<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/NCT02992327</url>
  </required_header>
  <id_info>
    <org_study_id>A15-085</org_study_id>
    <nct_id>NCT02992327</nct_id>
  </id_info>
  <brief_title>Biomarker Levels as A Predictor of Concussion Severity OUTcomes (BlacOut)</brief_title>
  <acronym>BlacOut</acronym>
  <official_title>Biomarker Levels as A Predictor of Concussion Severity OUTcomes (BlacOut)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HealthPartners Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>HealthPartners Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall research aim of this pilot study is to determine if the structural brain protein&#xD;
      calpain-cleaved αII-spectrin N-terminal fragment (SNTF) can be used as a blood biomarker to&#xD;
      accurately identify patients who will have more severe symptoms and reduced neurocognitive&#xD;
      functioning after sustaining a concussion. Concussion is also referred to as mild traumatic&#xD;
      brain injury (mTBI) in the literature. Both terms will be used interchangeably throughout&#xD;
      this application.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The novel aspect of the proposed study relates to the fact that the STNF protein is the first&#xD;
      evidence that a biomarker in human blood can help clinicians determine a specific patient's&#xD;
      clinical outcome from a concussion. This in turn will help clinicians and concussion&#xD;
      specialists with designing treatment protocols very early after the initial injury that could&#xD;
      have significant impacts on the health of the patient.&#xD;
&#xD;
      This study has several important benefits to the scientific community. Concussion treatment&#xD;
      today is uncertain. Some patients are back to baseline one or two days post injury whereas&#xD;
      other patients are experiencing debilitating symptoms for months after the injury. Until the&#xD;
      patient begins to report symptoms, the course of treatment cannot be determined. Other&#xD;
      biomarkers for concussion diagnosis are being evaluated, but this is the first biomarker to&#xD;
      show promise for patient stratification and earlier intervention and treatment for the subset&#xD;
      of cases at high risk of suffering brain damage and persisting dysfunction after concussion.&#xD;
      Currently, no prognostic method exists for identifying at an early and potentially treatable&#xD;
      stage the small subset of concussion sufferers at risk of diffuse axonal injury and&#xD;
      persisting brain functional impairment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 30, 2015</start_date>
  <completion_date type="Actual">August 6, 2018</completion_date>
  <primary_completion_date type="Actual">August 6, 2018</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>Results of neurocognitive testing</measure>
    <time_frame>30 days from index injury</time_frame>
    <description>Neurocognitive testing a 30 days post injury to assess symptom severity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Symptom severity</measure>
    <time_frame>30 days post injury</time_frame>
    <description>assay level of SNTF biomarker</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SNTF plasma and serum levels</measure>
    <time_frame>24 hours, 30 days and 90 days post injury</time_frame>
    <description>SNTF plasma and serum levels measured with 24 hours of injury, at 30 days, at 90 days.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Concussion, Mild</condition>
  <condition>Neurocognitive Dysfunction</condition>
  <arm_group>
    <arm_group_label>Cohort</arm_group_label>
    <description>Patients age ≥ 8 years of age with a GCS &gt;13 presenting to the emergency department with a diagnosis of concussion.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      The laboratory has developed and characterized extensively an antibody that reacts with the&#xD;
      SNTF (structural brain protein calpain-cleaved αII-spectrin N-terminal fragment) fragment of&#xD;
      aII-spectrin but does not recognize either the intact aII-spectrin or any other fragment of&#xD;
      it. The laboratory has used this antibody as a foundation for an ultrasensitive, specific,&#xD;
      standardized sandwich immunoassay for measuring trace quantities of SNTF in human serum and&#xD;
      plasma in the acute period after brain injury19,27 The method employs state-of-the-art&#xD;
      electrochemiluminescence chemistry that is widely used in the clinical diagnostics arena for&#xD;
      measuring protein biomarkers in biological fluids.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Normal volunteers presenting to the emergency department with a diagnosis of concussion.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patient is ≥ 8 years old 2. Ability to enroll within 24 hours of injury 3. Ability to&#xD;
        follow-up with patient 30 days following enrollment 4. Concussion by history or physical&#xD;
        examination (head injury and symptoms such as headache, nausea, vomiting, dizziness,&#xD;
        fatigue, irritability, or poor concentration following the injury) 5. GCS ≥ 13 6.&#xD;
        Abbreviated Injury Score (AIS) ≤ 3 7. Plan to be discharged from the emergency department&#xD;
        to the outpatient observation unit or to home&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Non-English speaking 2. Trauma Team Activation (TTA) 3. Abnormal acute intracranial CT/MRI&#xD;
        findings 4. Blood alcohol level (&gt; 200 mg/dL) 5. Previous head injury within 30 days of&#xD;
        enrollment 6. Pre-existing neurologic disorder associated with cerebral dysfunction and/or&#xD;
        cognitive deficit (such as dementia, cerebral palsy, mental retardation, epilepsy,&#xD;
        dyslexia) 7. Pre-existing psychiatric disorder (such as bipolar disorder and schizophrenia)&#xD;
        as indicated by medical history 8. Planned admission to a hospital inpatient unit&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sandi Wewerka, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Regions Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Regions Hospital</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>September 5, 2018</last_update_submitted>
  <last_update_submitted_qc>September 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2018</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>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to share IPD</ipd_description>
  </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/NCT02992327
org study id: A15-085
nct id: NCT02992327
lead sponsor: 
collaborator: 
has dmc: No
The overall research aim of this pilot study is to determine if the structural brain protein
      calpain-cleaved αII-spectrin N-terminal fragment (SNTF) can be used as a blood biomarker to
      accurately identify patients who will have more severe symptoms and reduced neurocognitive
      functioning after sustaining a concussion. Concussion is also referred to as mild traumatic
      brain injury (mTBI) in the literature. Both terms will be used interchangeably throughout
      this application.
The novel aspect of the proposed study relates to the fact that the STNF protein is the first
      evidence that a biomarker in human blood can help clinicians determine a specific patient's
      clinical outcome from a concussion. This in turn will help clinicians and concussion
      specialists with designing treatment protocols very early after the initial injury that could
      have significant impacts on the health of the patient.

      This study has several important benefits to the scientific community. Concussion treatment
      today is uncertain. Some patients are back to baseline one or two days post injury whereas
      other patients are experiencing debilitating symptoms for months after the injury. Until the
      patient begins to report symptoms, the course of treatment cannot be determined. Other
      biomarkers for concussion diagnosis are being evaluated, but this is the first biomarker to
      show promise for patient stratification and earlier intervention and treatment for the subset
      of cases at high risk of suffering brain damage and persisting dysfunction after concussion.
      Currently, no prognostic method exists for identifying at an early and potentially treatable
      stage the small subset of concussion sufferers at risk of diffuse axonal injury and
      persisting brain functional impairment.
observational model: Cohort
time perspective: Prospective
measure: Results of neurocognitive testing
time frame: 30 days from index injury
description: Neurocognitive testing a 30 days post injury to assess symptom severity
measure: Symptom severity
time frame: 30 days post injury
description: assay level of SNTF biomarker
measure: SNTF plasma and serum levels
time frame: 24 hours, 30 days and 90 days post injury
description: SNTF plasma and serum levels measured with 24 hours of injury, at 30 days, at 90 days.
arm group label: Cohort
description: Patients age ≥ 8 years of age with a GCS >13 presenting to the emergency department with a diagnosis of concussion.
The laboratory has developed and characterized extensively an antibody that reacts with the
      SNTF (structural brain protein calpain-cleaved αII-spectrin N-terminal fragment) fragment of
      aII-spectrin but does not recognize either the intact aII-spectrin or any other fragment of
      it. The laboratory has used this antibody as a foundation for an ultrasensitive, specific,
      standardized sandwich immunoassay for measuring trace quantities of SNTF in human serum and
      plasma in the acute period after brain injury19,27 The method employs state-of-the-art
      electrochemiluminescence chemistry that is widely used in the clinical diagnostics arena for
      measuring protein biomarkers in biological fluids.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 8 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sandi Wewerka, MPH
role: Principal Investigator
affiliation: Regions Hospital
facility: 
country: United States
responsible party type: Sponsor
mesh term: Brain Concussion
mesh term: Cognitive Dysfunction
sharing ipd: No
ipd description: There is no plan to share IPD