;
        Control Subjects&#xD;
&#xD;
        Inclusion:&#xD;
&#xD;
          1. Age &gt;=18 years&#xD;
&#xD;
          2. Ability to provide a blood sample; (For Trauma Controls (TC's) within 96 hours of&#xD;
             injury)&#xD;
&#xD;
          3. Ability to provide informed consent. (For TC's consent may be obtained with assistance&#xD;
             of a legally authorized representative (LAR)&#xD;
&#xD;
          4. Presents to the Emergency Department or Urgent Care with at least one injury requiring&#xD;
             an X-Ray (TC's only)&#xD;
&#xD;
          5. Healthy and not taking prescription medications (Healthy Controls (HC's) only)&#xD;
&#xD;
        Exclusion:&#xD;
&#xD;
          1. Head trauma or symptoms with head trauma at presentation&#xD;
&#xD;
          2. Head trauma requiring medical attention from a physician within the last 6 months&#xD;
&#xD;
          3. Internal organ injury (e.g. liver laceration, pulmonary contusion, spinal cord injury)&#xD;
             that requires inpatient hospitalization&#xD;
&#xD;
          4. Need for general anesthesia at the time of presentation in the ED&#xD;
&#xD;
          5. Diagnosed dementia requiring assistance for daily living&#xD;
&#xD;
          6. Received chemotherapy or radiation within the last year&#xD;
&#xD;
          7. History of stroke with disabling outcomes, brain tumor, epilepsy or intracranial&#xD;
             surgery/hemorrhage&#xD;
&#xD;
          8. Psychiatric hospitalization in the last 90 days&#xD;
&#xD;
          9. Blood transfusion within the prior 4 weeks&#xD;
&#xD;
         10. Non-working telephone number&#xD;
&#xD;
         11. Current participant in an interventional clinical trial&#xD;
&#xD;
         12. Cannot perform study tasks on an iPad (e.g. not wearing corrective lenses necessary to&#xD;
             read, inability to use both hands)&#xD;
&#xD;
         13. Subject considered unsuitable for participation in this clinical trial by PI, treating&#xD;
             clinician or research study staff&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Frank Peacock, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baylor College of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Donna Edmonds</last_name>
    <phone>804-212-2975</phone>
    <email>dedmonds@brainboxinc.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Andrea Brown, MS</last_name>
    <phone>408-881-2611</phone>
    <email>abrown@brainboxinc.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lucas Lemar</last_name>
      <phone>913-588-3580</phone>
    </contact>
    <investigator>
      <last_name>Chad Cannon, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Detroit Receiving</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Justin Sabol</last_name>
    </contact>
    <investigator>
      <last_name>Robert Welch, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Harper University Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Justin Sabol</last_name>
    </contact>
    <investigator>
      <last_name>Robert Welch, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sinai Grace Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48235</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Justin Sabol</last_name>
    </contact>
    <investigator>
      <last_name>Robert Welch, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Rochester Medical Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14620</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kian Merchant-Borna, MPH, MBA</last_name>
    </contact>
    <investigator>
      <last_name>Jeffrey Bazarian, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Stony Brook Medicine</name>
      <address>
        <city>Stony Brook</city>
        <state>New York</state>
        <zip>11794</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maria Taylor</last_name>
    </contact>
    <investigator>
      <last_name>Adam Singer, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hannah Zamore</last_name>
    </contact>
    <investigator>
      <last_name>Danielle Sandsmark, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>John Peter Smith (JPS) Health Network</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maximillian Masuda</last_name>
    </contact>
    <investigator>
      <last_name>James P d'Etienne, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine/Ben Taub</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kelly Keene</last_name>
      <phone>713-873-9818</phone>
    </contact>
    <investigator>
      <last_name>Zubaid Rafique, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Baylor College of Medicine/St. Luke's Medical Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kelly Keene</last_name>
    </contact>
    <investigator>
      <last_name>Zubaid Rafique, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Carilion Clinic</name>
      <address>
        <city>Roanoke</city>
        <state>Virginia</state>
        <zip>24014</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Daniella Rodriguez</last_name>
      <phone>540-588-3183</phone>
    </contact>
    <investigator>
      <last_name>Damon R Kuehl, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>August 2, 2021</last_update_submitted>
  <last_update_submitted_qc>August 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>TBI, mTBI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Brain Concussion</mesh_term>
    <mesh_term>Craniocerebral Trauma</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04423198
org study id: CLIN01001
nct id: NCT04423198
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The goal of HeadSMART II (HEAD injury Serum markers and Multi-modalities for Assessing
      Response to Trauma II) is to develop an In-Vitro Diagnostic, the BRAINBox TBI test, to aid in
      the diagnosis and prognosis of patients with mild traumatic brain injury, by incorporating
      blood biomarkers, clinical assessments, and tools to measure associated neurocognitive
      impairments.
This study proposes to collect data using a multi-modality approach including blood
      biomarkers, clinical assessments, neurocognitive performance, and neuropsychological
      characteristics, to identify subjects with a mild Traumatic Brain Injury (TBI) and their
      likelihood of chronic symptoms.

      This is an observational study with an expectation of enrolling up to 2000 subjects. These
      subjects will include the intended use population, subjects presenting to the Emergency
      Department or Urgent Care with a blunt head trauma. Data will be collected across four time
      points, T=0, 14 days, 30 days and 90 days, to allow for building and validating the
      algorithms for both diagnosis and prognosis claims.

      Control populations, healthy and trauma only (no head trauma) will be included for assay
      development. Data will be collected for these groups at T=0 and 14 days (trauma control
      only).
observational model: Cohort
time perspective: Prospective
measure: Correlation of mild traumatic brain injury diagnosis using the BRAINBox TBI Test compared to the Expert Clinical Diagnosis
time frame: 30 days
description: Sensitivity and specificity of the diagnosis as compared to a clinical diagnosis by an expert committee
measure: Determine the risk stratification of having symptoms at 14, 30 and 90 days, for subjects with mild traumatic brain injury using the BRAINBox TBI Test results.
time frame: up to 90 days
description: Sensitivity and specificity of the risk for chronic symptoms as compared to the post-concussion symptoms at predefined time points
arm group label: Target Condition
description: Subjects presenting to the Emergency Department (ED) or Urgent Care (UC) with a blunt head trauma
arm group label: Trauma Control
description: Subjects presenting to the ED or UC requiring an Xray but do not have a head trauma
arm group label: Healthy Control
description: Subjects that are healthy and not taking any prescription medications
intervention type: Behavioral
intervention name: Cognitive Assessment
description: Self administered cognitive battery
arm group label: Healthy Control
arm group label: Target Condition
arm group label: Trauma Control
intervention type: Behavioral
intervention name: Patient Reported Neurological Outcome Assessments
description: Standard neurocognitive and neuropsychological tests
arm group label: Target Condition
arm group label: Trauma Control
intervention type: Procedure
intervention name: Blood Draw
description: Specimen collection of whole blood, serum, RNA
arm group label: Healthy Control
arm group label: Target Condition
arm group label: Trauma Control
Specimen Samples for the analysis of biomarkers include:

        1. Serum

        2. RNA

        3. Whole blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Frank Peacock, MD
role: Principal Investigator
affiliation: Baylor College of Medicine
last name: Donna Edmonds
phone: 804-212-2975
email: dedmonds@brainboxinc.com
last name: Andrea Brown, MS
phone: 408-881-2611
email: abrown@brainboxinc.com
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
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facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
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facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
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country: United States
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Brain Concussion
mesh term: Craniocerebral Trauma
mesh term: Wounds and Injuries
sharing ipd: Undecided