<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/NCT03296592</url>
  </required_header>
  <id_info>
    <org_study_id>NS047592-10-201706177</org_study_id>
    <secondary_id>2R01NS047592-10</secondary_id>
    <nct_id>NCT03296592</nct_id>
  </id_info>
  <brief_title>Diffusion MRI in Cervical Spondylotic Myelopathy (CSM)</brief_title>
  <acronym>CSM</acronym>
  <official_title>Predictive Value of Diffusion MRI in Cervical Spondylotic Myelopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Neurological Disorders and Stroke (NINDS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Washington University School of Medicine</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>
      Patients who have been diagnosed with Cervical Spondylotic Myelopathy will be asked to&#xD;
      undergo an MRI using diffusion basis spectrum imaging (DBSI) technology. The patients will&#xD;
      have this MRI preoperatively and at 24 months postop. The investigators believe that with&#xD;
      this imaging, biomarkers will be able to be seen to assist in prediction of long term&#xD;
      outcomes in patients with spinal cord compression. These patients will be compared to healthy&#xD;
      cohorts who will also undergo an MRI using the DBSI technology.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      CSM is the most common form of spinal cord injury and is the leading cause of progressive&#xD;
      disability in patients over the age of 65. A major shortcoming limiting the clinical&#xD;
      management of CSM is the lack of quantifiable metrics to 1) base clinical decisions and 2)&#xD;
      predict potential for functional recovery following surgical intervention. DBSI MRI will&#xD;
      provide imaging biomarkers to more reliably predict a patient's clinical course, response to&#xD;
      therapy, and long-term prognosis.&#xD;
&#xD;
      Patients who are diagnosed with CSM will have an MRI using the DBSI technology preoperatively&#xD;
      and at 24 months. Surgical patients will be assessed with the Neck Disability Index (NDI),&#xD;
      Disability of the Arm, Shoulder and Hand (DASH), hand grip dynamometer and Manual Muscle&#xD;
      Testing (MMT), the modified Japanese Orthopaedic Association scale (mJOA), and the Major&#xD;
      Depression Inventory (MDI), the Short Form-36 (SF-36) and Nurick scoring.&#xD;
&#xD;
      A control group of healthy volunteers will have an MRI using the DBSI technology when&#xD;
      enrolled and then again between 12-24 months later.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 29, 2018</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">March 30, 2024</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>Accurate prediction of neurologic outcomes after surgery</measure>
    <time_frame>24 months</time_frame>
    <description>Outcome measure will assess spinal cord DBSI pathological metrics at baseline and at 24 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of effects of blood flow deficits on spinal cord pathology</measure>
    <time_frame>24 months</time_frame>
    <description>Outcome measure will assess effects of blood flow deficits on spinal cord pathology and determine the accuracy of axonal loss quantification in CSM</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">71</enrollment>
  <condition>Cervical Spondylotic Myelopathy</condition>
  <arm_group>
    <arm_group_label>Investigational subjects</arm_group_label>
    <description>Patients who have been diagnosed with cervical spondylotic myelopathy and who will be undergoing surgical correction for this diagnosis.&#xD;
Visit 1 Investigational subjects will undergo a clinical assessment. Patients will undergo a DBSI MRI&#xD;
Visit 2. 6 months after surgery, investigational subjects will undergo a clinical assessment.&#xD;
Visit 3 12 months after surgery, investigational subjects will undergo a clinical assessment&#xD;
Visit 4 18 months after surgery, investigational subjects will undergo a clinical assessment.&#xD;
Visit 5 24 months after surgery, investigational subjects will undergo a clinical assessment and a DBSI MRI.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Healthy volunteers aged 45-65 Visit 1: DBSI MRI Visit 2: 24 months after first MRI, patient will undergo the second MRI</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>MRI with DBSI technology</intervention_name>
    <description>The MRI will be done with diffusion basis spectrum imaging</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Investigational subjects</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        We will enroll from our patient population and 20 patients from healthy volunteers.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  History of ongoing spinal cord compression,&#xD;
&#xD;
          -  clinical evidence of CSM as determined by signs and symptoms including, but not&#xD;
             limited to loss of manual dexterity, extremity weakness, sensory abnormalities,&#xD;
             quadriparesis, loss of proprioception, and positive Babinski's or Hoffman's sign.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant&#xD;
&#xD;
          -  having an MRI incompatible device&#xD;
&#xD;
          -  having a known diagnosis of amyotrophic lateral sclerosis, multiple sclerosis,&#xD;
             rheumatoid arthritis, concomitant thoracic and/or lumbar stenosis, spine tumor or&#xD;
             HIV-related myelopathy and having systemic instability or being deemed unable to&#xD;
             tolerate standard MRI sequencing.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wilson Z Ray, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington University</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 2023</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>April 24, 2023</last_update_submitted>
  <last_update_submitted_qc>April 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>myelopathy</keyword>
  <keyword>diffusion MRI</keyword>
  <keyword>spinal cord injury</keyword>
  <keyword>spinal cord compression</keyword>
  <keyword>spondylosis</keyword>
  <keyword>cervical</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Diseases</mesh_term>
    <mesh_term>Bone Marrow Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The investigators will not share individual participant data with other researchers. Aggregate data will be made available at study completion.</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/NCT03296592
org study id: NS047592-10-201706177
secondary id: 2R01NS047592-10
nct id: NCT03296592
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients who have been diagnosed with Cervical Spondylotic Myelopathy will be asked to
      undergo an MRI using diffusion basis spectrum imaging (DBSI) technology. The patients will
      have this MRI preoperatively and at 24 months postop. The investigators believe that with
      this imaging, biomarkers will be able to be seen to assist in prediction of long term
      outcomes in patients with spinal cord compression. These patients will be compared to healthy
      cohorts who will also undergo an MRI using the DBSI technology.
CSM is the most common form of spinal cord injury and is the leading cause of progressive
      disability in patients over the age of 65. A major shortcoming limiting the clinical
      management of CSM is the lack of quantifiable metrics to 1) base clinical decisions and 2)
      predict potential for functional recovery following surgical intervention. DBSI MRI will
      provide imaging biomarkers to more reliably predict a patient's clinical course, response to
      therapy, and long-term prognosis.

      Patients who are diagnosed with CSM will have an MRI using the DBSI technology preoperatively
      and at 24 months. Surgical patients will be assessed with the Neck Disability Index (NDI),
      Disability of the Arm, Shoulder and Hand (DASH), hand grip dynamometer and Manual Muscle
      Testing (MMT), the modified Japanese Orthopaedic Association scale (mJOA), and the Major
      Depression Inventory (MDI), the Short Form-36 (SF-36) and Nurick scoring.

      A control group of healthy volunteers will have an MRI using the DBSI technology when
      enrolled and then again between 12-24 months later.
observational model: Cohort
time perspective: Prospective
measure: Accurate prediction of neurologic outcomes after surgery
time frame: 24 months
description: Outcome measure will assess spinal cord DBSI pathological metrics at baseline and at 24 months.
measure: Assessment of effects of blood flow deficits on spinal cord pathology
time frame: 24 months
description: Outcome measure will assess effects of blood flow deficits on spinal cord pathology and determine the accuracy of axonal loss quantification in CSM
arm group label: Investigational subjects
description: Patients who have been diagnosed with cervical spondylotic myelopathy and who will be undergoing surgical correction for this diagnosis.
Visit 1 Investigational subjects will undergo a clinical assessment. Patients will undergo a DBSI MRI
Visit 2. 6 months after surgery, investigational subjects will undergo a clinical assessment.
Visit 3 12 months after surgery, investigational subjects will undergo a clinical assessment
Visit 4 18 months after surgery, investigational subjects will undergo a clinical assessment.
Visit 5 24 months after surgery, investigational subjects will undergo a clinical assessment and a DBSI MRI.
arm group label: Control group
description: Healthy volunteers aged 45-65 Visit 1: DBSI MRI Visit 2: 24 months after first MRI, patient will undergo the second MRI
intervention type: Diagnostic Test
intervention name: MRI with DBSI technology
description: The MRI will be done with diffusion basis spectrum imaging
arm group label: Control group
arm group label: Investigational subjects
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Wilson Z Ray, MD
role: Principal Investigator
affiliation: Washington University School of Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Spinal Cord Diseases
mesh term: Bone Marrow Diseases
sharing ipd: No
ipd description: The investigators will not share individual participant data with other researchers. Aggregate data will be made available at study completion.