<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/NCT02997930</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201601806</org_study_id>
    <secondary_id>OCR18886</secondary_id>
    <nct_id>NCT02997930</nct_id>
  </id_info>
  <brief_title>fMRI Connectivity in Fracture Hip Patients</brief_title>
  <official_title>Functional Connectivity (With fMRI) as an Objective Measure of Postoperative Cognitive Function in Elderly Fracture Hip Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florida</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>
      The long-term goal of this study is to evaluate cognitive function preoperatively and develop&#xD;
      techniques of intervention in the perioperative period which would optimize brain function&#xD;
      and functional recovery following surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this protocol, subjects who are anticipated to be operated for hip fracture will be&#xD;
      studied after surgery. Brief cognitive exam will be done followed by fMRI of connectivity and&#xD;
      diffusion tensor imaging (DTI). Connectivity (neuronal changes) and DTI (Anisotropy and mean&#xD;
      diffusivity) data will be compared with age matched controls and correlated with subjective&#xD;
      measures of cognition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 29, 2017</start_date>
  <completion_date type="Actual">May 6, 2019</completion_date>
  <primary_completion_date type="Actual">May 6, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes between baseline and follow up visits as assessed by fMRI</measure>
    <time_frame>Change from baseline up to 90 days</time_frame>
    <description>fMRI for measuring function connectivity and DTI</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes between baseline and follow up visits as assessed by MoCA</measure>
    <time_frame>Change from baseline up to 90 days</time_frame>
    <description>A measure of general cognition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes between baseline and follow up visits as assessed by Digital Clock Drawing Test Command and Copy</measure>
    <time_frame>Change from baseline up to 90 days</time_frame>
    <description>a measure of current cognition using digital pen technology</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes between baseline and follow up visits as assessed by Wide Range Achievement Test reading subtest</measure>
    <time_frame>Change from baseline up to 90 days</time_frame>
    <description>A measure of premorbid intellectual estimate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes between baseline and follow up visits as assessed by HVLT</measure>
    <time_frame>Change from baseline up to 90 days</time_frame>
    <description>A measure of declarative memory</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Postoperative Delirium</condition>
  <condition>Postoperative Cognitive Dysfunction</condition>
  <arm_group>
    <arm_group_label>Elderly Hip Fracture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Postoperative assess cognitive function in elderly subjects after fracture hip surgery. Measure function connectivity and DTI (diffusion tensor imaging) via: fMRI. Subjective measures will include: Montreal Cognitive Assessment (MoCA), Digital Clock Drawing Test Command and Copy, Wide Range Achievement Test reading subtest, Hopkins Verbal Learning Test (HVLT), General Depression Scale (GDS)</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>fMRI</intervention_name>
    <description>fMRI for measuring function connectivity and DTI will be done between day 2 to day 5.</description>
    <arm_group_label>Elderly Hip Fracture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Montreal Cognitive Assessment (MoCA)</intervention_name>
    <description>A measure of general cognition</description>
    <arm_group_label>Elderly Hip Fracture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Digital Clock Drawing Test Command and Copy</intervention_name>
    <description>A measure of current cognition using digital pen technology</description>
    <arm_group_label>Elderly Hip Fracture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Wide Range Achievement Test reading subtest</intervention_name>
    <description>A measure of premorbid intellectual estimate</description>
    <arm_group_label>Elderly Hip Fracture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Hopkins Verbal Learning Test (HVLT)</intervention_name>
    <description>A measure of declarative memory</description>
    <arm_group_label>Elderly Hip Fracture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>General Depression Scale (GDS)</intervention_name>
    <description>A measure of the of presence of depression.</description>
    <arm_group_label>Elderly Hip Fracture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients 65 years and older&#xD;
&#xD;
          -  Patients who have fracture hip and are anticipated to have surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have contraindications for MRI like pacemaker, automatic implanted&#xD;
             cardiac defibrillator (AICD), implanted infusion pumps etc.&#xD;
&#xD;
          -  Patients who are claustrophobic&#xD;
&#xD;
          -  Patients with severe cognitive impairment (who may not be able to cooperate during the&#xD;
             cognitive exam and fMRI)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ramachandran Ramani, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UF Health</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>August 9, 2019</last_update_submitted>
  <last_update_submitted_qc>August 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 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>Emergence Delirium</mesh_term>
    <mesh_term>Postoperative Cognitive Complications</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02997930
org study id: IRB201601806
secondary id: OCR18886
nct id: NCT02997930
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The long-term goal of this study is to evaluate cognitive function preoperatively and develop
      techniques of intervention in the perioperative period which would optimize brain function
      and functional recovery following surgery.
In this protocol, subjects who are anticipated to be operated for hip fracture will be
      studied after surgery. Brief cognitive exam will be done followed by fMRI of connectivity and
      diffusion tensor imaging (DTI). Connectivity (neuronal changes) and DTI (Anisotropy and mean
      diffusivity) data will be compared with age matched controls and correlated with subjective
      measures of cognition.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Changes between baseline and follow up visits as assessed by fMRI
time frame: Change from baseline up to 90 days
description: fMRI for measuring function connectivity and DTI
measure: Changes between baseline and follow up visits as assessed by MoCA
time frame: Change from baseline up to 90 days
description: A measure of general cognition
measure: Changes between baseline and follow up visits as assessed by Digital Clock Drawing Test Command and Copy
time frame: Change from baseline up to 90 days
description: a measure of current cognition using digital pen technology
measure: Changes between baseline and follow up visits as assessed by Wide Range Achievement Test reading subtest
time frame: Change from baseline up to 90 days
description: A measure of premorbid intellectual estimate
measure: Changes between baseline and follow up visits as assessed by HVLT
time frame: Change from baseline up to 90 days
description: A measure of declarative memory
arm group label: Elderly Hip Fracture
arm group type: Experimental
description: Postoperative assess cognitive function in elderly subjects after fracture hip surgery. Measure function connectivity and DTI (diffusion tensor imaging) via: fMRI. Subjective measures will include: Montreal Cognitive Assessment (MoCA), Digital Clock Drawing Test Command and Copy, Wide Range Achievement Test reading subtest, Hopkins Verbal Learning Test (HVLT), General Depression Scale (GDS)
intervention type: Behavioral
intervention name: fMRI
description: fMRI for measuring function connectivity and DTI will be done between day 2 to day 5.
arm group label: Elderly Hip Fracture
intervention type: Behavioral
intervention name: Montreal Cognitive Assessment (MoCA)
description: A measure of general cognition
arm group label: Elderly Hip Fracture
intervention type: Behavioral
intervention name: Digital Clock Drawing Test Command and Copy
description: A measure of current cognition using digital pen technology
arm group label: Elderly Hip Fracture
intervention type: Behavioral
intervention name: Wide Range Achievement Test reading subtest
description: A measure of premorbid intellectual estimate
arm group label: Elderly Hip Fracture
intervention type: Behavioral
intervention name: Hopkins Verbal Learning Test (HVLT)
description: A measure of declarative memory
arm group label: Elderly Hip Fracture
intervention type: Behavioral
intervention name: General Depression Scale (GDS)
description: A measure of the of presence of depression.
arm group label: Elderly Hip Fracture
criteria: 
gender: All
minimum age: 65 Years
maximum age: 99 Years
healthy volunteers: No
last name: Ramachandran Ramani, MD
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
responsible party type: Sponsor
mesh term: Emergence Delirium
mesh term: Postoperative Cognitive Complications
mesh term: Cognitive Dysfunction
sharing ipd: No