<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/NCT02218216</url>
  </required_header>
  <id_info>
    <org_study_id>114-2014-GES-0046</org_study_id>
    <nct_id>NCT02218216</nct_id>
  </id_info>
  <brief_title>TBI MR Study 3 Houston Methodist</brief_title>
  <official_title>Advanced MRI Applications for Mild Traumatic Brain Injury - Study 3</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>GE Healthcare</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>GE Healthcare</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This hypothesis-generating feasibility study to determine potential associations between a&#xD;
      broad range of clinical neurological symptoms and Magnetic Resonance Image (MRI), data, and&#xD;
      clinical findings involved in mild traumatic brain injury (mTBI). These associations will be&#xD;
      examined over the acute and sub-acute period (baseline to 3 months) following injury to&#xD;
      provide information useful for optimization of MR pulse sequences for mTBI applications.&#xD;
&#xD;
      The intent of this study is to broadly generate a range of potential mTBI biomarkers&#xD;
      detectable using investigational MR pulse sequence technologies. Feasibility data attained in&#xD;
      this study may be used for engineering program decision-making and in support of future&#xD;
      scientific assessment, engineering development, published research databases or registries&#xD;
      mTBI data and images, and other purposes determined by the Sponsor. The results of this study&#xD;
      are not intended for use in regulatory submissions.&#xD;
&#xD;
      Subjects will be examined on commercially available MR scanner using investigational or&#xD;
      standard of care MR coils and a series of investigational Application Packs containing a&#xD;
      predetermined set of MR pulse sequences optimized by Sponsor&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This hypothesis-generating feasibility study is being conducted to determine potential&#xD;
      associations between a broad range of clinical neurological symptoms and MR images, data, and&#xD;
      clinical findings involved in mild traumatic brain injury (mTBI). These associations will be&#xD;
      examined over the acute and sub-acute period (approximately 3 months) following injury to&#xD;
      provide information useful for optimization of MR pulse sequences for mTBI applications.&#xD;
&#xD;
      The intent of this study is to broadly generate a range of potential mTBI biomarkers&#xD;
      detectable using investigational MR pulse sequence technologies. Feasibility data attained in&#xD;
      this study may be used for engineering program decision-making and in support of future&#xD;
      scientific assessment, engineering development, published research databases or registries&#xD;
      mTBI data and images, and other purposes determined by the Sponsor. The results of this study&#xD;
      are not intended for use in regulatory submissions.&#xD;
&#xD;
      Subjects will be examined on commercially available MR scanners using investigational or&#xD;
      standard of care MR coils and a series of investigational Application Packs containing a&#xD;
      predetermined set of MR pulse sequences optimized by GEHC.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor terminated study early to start a larger feasability study&#xD;
  </why_stopped>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>mTBI Progression Indicated by Clinical Neurological Characteristics, MRI Images, and Quantitative MRI Data From Novel Software</measure>
    <time_frame>Baseline to 3 months</time_frame>
    <description>To determine associations between clinical neurological data, MR images, quantitative data from novel software post-processing (sponsor developed software including Volumetry, Kurtosis, Resting State [RS], functional magnetic resonance imaging [fMRI], and additional post-processing modules may be provided</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>Experimental: Diagnostic mTBI</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental: Diagnostic Non mTBI</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>MRI Diagnostic of Non injured subjects that are closely matched to mTBI</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MRI Diagnostic</intervention_name>
    <description>Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences</description>
    <arm_group_label>Experimental: Diagnostic Non mTBI</arm_group_label>
    <arm_group_label>Experimental: Diagnostic mTBI</arm_group_label>
    <other_name>Magnetic Resonance Image</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Segment 1 (mTBI patient) Inclusion and Exclusion Criteria Inclusion Criteria for mTBI&#xD;
        subjects&#xD;
&#xD;
        Subjects included in the main part of this study (Segment 1) will:&#xD;
&#xD;
          1. Be aged ≥15 and ≤50 years old at the time of enrollment;&#xD;
&#xD;
          2. Be diagnosed with mTBI according to the standard diagnostic procedures at the&#xD;
             investigational site in a timeframe that meets enrollment criteria for enrollment in&#xD;
             one of the first two intervals of the study, as follows:&#xD;
&#xD;
               1. Meets criteria for enrollment in Encounter 1 (within 72 hours), or&#xD;
&#xD;
               2. Meets criteria for enrollment in Encounter 2 (within 8±2 days)&#xD;
&#xD;
          3. Be capable of sufficiently clear communication to allow the subject to provide written&#xD;
             informed consent, or assent with parental or guardian consent for minors as described&#xD;
             in Section 6.3 - Protection of Vulnerable Subjects, for participation in all parts of&#xD;
             the study.&#xD;
&#xD;
        Segment 1: Exclusion Criteria for mTBI subjects&#xD;
&#xD;
        Subjects will be excluded that have:&#xD;
&#xD;
          1. Loss of consciousness (LOC) ≥15 minutes;&#xD;
&#xD;
          2. Posttraumatic amnesia lasting ≥24 hr following a recent TBI event;&#xD;
&#xD;
          3. Diagnosis of moderate to severe TBI or GCS &lt;13;&#xD;
&#xD;
          4. Structural brain injury indicated by previous neuroimaging findings;&#xD;
&#xD;
          5. Previous history of moderate to severe TBI;&#xD;
&#xD;
          6. Any previous history of mild TBI within the past 12 months;&#xD;
&#xD;
          7. Previously diagnosed brain white matter disease;&#xD;
&#xD;
          8. History of seizures within the past 10 years;&#xD;
&#xD;
          9. History of self-reported illicit drug abuse (except marijuana) in past 10 years;&#xD;
&#xD;
         10. History of alcohol abuse or dependence (per DSM-IV-TR Diagnostic Criteria);&#xD;
&#xD;
         11. Current primary Axis I or II psychiatric disorders, except for disorders classified as&#xD;
             minor and not expected to impact study conduct or integrity (as detailed in Appendix F&#xD;
             - Screening for Exclusion based on Axis I or II Disorders):&#xD;
&#xD;
         12. History of brain mass;&#xD;
&#xD;
         13. History of neurosurgery;&#xD;
&#xD;
         14. History of stroke;&#xD;
&#xD;
         15. History of dementia;&#xD;
&#xD;
         16. Known cognitive dysfunction;&#xD;
&#xD;
         17. Known structural brain disease or malformation;&#xD;
&#xD;
         18. Current anti-psychotic or antiepileptic medication usage;&#xD;
&#xD;
         19. That are unable or unwilling to complete study procedures accurately or have any&#xD;
             conflict of interest that could affect study results, in the opinion of the&#xD;
             investigator;&#xD;
&#xD;
         20. Contraindications to MRI scanning, including:&#xD;
&#xD;
               1. Current or suspected pregnancy per site clinical practice;&#xD;
&#xD;
               2. Other conditions that may constitute a hazard to the subject during study&#xD;
                  participation, determined by the investigator;&#xD;
&#xD;
               3. Inability to comply with any part of the site's MR safety policy.&#xD;
&#xD;
        Segment 2 (non-TBI subject) Inclusion and Exclusion Criteria Inclusion Criteria for Non-TBI&#xD;
        subjects (Segment 2)&#xD;
&#xD;
        All included subjects will:&#xD;
&#xD;
          1. Aged ≥15 and ≤50 years old at the time of enrollment;&#xD;
&#xD;
          2. Be well matched to one or more mTBI patients in Segment 1, in the opinion of the&#xD;
             Principal Investigator, with regards to:&#xD;
&#xD;
               1. Age,&#xD;
&#xD;
               2. Gender,&#xD;
&#xD;
               3. Sociodemographic characteristics, and&#xD;
&#xD;
               4. Handedness.&#xD;
&#xD;
          3. Be capable of sufficiently clear communication to allow the subject to provide written&#xD;
             informed consent, or assent with parental or guardian consent for minors as described&#xD;
             in Section 6.3 - Protection of Vulnerable Subjects, for participation in all parts of&#xD;
             the study.&#xD;
&#xD;
        Exclusion Criteria for Non-TBI subjects (Segment 2)&#xD;
&#xD;
        Subjects will be excluded that:&#xD;
&#xD;
          1. Are currently pregnant based on subject self-report of pregnancy status;&#xD;
&#xD;
          2. Are currently enrolled in another Segment of this study;&#xD;
&#xD;
          3. Require medical care that would be adversely affected or delayed by participating, in&#xD;
             the opinion of a physician investigator;&#xD;
&#xD;
          4. Prior diagnosis of mild TBI within the past 12 months;&#xD;
&#xD;
          5. Have structural brain injury indicated by previous neuroimaging findings;&#xD;
&#xD;
          6. Previous history of moderate to severe TBI within the past 10 years;&#xD;
&#xD;
          7. Previously diagnosed brain white matter disease;&#xD;
&#xD;
          8. History of seizures within the past 10 years;&#xD;
&#xD;
          9. History of illicit drug abuse (except marijuana) within the past 10 years&#xD;
&#xD;
         10. History of alcohol abuse or dependence (per DSM-IV-TR Diagnostic Criteria);&#xD;
&#xD;
         11. Current primary Axis I or II psychiatric disorders, except for disorders classified as&#xD;
             minor and not expected to impact study conduct or integrity (as detailed in Appendix F&#xD;
             - Screening for Exclusion based on Axis I or II Disorders):&#xD;
&#xD;
         12. History of brain mass;&#xD;
&#xD;
         13. History of neurosurgery;&#xD;
&#xD;
         14. History of stroke;&#xD;
&#xD;
         15. History of dementia;&#xD;
&#xD;
         16. Known cognitive dysfunction;&#xD;
&#xD;
         17. Known structural brain disease or malformation;&#xD;
&#xD;
         18. Current anti-psychotic or antiepileptic medication usage;&#xD;
&#xD;
         19. Have contraindications to MRI scanning, including:&#xD;
&#xD;
               1. Current or suspected pregnancy per site clinical practice;&#xD;
&#xD;
               2. Other conditions that may constitute a hazard to the subject during study&#xD;
                  participation, determined by the investigator;&#xD;
&#xD;
               3. Inability to comply with any part of the site's MR safety policy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joseph C Masdeu, MD. PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Houston Methodist Neurological Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Houston Methodist Neurological Institute</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <results_first_submitted>April 27, 2017</results_first_submitted>
  <results_first_submitted_qc>June 22, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">July 24, 2017</results_first_posted>
  <last_update_submitted>June 22, 2017</last_update_submitted>
  <last_update_submitted_qc>June 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mild Traumatic Brain Injury</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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Volunteer Control participants were scanned only for the purpose of operator training and calibrating the MRI device. No data was collected from these participants for the the purpose of analysis.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Experimental: Diagnostic mTBI</title>
          <description>MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)&#xD;
MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences</description>
        </group>
        <group group_id="P2">
          <title>Experimental: Diagnostic Non mTBI</title>
          <description>MRI Diagnostic of Non injured subjects that are closely matched to mTBI&#xD;
MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences</description>
        </group>
        <group group_id="P3">
          <title>Volunteers</title>
          <description>MRI Diagnostic of Volunteer Controls for Device Calibration&#xD;
MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Study terminated before completed</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Experimental: Diagnostic mTBI</title>
          <description>MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)&#xD;
MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences</description>
        </group>
        <group group_id="B2">
          <title>Experimental: Diagnostic Non mTBI</title>
          <description>MRI Diagnostic of Non injured subjects that are closely matched to mTBI&#xD;
MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="14"/>
            <count group_id="B2" value="2"/>
            <count group_id="B3" value="16"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>mTBI Progression Indicated by Clinical Neurological Characteristics, MRI Images, and Quantitative MRI Data From Novel Software</title>
        <description>To determine associations between clinical neurological data, MR images, quantitative data from novel software post-processing (sponsor developed software including Volumetry, Kurtosis, Resting State [RS], functional magnetic resonance imaging [fMRI], and additional post-processing modules may be provided</description>
        <time_frame>Baseline to 3 months</time_frame>
        <population>Study was terminated and no subject outcome data were collected</population>
        <group_list>
          <group group_id="O1">
            <title>Experimental: Diagnostic mTBI</title>
            <description>MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)&#xD;
MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences</description>
          </group>
          <group group_id="O2">
            <title>Experimental: Diagnostic Non mTBI</title>
            <description>MRI Diagnostic of Non injured subjects that are closely matched to mTBI&#xD;
MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences</description>
          </group>
          <group group_id="O3">
            <title>Volunteers</title>
            <description>MRI Diagnostic of Volunteer Controls for Device Calibration&#xD;
MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences</description>
          </group>
        </group_list>
        <measure>
          <title>mTBI Progression Indicated by Clinical Neurological Characteristics, MRI Images, and Quantitative MRI Data From Novel Software</title>
          <description>To determine associations between clinical neurological data, MR images, quantitative data from novel software post-processing (sponsor developed software including Volumetry, Kurtosis, Resting State [RS], functional magnetic resonance imaging [fMRI], and additional post-processing modules may be provided</description>
          <population>Study was terminated and no subject outcome data were collected</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data was collected during the period of participant enrollment.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Experimental: Diagnostic mTBI</title>
          <description>MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)&#xD;
MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences</description>
        </group>
        <group group_id="E2">
          <title>Experimental: Diagnostic Non mTBI</title>
          <description>MRI Diagnostic of Non injured subjects that are closely matched to mTBI&#xD;
MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences</description>
        </group>
        <group group_id="E3">
          <title>Volunteer Controls</title>
          <description>Non injured volunteers for device calibration&#xD;
Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="14"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Headache/Dizziness</sub_title>
                <description>Subject experienced headache/dizziness after MRI</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Influenza</sub_title>
                <description>Subject diagnosed with influenza during the study</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="3"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Early termination due to limited enrollment</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Chief Medical Officer - Head Health Initiative</name_or_title>
      <organization>GE Healthcare</organization>
      <phone>262-544-3633</phone>
      <email>Victor.Miranda@ge.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02218216
org study id: 114-2014-GES-0046
nct id: NCT02218216
lead sponsor: 
has dmc: No
This hypothesis-generating feasibility study to determine potential associations between a
      broad range of clinical neurological symptoms and Magnetic Resonance Image (MRI), data, and
      clinical findings involved in mild traumatic brain injury (mTBI). These associations will be
      examined over the acute and sub-acute period (baseline to 3 months) following injury to
      provide information useful for optimization of MR pulse sequences for mTBI applications.

      The intent of this study is to broadly generate a range of potential mTBI biomarkers
      detectable using investigational MR pulse sequence technologies. Feasibility data attained in
      this study may be used for engineering program decision-making and in support of future
      scientific assessment, engineering development, published research databases or registries
      mTBI data and images, and other purposes determined by the Sponsor. The results of this study
      are not intended for use in regulatory submissions.

      Subjects will be examined on commercially available MR scanner using investigational or
      standard of care MR coils and a series of investigational Application Packs containing a
      predetermined set of MR pulse sequences optimized by Sponsor
This hypothesis-generating feasibility study is being conducted to determine potential
      associations between a broad range of clinical neurological symptoms and MR images, data, and
      clinical findings involved in mild traumatic brain injury (mTBI). These associations will be
      examined over the acute and sub-acute period (approximately 3 months) following injury to
      provide information useful for optimization of MR pulse sequences for mTBI applications.

      The intent of this study is to broadly generate a range of potential mTBI biomarkers
      detectable using investigational MR pulse sequence technologies. Feasibility data attained in
      this study may be used for engineering program decision-making and in support of future
      scientific assessment, engineering development, published research databases or registries
      mTBI data and images, and other purposes determined by the Sponsor. The results of this study
      are not intended for use in regulatory submissions.

      Subjects will be examined on commercially available MR scanners using investigational or
      standard of care MR coils and a series of investigational Application Packs containing a
      predetermined set of MR pulse sequences optimized by GEHC.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: mTBI Progression Indicated by Clinical Neurological Characteristics, MRI Images, and Quantitative MRI Data From Novel Software
time frame: Baseline to 3 months
description: To determine associations between clinical neurological data, MR images, quantitative data from novel software post-processing (sponsor developed software including Volumetry, Kurtosis, Resting State [RS], functional magnetic resonance imaging [fMRI], and additional post-processing modules may be provided
arm group label: Experimental: Diagnostic mTBI
arm group type: Experimental
description: MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)
arm group label: Experimental: Diagnostic Non mTBI
arm group type: Placebo Comparator
description: MRI Diagnostic of Non injured subjects that are closely matched to mTBI
intervention type: Device
intervention name: MRI Diagnostic
description: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences
arm group label: Experimental: Diagnostic Non mTBI
arm group label: Experimental: Diagnostic mTBI
other name: Magnetic Resonance Image
criteria: 
gender: All
minimum age: 15 Years
maximum age: 50 Years
healthy volunteers: No
last name: Joseph C Masdeu, MD. PhD
role: Principal Investigator
affiliation: Houston Methodist Neurological Institute
facility: 
country: United States
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Early termination due to limited enrollment
point of contact: 