<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/NCT02251002</url>
  </required_header>
  <id_info>
    <org_study_id>1408M53005</org_study_id>
    <nct_id>NCT02251002</nct_id>
  </id_info>
  <brief_title>Frontoparietal Priority Maps as Biomarkers for MTBI</brief_title>
  <official_title>Frontoparietal Priority Maps as Biomarkers for MTBI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Minnesota</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether there is a quantitative relationship&#xD;
      between brain processes seen by a MRI and visual deficits caused by mild to moderate&#xD;
      traumatic brain injuries (mTBI).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants with mTBI, as well as healthy control participants, will be invited to&#xD;
      participate in up to two study visits. Both visits will occur at the University of&#xD;
      Minnesota's Center for Magnetic Resonance Research (CMRR). The first study visit will entail&#xD;
      (1) interviews to determine the presence of (and, if present, the severity of) oculomotor&#xD;
      difficulties such as convergence insufficiency, and (2) behavioral measures (e.g., visually&#xD;
      track a moving dot) to assess skill at allocating spatial attention. For participants who&#xD;
      have not before participated in an MRI study at the CMRR, a 15-minute scan to acquire&#xD;
      research-quality anatomical images of the brain will be acquired at the end of the first&#xD;
      visit. A subset of the approximately 88 participants who participate in Visit 1 will be&#xD;
      invited to participate in Visit 2. Visit 2 will be dominated by a 90-minute scanning session&#xD;
      in the 7 Tesla scanner, during which participants will perform a 10-minute spatial attention&#xD;
      task and a 10-minute eye movement task, and high-resolution diffusion tensor imaging data&#xD;
      will be acquired while participants enjoy the movie of their choice in the scanner.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2015</start_date>
  <completion_date type="Actual">October 2018</completion_date>
  <primary_completion_date type="Actual">February 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>oculomotor performance</measure>
    <time_frame>study enrollment / baseline</time_frame>
    <description>Oculomotor performance will be measured with behavioral questionnaires, eye-charts, and computerized eye-tracking while subjects perform saccades and smooth pursuit motions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>frontoparietal priority maps</measure>
    <time_frame>baseline</time_frame>
    <description>Functional MRI data will be collected at 7 Tesla while subjects perform spatial attention and eye movement tasks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>white matter integrity</measure>
    <time_frame>baseline</time_frame>
    <description>Diffusion tensor imaging data will be acquired at 7 Tesla and analyzed in a priori regions of interest adjacent to frontal and parietal functional regions of interest.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">88</enrollment>
  <condition>TBI (Traumatic Brain Injury)</condition>
  <condition>Ocular Motility Disorders</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>no history of TBI or neurologic disorder</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mTBI</arm_group_label>
    <description>documented past mild to moderate TBI</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Participants with mTBI who have previously participated in MRI studies; preference will be&#xD;
        given to individuals with visual complaints such as blurred or double vision or headaches&#xD;
        while reading. Participants with no history of TBI and no visual complaints will also be&#xD;
        recruited into a control group.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Normal or corrected to normal visual acuity&#xD;
&#xD;
          -  No previously documented mTBI (target: 16 out of 88 participants invited for Visit 1)&#xD;
&#xD;
          -  Previously documented mTBI (target: 72 out of 88 participants invited for Visit 1)&#xD;
&#xD;
          -  Vision impairment (target: 48 out of 88 participants invited for Visit 1; expected to&#xD;
             be comorbid with mTBI, but non-TBI participants with oculomotor impairments will not&#xD;
             be excluded)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current use of neuroactive drugs or medications&#xD;
&#xD;
          -  Presence of neurological disorders (other than mTBI and mild PTSD)&#xD;
&#xD;
          -  Contraindications for MRI (metal in the body, claustrophobia, diabetes or other&#xD;
             diseases or drugs that affect thermoregulation)&#xD;
&#xD;
          -  Inability to comply with behavioral task instructions&#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>Cheryl A Olman, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Minnesota</affiliation>
  </overall_official>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>September 22, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>March 19, 2019</last_update_submitted>
  <last_update_submitted_qc>March 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2019</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 Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Ocular Motility Disorders</mesh_term>
  </condition_browse>
  <!-- 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/NCT02251002
org study id: 1408M53005
nct id: NCT02251002
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether there is a quantitative relationship
      between brain processes seen by a MRI and visual deficits caused by mild to moderate
      traumatic brain injuries (mTBI).
Participants with mTBI, as well as healthy control participants, will be invited to
      participate in up to two study visits. Both visits will occur at the University of
      Minnesota's Center for Magnetic Resonance Research (CMRR). The first study visit will entail
      (1) interviews to determine the presence of (and, if present, the severity of) oculomotor
      difficulties such as convergence insufficiency, and (2) behavioral measures (e.g., visually
      track a moving dot) to assess skill at allocating spatial attention. For participants who
      have not before participated in an MRI study at the CMRR, a 15-minute scan to acquire
      research-quality anatomical images of the brain will be acquired at the end of the first
      visit. A subset of the approximately 88 participants who participate in Visit 1 will be
      invited to participate in Visit 2. Visit 2 will be dominated by a 90-minute scanning session
      in the 7 Tesla scanner, during which participants will perform a 10-minute spatial attention
      task and a 10-minute eye movement task, and high-resolution diffusion tensor imaging data
      will be acquired while participants enjoy the movie of their choice in the scanner.
observational model: Case-Control
time perspective: Prospective
measure: oculomotor performance
time frame: study enrollment / baseline
description: Oculomotor performance will be measured with behavioral questionnaires, eye-charts, and computerized eye-tracking while subjects perform saccades and smooth pursuit motions.
measure: frontoparietal priority maps
time frame: baseline
description: Functional MRI data will be collected at 7 Tesla while subjects perform spatial attention and eye movement tasks.
measure: white matter integrity
time frame: baseline
description: Diffusion tensor imaging data will be acquired at 7 Tesla and analyzed in a priori regions of interest adjacent to frontal and parietal functional regions of interest.
arm group label: Control
description: no history of TBI or neurologic disorder
arm group label: mTBI
description: documented past mild to moderate TBI
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: Cheryl A Olman, PhD
role: Principal Investigator
affiliation: University of Minnesota
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Ocular Motility Disorders