<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/NCT01712698</url>
  </required_header>
  <id_info>
    <org_study_id>DTI</org_study_id>
    <secondary_id>Washington University</secondary_id>
    <nct_id>NCT01712698</nct_id>
  </id_info>
  <brief_title>Diffusion Tensor Imaging to Assess the Functional Outcomes of Adults With Cervical Spinal Cord Injuries</brief_title>
  <official_title>Diffusion Tensor MRI to Assess Subacute Functional Outcomes in Patients With Acute Cervical Spinal Cord Injuries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acute changes in axial diffusivity will correlate with the severity of injury in patients&#xD;
      that suffer an acute spinal cord injury.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Diffusion tensor imaging (DTI) parameters will correlate with severity of spinal cord injury&#xD;
      in SCI patients as seen in rodent models. We will test whether the quantitative decrease in&#xD;
      axial (λ║) diffusivity (a biomarker of axonal injury), will predict long-term functional&#xD;
      outcomes for patients with a SCI.&#xD;
&#xD;
      Specific Aim: To examine patients after an acute SCI using DTI and to correlate the extent of&#xD;
      acute decrease in λ║ with the presenting ASIA motor score and long-term functional outcome of&#xD;
      the patient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</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>Change in AISA score</measure>
    <time_frame>24 months</time_frame>
    <description>Patients will be followed for the duration of their hospital stay with clinical follow-up out to 2 years. ASIA scores will be correlated with admission DTI findings(Axial Diffusivity).</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Cervical Spinal Cord Injury</condition>
  <arm_group>
    <arm_group_label>Cervical spinal cord injury</arm_group_label>
    <description>Those patients with an acute cervical spinal cord injury evaluated with DTI MRI</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with a traumatic cervical spinal cord injury&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-65 years of age&#xD;
&#xD;
          -  Cervical spinal cord injury&#xD;
&#xD;
          -  physically and mentally willing to comply with imaging&#xD;
&#xD;
          -  lives in immediate area with no plans to relocate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Associated moderate to severe head injury&#xD;
&#xD;
          -  Active malignancy&#xD;
&#xD;
          -  Previous spinal cord injury&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  inability to tolerate MRI scanning&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Washington University, School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <last_update_submitted>April 30, 2018</last_update_submitted>
  <last_update_submitted_qc>April 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>trauma</keyword>
  <keyword>spinal cord injury</keyword>
  <keyword>cervical spine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
    <mesh_term>Wounds and Injuries</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/NCT01712698
org study id: DTI
secondary id: Washington University
nct id: NCT01712698
lead sponsor: 
has dmc: No
Acute changes in axial diffusivity will correlate with the severity of injury in patients
      that suffer an acute spinal cord injury.
Diffusion tensor imaging (DTI) parameters will correlate with severity of spinal cord injury
      in SCI patients as seen in rodent models. We will test whether the quantitative decrease in
      axial (λ║) diffusivity (a biomarker of axonal injury), will predict long-term functional
      outcomes for patients with a SCI.

      Specific Aim: To examine patients after an acute SCI using DTI and to correlate the extent of
      acute decrease in λ║ with the presenting ASIA motor score and long-term functional outcome of
      the patient.
observational model: Cohort
time perspective: Prospective
measure: Change in AISA score
time frame: 24 months
description: Patients will be followed for the duration of their hospital stay with clinical follow-up out to 2 years. ASIA scores will be correlated with admission DTI findings(Axial Diffusivity).
arm group label: Cervical spinal cord injury
description: Those patients with an acute cervical spinal cord injury evaluated with DTI MRI
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Spinal Cord Injuries
mesh term: Wounds and Injuries